Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] .

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Prior to initiating treatment with central nervous system (CNS) stimulants, including methylphenidate hydrochloride extended-release capsules (LA), assess for the presence of cardiac disease (i.e., perform a careful history, including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)] .

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride extended-release capsules (LA) use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

The recommended starting dose for methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.

Administer methylphenidate hydrochloride extended-release capsules (LA) orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed.

The recommended dose of methylphenidate hydrochloride extended-release capsules (LA) for patients currently taking methylphenidate hydrochloride tablets twice daily or methylphenidate hydrochloride extended-release tablets (SR) is provided below.

<div class="scrollingtable"><table width="85%"> <caption> <span>TABLE 1: Recommended Dose Conversion From Methylphenidate Hydrochloride Tablets or Methylphenidate Hydrochloride Extended-Release Tablets</span> </caption> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Previous Methylphenidate Hydrochloride Tablets or Methylphenidate Hydrochloride Extended-Release Tablets Dose</th><th align="center" class="Rrule">Recommended Methylphenidate Hydrochloride Extended-Release Capsules (LA) Dose</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">5 mg methylphenidate hydrochloride tablets twice daily</td><td align="center" class="Rrule">10 mg once daily</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">10 mg methylphenidate hydrochloride tablets twice daily or 20 mg methylphenidate hydrochloride extended-release tablets</td><td align="center" class="Rrule">20 mg once daily</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">15 mg methylphenidate hydrochloride tablets twice daily</td><td align="center" class="Rrule">30 mg once daily</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">20 mg methylphenidate hydrochloride tablets twice daily or 40 mg of methylphenidate hydrochloride extended-release tablets</td><td align="center" class="Rrule">40 mg once daily</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">30 mg methylphenidate hydrochloride tablets twice daily or 60 mg of methylphenidate hydrochloride extended-release tablets</td><td align="center" class="Rrule">60 mg once daily</td> </tr> </tbody> </table></div>

If switching from other methylphenidate products, discontinue that treatment, and titrate with methylphenidate hydrochloride extended-release capsules (LA) using the titration schedule.

Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)] .

Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release capsules (LA). If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

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{ "type": "ul", "children": [ "Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules (LA). Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate\n \n [see\n \n Adverse Reactions (6.1)].\n \n \n", "Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises\n \n [s\n \n ee\n \n Drug Interactions (7.1)].\n \n \n" ], "text": "" }

CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

Sudden death, stroke, and myocardial infarction have been reported in adults with CNS-stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during methylphenidate hydrochloride extended-release capsules (LA) treatment.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Exacerbation of Preexisting Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release capsules (LA). In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

CNS Stimulants, including methylphenidate hydrochloride extended-release capsules (LA), used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the ages of 10-13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA). Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical program for methylphenidate hydrochloride extended-release capsules (LA) consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received methylphenidate hydrochloride extended-release capsules (LA) in doses of 10 to 40 mg per day. Safety of methylphenidate hydrochloride extended-release capsules (LA) was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight. A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules (LA) in children with ADHD aged 6 to 12 years. All subjects received methylphenidate hydrochloride extended-release capsules (LA) for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind treatment phase of this study, patients received either placebo or methylphenidate hydrochloride extended-release capsules (LA) at their individually-titrated dose (range, 10 to 40 mg).

Adverse reactions with an incidence greater than 5% during the initial 4-week single-blind methylphenidate hydrochloride extended-release capsules (LA) titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia.

Adverse reactions with an incidence greater than 2% among methylphenidate hydrochloride extended-release capsules (LA) -treated subjects, during the 2-week double-blind phase of the clinical study, are shown in Table 2:

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 2: Adverse Reactions in Greater Than 2% Methylphenidate Hydrochloride Extended-Release Capsules (LA)-Treated Subjects in the 2-Week Double-Blind Phase</span> </caption> <col align="left" valign="top" width="25%"/> <col align="center" valign="top" width="37%"/> <col align="center" valign="top" width="38%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Preferred Term</th><th align="center" class="Rrule">Methylphenidate Hydrochloride Extended-Release Capsules (LA) <span class="Underline"> <br/> N = 65 </span> <br/> N (%) </th><th align="center" class="Rrule">Placebo <br/> <span class="Underline">N = 71</span> <br/> N (%) </th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Anorexia</td><td align="center" class="Rrule">2 (3.1)</td><td align="center" class="Rrule">0 (0.0)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Insomnia</td><td align="center" class="Rrule">2 (3.1)</td><td align="center" class="Rrule">0 (0.0)</td> </tr> </tbody> </table></div>

Adverse Events Associated with Discontinuation of Treatment

In the 2-week double-blind treatment phase of a placebo-controlled parallel-group study in children with ADHD, one methylphenidate hydrochloride extended-release capsules (LA)-treated subject (1/65, 1.5%) discontinued due to an adverse event (depressed mood).

In the single-blind titration period of this study, subjects received methylphenidate hydrochloride extended-release capsules (LA) for up to 4 weeks. During this period a total of 6 subjects (6/161, 3.7%) discontinued due to adverse events. The adverse events leading to discontinuation were anger (2 patients), hypomania, anxiety, depressed mood, fatigue, migraine, and lethargy.

The following adverse reactions have been identified during the post approval use of methylphenidate products. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Adverse Reactions Reported With Methylphenidate Hydrochloride Tablets, Methylphenidate Hydrochloride Extended-Release Tablets, and Methylphenidate Hydrochloride Extended- Release Capsules (LA)

Infections and Infestations:nasopharyngitis

Blood and the Lymphatic System Disorders:leukopenia, thrombocytopenia, anemia

Immune System Disorders:hypersensitivity reactions, including angioedema and anaphylaxis

Metabolism and Nutrition Disorders:decreased appetite, reduced weight gain, and suppression of growth during prolonged use in children

Psychiatric Disorders:insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood

Nervous System Disorders:headache, dizziness, tremor, dyskinesia, including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs

Eye Disorders:blurred vision, difficulties in visual accommodation

Cardiac Disorders:tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris

Respiratory, Thoracic, and Mediastinal Disorders:cough

Gastrointestinal Disorders:dry mouth, nausea, vomiting, abdominal pain, dyspepsia

Hepatobiliary Disorders:abnormal liver function, ranging from transaminase elevation to severe hepatic injury

Skin and Subcutaneous Tissue Disorders:hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura

Musculoskeletal and connective tissue disorders:arthralgia, muscle cramps, rhabdomyolysis

Investigations:weight loss (adult ADHD patients)

Adverse Reactions Reported with Other Methylphenidate-Containing Products

The list below shows adverse reactions not listed with methylphenidate hydrochloride tablets, methylphenidate hydrochloride extended-release tablets, or methylphenidate hydrochloride extended-release capsules (LA) formulations that have been reported with other methylphenidate-containing products.

Blood and Lymphatic Disorders: pancytopenia

Immune System Disorders:hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas

Psychiatric Disorders:affect lability, mania, disorientation, libido changes,

Nervous System Disorders:migraine

Eye Disorders:diplopia, mydriasis

Cardiac Disorders:sudden cardiac death, myocardial infarction, bradycardia, extrasystole

Vascular Disorders:peripheral coldness, Raynaud's phenomenon

Respiratory, Thoracic, and Mediastinal Disorders:pharyngolaryngeal pain, dyspnea

Gastrointestinal Disorders:diarrhea, constipation

Skin and Subcutaneous Tissue Disorders:angioneurotic edema, erythema, fixed drug eruption

Musculoskeletal, Connective Tissue, and Bone Disorders:myalgia, muscle twitching

Renal and Urinary Disorders:hematuria

Reproductive System and Breast Disorders:gynecomastia

General Disorders:fatigue, hyperpyrexia

Urogenital Disorders:priapism

Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules (LA)

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 3: Clinically Important Drug Interactions With Methylphenidate Hydrochloride Extended-Release Capsules (LA)</span> </caption> <col align="left" valign="middle" width="20%"/> <col align="left" valign="top" width="80%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Monoamine Oxidase Inhibitors (MAOI)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Clinical Impact</span></td><td align="left" class="Rrule">Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure <span class="Italics">[see <a href="#S4">Contraindications (4)</a>] </span>. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Intervention</span></td><td align="left" class="Rrule">Concomitant use of methylphenidate hydrochloride extended-release capsules (LA) with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Examples</span></td><td align="left" class="Rrule">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Antihypertensive Drugs</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Clinical Impact</span></td><td align="left" class="Rrule">Methylphenidate hydrochloride extended-release capsules (LA) may decrease the effectiveness of drugs used to treat hypertension <span class="Italics">[see <a href="#S5.3">Warnings and Precautions (5.3)</a>] </span>. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Intervention</span></td><td align="left" class="Rrule">Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Examples</span></td><td align="left" class="Rrule">Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Halogenated Anesthetics</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Clinical Impact</span></td><td align="left" class="Rrule">Concomitant use of halogenated anesthetics and methylphenidate hydrochloride extended-release capsules (LA) may increase the risk of sudden blood pressure and heart rate increase during surgery.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Intervention</span></td><td align="left" class="Rrule">Avoid use of methylphenidate hydrochloride extended-release capsules (LA) in patients being treated with anesthetics on the day of surgery.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Italics">Examples</span></td><td align="left" class="Rrule">halothane, isoflurane, enflurane, desflurane, sevoflurane</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Risperidone</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="top"><span class="Italics">Clinical Impact</span></td><td align="left" class="Rrule">Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule"><span class="Italics">Intervention</span></td><td align="left" class="Rrule">Monitor for signs of EPS</td> </tr> </tbody> </table></div>

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules (LA) during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy registry for ADHD medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

CNS stimulants, such as methylphenidate hydrochloride extended-release capsules (LA), can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data

Animal Data

In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m 2basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2basis).

Risk Summary

Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for methylphenidate hydrochloride extended-release capsules (LA) and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules (LA) or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules (LA) for the treatment of ADHD have been established in pediatric patients 6 to 12 years.

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules (LA) in pediatric patients less than 6 years have not been established. The long-term efficacy of methylphenidate hydrochloride extended-release capsules (LA) in pediatric patients has not been established.

Long-Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended release-capsules (LA). Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)] .

Juvenile Animal Toxicity Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis.

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

Methylphenidate hydrochloride extended-release capsules (LA) has not been studied in the geriatric population.

Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride, a Schedule II controlled substance.

CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving.

Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see Overdosage (10)] .

To reduce the abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants [see How Supplied/Storage and Handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets use.

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA).

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants, including methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Human Experience

Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

Overdose Management

Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.

Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant.

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Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.

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The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is

{ "type": "p", "children": [], "text": "The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is" }

Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol." }

Inactive ingredients:Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol.

{ "type": "p", "children": [], "text": "\nInactive ingredients:Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol.\n\n " }

Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

Methylphenidate is a racemic mixture comprised of the d-and l-threoenantiomers. The d-threoenantiomer is more pharmacologically active than the l-threoenantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology

A formal QT study has not been conducted in patients taking methylphenidate hydrochloride extended-release capsules (LA).

The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride tablets, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose. Frederica's method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.

Methylphenidate hydrochloride extended-release capsules (LA) produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when administered orally to children diagnosed with ADHD and healthy adults.

No accumulation of methylphenidate is expected following multiple once daily oral dosing with methylphenidate hydrochloride extended-release capsules (LA), however, there is a slight upward trend in the methylphenidate area under the curve and peak plasma concentrations (C max1and C max2) after oral administration of methylphenidate hydrochloride extended-release capsules (LA) 20 mg and 40 mg to adults.

Absorption

The absolute oral bioavailability of methylphenidate in children was 22 ± 8% for d-methylphenidate and 5 ± 3% for l- methylphenidate. The relative bioavailability of methylphenidate hydrochloride extended-release capsules (LA) given once daily is comparable to the same total dose of methylphenidate hydrochloride tablets given in 2 doses 4 hours apart in both children and adults.

The initial rate of absorption for methylphenidate hydrochloride extended-release capsules (LA) is similar to that of methylphenidate hydrochloride tablets as shown by the similar rate parameters between the 2 formulations, i.e., initial lag time (T lag), first peak concentration (C max1), and time to the first peak (T max1), which is reached in 1 to 3 hours. The mean time to the interpeak minimum (T minip), and time to the second peak (T max2) are also similar for methylphenidate hydrochloride extended-release capsules (LA) given once daily and methylphenidate hydrochloride tablets given in 2 doses 4 hours apart (see Figure 1and Table 1), although the ranges observed are greater for methylphenidate hydrochloride extended-release capsules (LA).

Methylphenidate hydrochloride extended-release capsules (LA) given once daily exhibits a lower second peak concentration (C max2), higher interpeak minimum concentrations (C minip), and less peak and trough fluctuations than methylphenidate hydrochloride tablets given in 2 doses given 4 hours apart. This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1and Table 4).

Figure 1: Mean Plasma Concentration Time-profile of Methylphenidate After a Single Dose of Methylphenidate Hydrochloride Extended-Release Capsule (LA) 40 mg and Methylphenidate Hydrochloride Tablets 20 mg Given in Two Doses 4 Hours Apart

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 4: Mean ± SD and Range of Pharmacokinetic Parameters of Methylphenidate After a Single Dose of Methylphenidate Hydrochloride Extended-Release Capsules (LA) and Methylphenidate Hydrochloride Tablets Given in Two Doses 4 Hours Apart</span> </caption> <col align="left" valign="top" width="12%"/> <col align="center" valign="top" width="22%"/> <col align="center" valign="top" width="22%"/> <col align="center" valign="top" width="22%"/> <col align="center" valign="top" width="22%"/> <thead> <tr class="Botrule First"> <th align="left">Population</th><th align="center" colspan="2">Children</th><th align="center" colspan="2">Adult Males</th> </tr> <tr> <th align="left">Formulation</th><th align="center">Methylphenidate Hydrochloride Tablets</th><th align="center">Methylphenidate Hydrochloride Extended-Release Capsules (LA)</th><th align="center">Methylphenidate Hydrochloride Tablets</th><th align="center">Methylphenidate Hydrochloride Extended-Release Capsules (LA)</th> </tr> <tr class="Last"> <th align="left">Dose <br/> N </th><th align="center">10 mg &amp; 10 mg <br/> 21 </th><th align="center">20 mg <br/> 18 </th><th align="center">10 mg &amp; 10 mg <br/> 9 </th><th align="center">20 mg <br/> 8 </th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>N = 15</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First"> <td align="left"><span class="Bold">T <span class="Sub">lag</span></span>(h) </td><td align="center">0.24 ± 0.44 <br/> 0 – 1 </td><td align="center">0.28 ± 0.46 <br/> 0 - 1 </td><td align="center">1.0 ± 0.5 <br/> 0.7 - 1.3 </td><td align="center">0.7 ± 0.2 <br/> 0.3 - 1.0 </td> </tr> <tr> <td align="left"><span class="Bold">T <span class="Sub">max1</span></span>(h) </td><td align="center">1.8 ± 0.6 <br/> 1 – 3 </td><td align="center">2.0 ± 0.8 <br/> 1 - 3 </td><td align="center">1.9 ± 0.4 <br/> 1.3 - 2.7 </td><td align="center">2.0 ± 0.9 <br/> 1.3 - 4.0 </td> </tr> <tr> <td align="left"><span class="Bold">C <span class="Sub">max1</span></span>(ng/mL) </td><td align="center">10.2 ± 4.2 <br/> 4.2 - 20.2 </td><td align="center">10.3 ± 5.1 <br/> 5.5 - 26.6 </td><td align="center">4.3 ± 2.3 <br/> 1.8 - 7.5 </td><td align="center">5.3 ± 0.9 <br/> 3.8 - 6.9 </td> </tr> <tr> <td align="left"><span class="Bold">T <span class="Sub">minip</span></span>(h) </td><td align="center">4.0 ± 0.2 <br/> 4 – 5 </td><td align="center">4.5 ± 1.2 <br/> 2 - 6 </td><td align="center">3.8 ± 0.4 <br/> 3.3 - 4.3 </td><td align="center">3.6 ± 0.6 <br/> 2.7 - 4.3 </td> </tr> <tr> <td align="left"><span class="Bold">C <span class="Sub">minip</span></span>(ng/mL) </td><td align="center">5.8 ± 2.7 <br/> 3.1 - 14.4 </td><td align="center">6.1 ± 4.1 <br/> 2.9 - 21.0 </td><td align="center">1.2 ± 1.4 <br/> 0.0 - 3.7 </td><td align="center">3.0 ± 0.8 <br/> 1.7 - 4.0 </td> </tr> <tr> <td align="left"><span class="Bold">T <span class="Sub">max2</span></span>(h) </td><td align="center">5.6 ± 0.7 <br/> 5 – 8 </td><td align="center">6.6 ± 1.5 <br/> 5 - 11 </td><td align="center">5.9 ± 0.5 <br/> 5.0 - 6.5 </td><td align="center">5.5 ± 0.8 <br/> 4.3 - 6.5 </td> </tr> <tr> <td align="left"><span class="Bold">C <span class="Sub">max2</span></span>(ng/mL) </td><td align="center">15.3 ± 7.0 <br/> 6.2 - 32.8 </td><td align="center">10.2 ± 5.9 <br/> 4.5 - 31.1 </td><td align="center">5.3 ± 1.4 <br/> 3.6 - 7.2 </td><td align="center">6.2 ± 1.6 <br/> 3.9 - 8.3 </td> </tr> <tr> <td align="left"><span class="Bold">AUC</span><span class="Sub">(0-∞)</span> <br/> (ng/mL × h-1) </td><td align="center">102.4 ± 54.6 <br/> 40.5 - 261.6 </td><td align="center">86.6 ± 64.0 <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> <br/> 43.3 - 301.44 </td><td align="center">37.8 ± 21.9 <br/> 14.3 - 85.3 </td><td align="center">45.8 ± 10.0 <br/> 34.0 - 61.6 </td> </tr> <tr class="Last"> <td align="left"><span class="Bold">t <span class="Sub">1/2</span></span>(h) </td><td align="center">2.5 ± 0.8 <br/> 1.8 - 5.3 </td><td align="center">2.4 ± 0.7 <a class="Sup" href="#footnote-1">*</a> <br/> 1.5 - 4.0 </td><td align="center">3.5 ± 1.9 <br/> 1.3 - 7.7 </td><td align="center">3.3 ± 0.4 <br/> 3.0 - 4.2 </td> </tr> </tbody> </table></div>

Effect of Food

Administration times relative to meals and meal composition may need to be individually titrated.

When methylphenidate hydrochloride extended-release capsules (LA) was administered with a high fat breakfast to adults, methylphenidate hydrochloride extended-release capsules (LA) had a longer lag time until absorption began and variable delays in the time until the first peak concentration, the time until the interpeak minimum, and the time until the second peak. The first peak concentration and the extent of absorption were unchanged after food relative to the fasting state, although the second peak was approximately 25% lower. The effect of a high fat lunch was not examined.

There were no differences in the pharmacokinetics of methylphenidate hydrochloride extended-release capsules (LA) when administered with applesauce, compared to administration in the fasting condition. There is no evidence of dose dumping in the presence or absence of food.

Effect of Alcohol

An in vitrostudy was conducted to explore the effect of alcohol on the release characteristics of methylphenidate from the methylphenidate hydrochloride extended-release capsules (LA) 40 mg dosage form. At an alcohol concentration of 40% there was a 98% release of methylphenidate in the first hour. The results with the 40 mg capsule are considered to be representative of the other available capsule strengths.

Distribution

Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ± 1.11 L/kg for d- methylphenidate and 1.80 ± 0.91 L/kg for l-methylphenidate.

Elimination

The systemic clearance is 0.40 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate. In studies with methylphenidate hydrochloride extended-release capsules (LA) and methylphenidate hydrochloride tablets in adults, methylphenidate from methylphenidate hydrochloride tablets is eliminated from plasma with an average half-life of about 3.5 hours, (range, 1.3 to 7.7 hours). In children the average half-life is about 2.5 hours, with a range of about 1.5 to 5.0 hours. The rapid half-life in both children and adults may result in un-measurable concentrations between the morning and mid-day doses with methylphenidate hydrochloride tablets. No accumulation of methylphenidate is expected following multiple once a day oral dosing with methylphenidate hydrochloride extended-release capsules (LA). The half-life of ritalinic acid is about 3 to 4 hours.

Metabolism

The absolute oral bioavailability of methylphenidate in children was 22 ± 8% for d-methylphenidate and 5 ± 3% for l- methylphenidate, suggesting pronounced presystemic metabolism. Biotransformation of methylphenidate by the carboxylesterase CES1A1 is rapid and extensive leading to the main, de-esterified metabolite α-phenyl-2-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity. Only small amounts of hydroxylated metabolites (e.g., hydroxymethylphenidate and hydroxyritalinic acid) are detectable in plasma. Therapeutic activity is principally due to the parent compound.

Excretion

After oral administration of an immediate release formulation of methylphenidate, 78% to 97% of the dose is excreted in the urine and 1% to 3% in the feces in the form of metabolites within 48 to 96 hours. Only small quantities (less than 1%) of unchanged methylphenidate appear in the urine. Most of the dose is excreted in the urine as ritalinic acid (60% to 86%), the remainder being accounted for by minor metabolite.

Studies in Specific Populations

Male and Female Patients

There were no apparent gender differences in the pharmacokinetics of methylphenidate between healthy male and female adults when administered methylphenidate hydrochloride extended-release capsules (LA).

Racial or Ethnic Groups

There is insufficient experience with the use of methylphenidate hydrochloride extended-release capsules (LA) to detect ethnic variations in pharmacokinetics.

Pediatric Patients

The pharmacokinetics of methylphenidate hydrochloride extended-release capsules (LA) was examined in 18 children with ADHD between 7 and 12 years of age. Fifteen of these children were between 10 and 12 years of age. The time until the between peak minimum, and the time until the second peak were delayed and more variable in children compared to adults. After a 20-mg dose of methylphenidate hydrochloride extended-release capsules (LA), concentrations in children were approximately twice the concentrations observed in 18 to 35 year old adults. This higher exposure is almost completely due to the smaller body size and total volume of distribution in children, as apparent clearance normalized to body weight is independent of age.

Patients with Renal Impairment

Methylphenidate hydrochloride extended-release capsules (LA) has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity.

Patients with Hepatic Impairment

Methylphenidate hydrochloride extended-release capsules (LA) has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.

Carcinogenesis

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the (MRHD) of 60 mg/day given to children on a mg/m 2basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) on a mg/m 2basis.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate.

Mutagenesis

Methylphenidate was not mutagenic in the in vitroAmes reverse mutation assay, in the in vitromouse lymphoma cell forward mutation assay, or in the in vitrochromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitroassay in cultured Chinese Hamster Ovary cells. Methylphenidate was negative in vivoin males and females in the mouse bone marrow micronucleus assay.

Impairment of Fertility

Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10 times the maximum recommended dose of 60 mg/day given to adolescents on a mg/m 2basis.

Methylphenidate hydrochloride extended-release capsules (LA) was evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12, with DSM-IV diagnoses of ADHD received a single morning dose of methylphenidate hydrochloride extended-release capsules (LA)in the range of 10 to 40 mg/day, or placebo, for up to 2 weeks. The doses used were the optimal doses established in a previous individual dose titration phase. In that titration phase, 53 of 164 patients (32%) started on a daily dose of 10 mg and 111 of 164 patients (68%) started on a daily dose of 20 mg or higher. The patient's regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter. Patients treated with methylphenidate hydrochloride extended-release capsules (LA) showed a statistically significant improvement in symptom scores from baseline [Mean (final score - baseline) = -10.7 points)] over patients who received placebo [Mean (final score - baseline) = +2.8 points ]. The lower the final score on the CADS-T scale from baseline, the less severe the disease is. This demonstrates that a single morning dose of methylphenidate hydrochloride extended-release capsules (LA) exerts a treatment effect in ADHD.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">Figure 2: CADS-T Total Subscale - Mean Change From Baseline*</span></td> </tr> <tr> <td align="center"><img alt="Principal Display Panel" src="/dailymed/image.cfm?name=methylphenidate-03.jpg&amp;setid=e5db854a-1c77-4faf-9e60-daf9c9b6cfa0"/></td> </tr> </tbody> </table></div>

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F and 86°F). [See USP controlled room temperature].

Dispense in tight container (USP).

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (LA) by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules (LA) with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard methylphenidate hydrochloride extended-release capsules (LA) in the household trash.

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients that methylphenidate hydrochloride extended-release capsules (LA) is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride extended-release capsules (LA) to anyone else. Advise patients to store methylphenidate hydrochloride extended-release capsules (LA) in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (LA) by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1, 9.2, 9.3), How Supplied/Storage and Handling (16)] .

Serious Cardiovascular Risks

Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with methylphenidate hydrochloride extended-release capsules (LA) use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that methylphenidate hydrochloride extended-release capsules (LA) can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions (5.3)] .

Psychiatric Risks

Advise patients that methylphenidate hydrochloride extended-release capsules (LA), at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Priapism

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)] .

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud's Phenomenon]

Instruct patients beginning treatment with methylphenidate hydrochloride extended-release capsules (LA) about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release capsules (LA). Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)] .

Suppression of Growth

Advise patients that methylphenidate hydrochloride extended-release capsules (LA) may cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].

Alcohol Effect

Advise patients to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules (LA). Consumption of alcohol while taking methylphenidate hydrochloride extended-release capsules (LA) may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3)] .

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride extended-release capsules (LA) during pregnancy [see Use in Specific Populations (8.1)] .

Distributed by: Mayne Pharma Raleigh, NC 27609

{ "type": "p", "children": [], "text": "Distributed by: \n \nMayne Pharma\n Raleigh, NC 27609\n\n " }

AB7678

{ "type": "p", "children": [], "text": "AB7678" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="20%"/> <col align="left" valign="top" width="20%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" colspan="5">MEDICATION GUIDE <br/> Methylphenidate Hydrochloride (METH-il-FEN-i-date HYE-droe-KLOR-ide) <br/> Extended-Release Capsules (LA) CII </th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="4">This Medication Guide has been approved by the U.S. Food and Drug Administration.</td><td align="right" colspan="1">Revised: 11/2022</td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (LA)? <br/> Methylphenidate hydrochloride extended-release capsules (LA) is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules (LA) in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules (LA) may harm others, and is against the law. </span>Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. <br/> <span class="Bold">The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.</span> <br/> <span class="Bold">1. <span class="Underline">Heart-related problems</span>: </span> <ul class="Disc"> <li> <span class="Bold">sudden death in patients who have heart problems or heart defects</span> </li> <li> <span class="Bold">stroke and heart attack in adults</span> </li> <li> <span class="Bold">increased blood pressure and heart rate</span> </li> </ul>Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. <br/> Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride extended-release capsules (LA). <br/> Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules (LA). <br/> <span class="Bold">Call your doctor right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride extended-release capsules (LA).</span> <br/> <span class="Bold">2. <span class="Underline">Mental (psychiatric) problems</span>: </span> <br/> <span class="Bold">All Patients</span> <ul class="Disc"> <li> <span class="Bold">new or worse behavior and thought problems</span> </li> <li> <span class="Bold">new or worse bipolar illness</span> </li> <li> <span class="Bold">new or worse aggressive behavior or hostility</span> </li> <li> <span class="Bold">new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms</span> </li> </ul>Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. <br/> <span class="Bold">Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride extended-release capsules (LA), especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">What are methylphenidate hydrochloride extended-release capsules (LA)?</span> <br/> Methylphenidate hydrochloride extended-release capsules (LA) are a central nervous system (CNS) stimulant prescription medicine. <span class="Bold">It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).</span>Methylphenidate hydrochloride extended-release capsules (LA) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. <br/> Methylphenidate hydrochloride extended-release capsules (LA) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. <br/> <span class="Bold">It is not known if methylphenidate hydrochloride extended-release capsules (LA) is safe and effective in children under 6 years of age.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">Who should not take methylphenidate hydrochloride extended-release capsules (LA)? <br/> Methylphenidate hydrochloride extended-release capsules (LA) should not be taken if you or your child: </span> <ul class="Disc"> <li>are allergic to methylphenidate hydrochloride, or any of the ingredients in methylphenidate hydrochloride extended-release capsules (LA). See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride extended-release capsules (LA).</li> <li>are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).</li> </ul> <span class="Bold">Methylphenidate hydrochloride extended-release capsules (LA) may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules (LA) tell your or your child's doctor about all health conditions (or a family history of), including:</span> <ul class="Disc"> <li>heart problems, heart defects, high blood pressure</li> <li>mental problems including psychosis, mania, bipolar illness, or depression</li> <li>circulation problems in fingers or toes</li> <li>if you are pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride extended-release capsules (LA) will harm your unborn baby. <ul class="Circle"> <li>There is a pregnancy registry for females who are exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules (LA) during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride extended-release capsules (LA) and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release capsules (LA), talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.</li> </ul> </li> <li>if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride extended-release capsules (LA) passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release capsules (LA).</li> </ul> <span class="Bold">Tell your doctor about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</span>Methylphenidate hydrochloride extended-release capsules (LA) and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate hydrochloride extended-release capsules (LA). <br/> Your doctor will decide whether methylphenidate hydrochloride extended-release capsules (LA) can be taken with other medicines. <br/> <span class="Bold">Especially tell your doctor if you or your child takes:</span> <ul class="Disc"> <li>anti-depression medicines, including MAOIs</li> <li>blood pressure medicines (anti-hypertensive)</li> <li>risperidone</li> </ul>Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. <ul class="Disc"> <li>You should not take methylphenidate hydrochloride extended-release capsules (LA) on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.</li> </ul> <span class="Bold">Do not start any new medicine while taking methylphenidate hydrochloride extended-release capsules (LA) without talking to your doctor first.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">How should methylphenidate hydrochloride extended-release capsules (LA) be taken?</span> <ul class="Disc"> <li>Take methylphenidate hydrochloride extended-release capsules (LA) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.</li> <li>Take methylphenidate hydrochloride extended-release capsules (LA) once a day in the morning. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release capsule.</li> <li> <span class="Bold">Do not chew or crush methylphenidate hydrochloride extended-release capsules (LA) or the medicine inside the capsule.</span>Swallow methylphenidate hydrochloride extended-release capsules (LA) whole with water or other liquids. </li> <li>If you cannot swallow the capsule whole, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid.</li> <li>You should avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules (LA) <span class="Bold">.</span>This may cause a faster release of methylphenidate hydrochloride extended-release capsules (LA). </li> <li>From time-to-time, your doctor may stop methylphenidate hydrochloride extended-release capsules (LA) treatment for a while to check ADHD symptoms.</li> <li>Your doctor may do regular checks of the blood, heart, and blood pressure while taking methylphenidate hydrochloride extended-release capsules (LA). Children should have their height and weight checked often while taking methylphenidate hydrochloride extended-release capsules (LA). Methylphenidate hydrochloride extended-release capsules (LA) treatment may be stopped if a problem is found during these check-ups.</li> </ul> <span class="Bold">In case of poisoning, call your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">What are possible side effects of methylphenidate hydrochloride extended-release capsules (LA)?</span> <ul class="Disc"> <li>see <span class="Bold">" <a href="#Important">What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (LA)?</a>" </span>for information on reported heart and mental problems. </li> <li> <span class="Bold">painful and prolonged erections (priapism)</span>have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately. </li> <li> <span class="Bold">circulation problems in fingers and toes</span>(peripheral vasculopathy, including Raynaud's Phenomenon): <ul class="Circle"> <li>fingers or toes may feel numb, cool, painful</li> <li>fingers or toes may change color from pale, to blue, to red</li> </ul> </li> </ul>Tell your doctor if you or your child have numbness, pain, skin discoloration, or sensitivity to temperature in the fingers or toes. <ul class="Disc"> <li> <span class="Bold">Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release capsules (LA).</span> </li> <li> <span class="Bold">Slowing of growth (height and weight) in children</span> </li> </ul> <span class="Bold">Common side effects include:</span></td> </tr> <tr> <td align="left" class="Lrule"> <ul class="Disc"> <li>fast heart beat</li> <li>sweating a lot</li> </ul> </td><td align="left"> <ul class="Disc"> <li>Abnormal heartbeat (palpitations)</li> <li>Decreased appetite</li> </ul> </td><td align="left"> <ul class="Disc"> <li>headache</li> <li>dry mouth</li> </ul> </td><td align="left"> <ul class="Disc"> <li>trouble sleeping</li> <li>nausea</li> </ul> </td><td align="left" class="Rrule"> <ul class="Disc"> <li>nervousness</li> <li>stomach pain</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">How should I store methylphenidate hydrochloride extended-release capsules (LA)?</span> <ul class="Disc"> <li>Store methylphenidate hydrochloride extended-release capsules (LA) in a safe place and in a tightly closed container at room temperature, 68°F to 77°F (20°C to 25°C).</li> <li>Protect from moisture.</li> <li>Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (LA) by a medicine take-back program at authorized collection sites, such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules (LA) with an undesirable, nontoxic substance, such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away (discard) methylphenidate hydrochloride extended-release capsules (LA) in the household trash.</li> <li> <span class="Bold">Keep methylphenidate hydrochloride extended-release capsules (LA) and all medicines out of the reach of children.</span> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">General information about the safe and effective use methylphenidate hydrochloride extended-release capsules (LA).</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about <span class="Bold">methylphenidate hydrochloride extended-release capsules (LA)</span>that is written for healthcare professionals. Do not use methylphenidate extended release-capsules (LA) for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (LA) to other people, even if they have the same symptoms. It may harm them and it is against the law. </td> </tr> <tr> <td align="left"></td><td align="left"></td><td align="left"></td><td align="left"></td><td align="left"></td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule" colspan="5"><span class="Bold">What are the ingredients in methylphenidate hydrochloride extended-release capsules (LA)? <br/> Active Ingredient: </span>methylphenidate HCl <br/> <span class="Bold">Inactive Ingredients:</span>sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&amp;C Green#3, FD&amp;C #40, and FD&amp;C Yellow #6. The 30 and 40 mg capsules contain D&amp;C Red #28 and FD&amp;C Blue #1. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol. <br/> Distributed by: <br/> <span class="Bold">Mayne Pharma</span> <br/> Raleigh, NC 27609 <br/> AB7678 <br/> <span class="Bold">For more information, call 1-844-825-8500.</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<col align=\"left\" valign=\"top\" width=\"20%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"5\">MEDICATION GUIDE \n <br/> Methylphenidate Hydrochloride (METH-il-FEN-i-date HYE-droe-KLOR-ide) \n <br/> Extended-Release Capsules (LA) CII\n </th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"4\">This Medication Guide has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\" colspan=\"1\">Revised: 11/2022</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (LA)? \n <br/> Methylphenidate hydrochloride extended-release capsules (LA) is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules (LA) in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules (LA) may harm others, and is against the law.\n </span>Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. \n <br/>\n<span class=\"Bold\">The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.</span>\n<br/>\n<span class=\"Bold\">1.\n \n <span class=\"Underline\">Heart-related problems</span>:\n \n </span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">sudden death in patients who have heart problems or heart defects</span>\n</li>\n<li>\n<span class=\"Bold\">stroke and heart attack in adults</span>\n</li>\n<li>\n<span class=\"Bold\">increased blood pressure and heart rate</span>\n</li>\n</ul>Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. \n <br/> Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride extended-release capsules (LA). \n <br/> Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules (LA). \n <br/>\n<span class=\"Bold\">Call your doctor right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride extended-release capsules (LA).</span>\n<br/>\n<span class=\"Bold\">2.\n \n <span class=\"Underline\">Mental (psychiatric) problems</span>:\n \n </span>\n<br/>\n<span class=\"Bold\">All Patients</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">new or worse behavior and thought problems</span>\n</li>\n<li>\n<span class=\"Bold\">new or worse bipolar illness</span>\n</li>\n<li>\n<span class=\"Bold\">new or worse aggressive behavior or hostility</span>\n</li>\n<li>\n<span class=\"Bold\">new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms</span>\n</li>\n</ul>Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. \n <br/>\n<span class=\"Bold\">Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride extended-release capsules (LA), especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">What are methylphenidate hydrochloride extended-release capsules (LA)?</span>\n<br/> Methylphenidate hydrochloride extended-release capsules (LA) are a central nervous system (CNS) stimulant prescription medicine.\n \n <span class=\"Bold\">It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).</span>Methylphenidate hydrochloride extended-release capsules (LA) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. \n <br/> Methylphenidate hydrochloride extended-release capsules (LA) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. \n <br/>\n<span class=\"Bold\">It is not known if methylphenidate hydrochloride extended-release capsules (LA) is safe and effective in children under 6 years of age.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">Who should not take methylphenidate hydrochloride extended-release capsules (LA)? \n <br/> Methylphenidate hydrochloride extended-release capsules (LA) should not be taken if you or your child:\n </span>\n<ul class=\"Disc\">\n<li>are allergic to methylphenidate hydrochloride, or any of the ingredients in methylphenidate hydrochloride extended-release capsules (LA). See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride extended-release capsules (LA).</li>\n<li>are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).</li>\n</ul>\n<span class=\"Bold\">Methylphenidate hydrochloride extended-release capsules (LA) may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules (LA) tell your or your child's doctor about all health conditions (or a family history of), including:</span>\n<ul class=\"Disc\">\n<li>heart problems, heart defects, high blood pressure</li>\n<li>mental problems including psychosis, mania, bipolar illness, or depression</li>\n<li>circulation problems in fingers or toes</li>\n<li>if you are pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride extended-release capsules (LA) will harm your unborn baby.\n \n <ul class=\"Circle\">\n<li>There is a pregnancy registry for females who are exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules (LA) during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride extended-release capsules (LA) and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release capsules (LA), talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.</li>\n</ul>\n</li>\n<li>if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride extended-release capsules (LA) passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release capsules (LA).</li>\n</ul>\n<span class=\"Bold\">Tell your doctor about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</span>Methylphenidate hydrochloride extended-release capsules (LA) and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate hydrochloride extended-release capsules (LA). \n <br/> Your doctor will decide whether methylphenidate hydrochloride extended-release capsules (LA) can be taken with other medicines. \n <br/>\n<span class=\"Bold\">Especially tell your doctor if you or your child takes:</span>\n<ul class=\"Disc\">\n<li>anti-depression medicines, including MAOIs</li>\n<li>blood pressure medicines (anti-hypertensive)</li>\n<li>risperidone</li>\n</ul>Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.\n \n <ul class=\"Disc\">\n<li>You should not take methylphenidate hydrochloride extended-release capsules (LA) on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.</li>\n</ul>\n<span class=\"Bold\">Do not start any new medicine while taking methylphenidate hydrochloride extended-release capsules (LA) without talking to your doctor first.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">How should methylphenidate hydrochloride extended-release capsules (LA) be taken?</span>\n<ul class=\"Disc\">\n<li>Take methylphenidate hydrochloride extended-release capsules (LA) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.</li>\n<li>Take methylphenidate hydrochloride extended-release capsules (LA) once a day in the morning. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release capsule.</li>\n<li>\n<span class=\"Bold\">Do not chew or crush methylphenidate hydrochloride extended-release capsules (LA) or the medicine inside the capsule.</span>Swallow methylphenidate hydrochloride extended-release capsules (LA) whole with water or other liquids.\n \n </li>\n<li>If you cannot swallow the capsule whole, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid.</li>\n<li>You should avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules (LA)\n \n <span class=\"Bold\">.</span>This may cause a faster release of methylphenidate hydrochloride extended-release capsules (LA).\n \n </li>\n<li>From time-to-time, your doctor may stop methylphenidate hydrochloride extended-release capsules (LA) treatment for a while to check ADHD symptoms.</li>\n<li>Your doctor may do regular checks of the blood, heart, and blood pressure while taking methylphenidate hydrochloride extended-release capsules (LA). Children should have their height and weight checked often while taking methylphenidate hydrochloride extended-release capsules (LA). Methylphenidate hydrochloride extended-release capsules (LA) treatment may be stopped if a problem is found during these check-ups.</li>\n</ul>\n<span class=\"Bold\">In case of poisoning, call your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">What are possible side effects of methylphenidate hydrochloride extended-release capsules (LA)?</span>\n<ul class=\"Disc\">\n<li>see\n \n <span class=\"Bold\">\"\n \n <a href=\"#Important\">What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (LA)?</a>\"\n \n </span>for information on reported heart and mental problems.\n \n </li>\n<li>\n<span class=\"Bold\">painful and prolonged erections (priapism)</span>have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.\n \n </li>\n<li>\n<span class=\"Bold\">circulation problems in fingers and toes</span>(peripheral vasculopathy, including Raynaud's Phenomenon):\n \n <ul class=\"Circle\">\n<li>fingers or toes may feel numb, cool, painful</li>\n<li>fingers or toes may change color from pale, to blue, to red</li>\n</ul>\n</li>\n</ul>Tell your doctor if you or your child have numbness, pain, skin discoloration, or sensitivity to temperature in the fingers or toes.\n \n <ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release capsules (LA).</span>\n</li>\n<li>\n<span class=\"Bold\">Slowing of growth (height and weight) in children</span>\n</li>\n</ul>\n<span class=\"Bold\">Common side effects include:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Disc\">\n<li>fast heart beat</li>\n<li>sweating a lot</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>Abnormal heartbeat (palpitations)</li>\n<li>Decreased appetite</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>headache</li>\n<li>dry mouth</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>trouble sleeping</li>\n<li>nausea</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\">\n<ul class=\"Disc\">\n<li>nervousness</li>\n<li>stomach pain</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">How should I store methylphenidate hydrochloride extended-release capsules (LA)?</span>\n<ul class=\"Disc\">\n<li>Store methylphenidate hydrochloride extended-release capsules (LA) in a safe place and in a tightly closed container at room temperature, 68°F to 77°F (20°C to 25°C).</li>\n<li>Protect from moisture.</li>\n<li>Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (LA) by a medicine take-back program at authorized collection sites, such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules (LA) with an undesirable, nontoxic substance, such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away (discard) methylphenidate hydrochloride extended-release capsules (LA) in the household trash.</li>\n<li>\n<span class=\"Bold\">Keep methylphenidate hydrochloride extended-release capsules (LA) and all medicines out of the reach of children.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">General information about the safe and effective use methylphenidate hydrochloride extended-release capsules (LA).</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about\n \n <span class=\"Bold\">methylphenidate hydrochloride extended-release capsules (LA)</span>that is written for healthcare professionals. Do not use methylphenidate extended release-capsules (LA) for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (LA) to other people, even if they have the same symptoms. It may harm them and it is against the law.\n \n </td>\n</tr>\n<tr>\n<td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td><td align=\"left\"></td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"5\"><span class=\"Bold\">What are the ingredients in methylphenidate hydrochloride extended-release capsules (LA)? \n <br/> Active Ingredient:\n </span>methylphenidate HCl \n <br/>\n<span class=\"Bold\">Inactive Ingredients:</span>sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&amp;C Green#3, FD&amp;C #40, and FD&amp;C Yellow #6. The 30 and 40 mg capsules contain D&amp;C Red #28 and FD&amp;C Blue #1. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol. \n <br/> Distributed by: \n <br/>\n<span class=\"Bold\">Mayne Pharma</span>\n<br/> Raleigh, NC 27609 \n <br/> AB7678 \n <br/>\n<span class=\"Bold\">For more information, call 1-844-825-8500.</span></td>\n</tr>\n</tbody>\n</table></div>" }

NDC 51862-614-30

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Once Daily Methylphenidate Hydrochloride

{ "type": "p", "children": [], "text": "Once Daily \n Methylphenidate \n Hydrochloride\n " }

CII

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Extended-Release Capsules (LA)

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60 mg

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PHARMACIST: Please dispense with Medication Guide provided separately.

{ "type": "p", "children": [], "text": "PHARMACIST: Please dispense with \n Medication Guide provided separately.\n " }

Rx Only 30 Capsules

{ "type": "p", "children": [], "text": "Rx Only \n 30 Capsules\n " }

maynepharma

{ "type": "p", "children": [], "text": "maynepharma" }

NDC 51862-609-01

{ "type": "p", "children": [], "text": "NDC 51862-609-01" }

Once Daily Methylphenidate Hydrochloride

{ "type": "p", "children": [], "text": "Once Daily \n Methylphenidate \n Hydrochloride\n " }

CII

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Extended-Release Capsules (LA)

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10 mg

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PHARMACIST: Please dispense with Medication Guide provided separately.

{ "type": "p", "children": [], "text": "PHARMACIST: Please dispense with \n Medication Guide provided separately.\n " }

Rx Only 100 Capsules

{ "type": "p", "children": [], "text": "Rx Only \n 100 Capsules\n " }

maynepharma

{ "type": "p", "children": [], "text": "maynepharma" }

NDC 51862-610-01

{ "type": "p", "children": [], "text": "NDC 51862-610-01" }

Once Daily Methylphenidate Hydrochloride

{ "type": "p", "children": [], "text": "Once Daily \n Methylphenidate \n Hydrochloride\n " }

CII

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Extended-Release Capsules (LA)

{ "type": "p", "children": [], "text": "Extended-Release Capsules (LA)" }

20 mg

{ "type": "p", "children": [], "text": "20 mg" }

PHARMACIST: Please dispense with Medication Guide provided separately.

{ "type": "p", "children": [], "text": "PHARMACIST: Please dispense with \n Medication Guide provided separately.\n " }

Rx Only 100 Capsules

{ "type": "p", "children": [], "text": "Rx Only \n 100 Capsules\n " }

maynepharma

{ "type": "p", "children": [], "text": "maynepharma" }

NDC 51862-611-01

{ "type": "p", "children": [], "text": "NDC 51862-611-01" }

Once Daily Methylphenidate Hydrochloride

{ "type": "p", "children": [], "text": "Once Daily \n Methylphenidate \n Hydrochloride\n " }

CII

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Extended-Release Capsules (LA)

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30 mg

{ "type": "p", "children": [], "text": "30 mg" }

PHARMACIST: Please dispense with Medication Guide provided separately.

{ "type": "p", "children": [], "text": "PHARMACIST: Please dispense with \n Medication Guide provided separately.\n " }

Rx Only 100 Capsules

{ "type": "p", "children": [], "text": "Rx Only \n 100 Capsules\n " }

maynepharma

{ "type": "p", "children": [], "text": "maynepharma" }

NDC 51862-612-01

{ "type": "p", "children": [], "text": "NDC 51862-612-01" }

Once Daily Methylphenidate Hydrochloride

{ "type": "p", "children": [], "text": "Once Daily \n Methylphenidate \n Hydrochloride\n " }

CII

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Extended-Release Capsules (LA)

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40 mg

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PHARMACIST: Please dispense with Medication Guide provided separately.

{ "type": "p", "children": [], "text": "PHARMACIST: Please dispense with \n Medication Guide provided separately.\n " }

Rx Only 100 Capsules

{ "type": "p", "children": [], "text": "Rx Only \n 100 Capsules\n " }

maynepharma

{ "type": "p", "children": [], "text": "maynepharma" }

QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].

{ "type": "p", "children": [], "text": "QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].\n" }

Prior to treating patients with QUILLIVANT XR, assess:

QUILLIVANT XR should be orally administered once daily in the morning with or without food [see Clinical Pharmacology (12.3)].

If switching from other methylphenidate products, discontinue that treatment, and titrate with QUILLIVANT XR using the above titration schedule.

Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)].

QUILLIVANT XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing. Preparation instructions: Tap bottle until powder flows freely. Remove bottle cap, and add specified amount of water to the bottle (see Table 1 below). Fully insert bottle adapter into neck of bottle [see Instructions for Use, Figures F and G]. Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension.

<div class="scrollingtable"><table> <caption> <span>Table 1: Product Reconstitution Instructions</span> </caption> <col width="123"/> <col width="123"/> <col width="123"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Amount of drug in bottle</span></td><td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Amount of water to add to bottle</span></td><td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Final reconstituted volume (yield)</span></td> </tr> <tr> <td align="center" class="Lrule Rrule Toprule" valign="bottom">300 mg</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">53 mL</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">60 mL</td> </tr> <tr> <td align="center" class="Lrule Rrule Toprule" valign="bottom">600 mg</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">105 mL</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">120 mL</td> </tr> <tr> <td align="center" class="Lrule Rrule Toprule" valign="bottom">750 mg</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">131 mL</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">150 mL</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule Toprule" valign="bottom">900 mg</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">158 mL</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">180 mL</td> </tr> </tbody> </table></div>

Store reconstituted QUILLIVANT XR at 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF). Dispense in original packaging (bottle in carton) with bottle adapter inserted and with enclosed oral dosing dispenser. QUILLIVANT XR is stable for up to 4 months after reconstitution.

Extended-release oral suspension (after reconstitution with water): 25 mg per 5 mL (5 mg per mL).

{ "type": "p", "children": [], "text": "Extended-release oral suspension (after reconstitution with water): 25 mg per 5 mL (5 mg per mL)." }

QUILLIVANT XR is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QUILLIVANT XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6.2)].

QUILLIVANT XR is contraindicated during treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of hypertensive crisis [see Drug Interactions (7.1)].

Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Avoid QUILLIVANT XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases.

Monitor all QUILLIVANT XR-treated patients for hypertension and tachycardia.

Exacerbation of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating QUILLIVANT XR treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 % of placebo-treated patients. If such symptoms occur, consider discontinuing QUILLIVANT XR.

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adults and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during a methylphenidate withdrawal (drug holidays or during discontinuation).

QUILLIVANT XR-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

CNS stimulants, including QUILLIVANT XR, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.

Careful observation of digital changes is necessary during QUILLIVANT XR treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for QUILLIVANT XR-treated patients who develop signs or symptoms of peripheral vasculopathy.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or nonmedication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.

Closely monitor growth (weight and height) in QUILLIVANT XR-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, QUILLIVANT XR -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)].

Prescribe QUILLIVANT XR to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor QUILLIVANT XR -treated patients with a history of abnormally increased IOP or open angle glaucoma.

CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating QUILLIVANT XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor QUILLIVANT XR -treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions in Studies with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD

Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Adverse Reactions in Studies with QUILLIVANT XR in Children and Adolescents with ADHD

There is limited experience with QUILLIVANT XR in controlled trials. Based on this limited experience, the adverse reaction profile of QUILLIVANT XR appears similar to other methylphenidate extended-release products. The most common (≥2% in the QUILLIVANT XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) were affect lability, excoriation, initial insomnia, tic, decreased appetite, vomiting, motion sickness, eye pain, and rash.

<div class="scrollingtable"><table> <caption> <span>Table 2: Common Adverse Reactions occurring in ≥2% of subjects on QUILLIVANT XR and greater than placebo during the controlled cross-over phase</span> </caption> <col width="123"/> <col width="207"/> <col width="222"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule"><span class="Bold">Adverse reaction</span></td><td align="center" class="Lrule Rrule Toprule"><span class="Bold">QUILLIVANT XR</span> <br/> <span class="Bold">N= 45</span></td><td align="center" class="Lrule Rrule Toprule"><span class="Bold">Placebo</span> <br/> <span class="Bold">N= 45</span></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Affect lability</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">9%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Excoriation</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">4%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Initial Insomnia</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Tic </td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Decreased appetite </td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Vomiting</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Motion sickness</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom">Eye pain</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> <tr class="Last"> <td class="Lrule Rrule Toprule" valign="bottom">Rash</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">2%</td><td align="center" class="Lrule Rrule Toprule" valign="bottom">0</td> </tr> </tbody> </table></div>

The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris, Bradycardia, Extra systole, Supraventricular tachycardia, Ventricular extra systole

Eye Disorders: Diplopia, Increased intraocular pressure, Mydriasis, Visual impairment

General Disorders: Chest pain, Chest discomfort, Hyperpyrexia

Hepatobiliary Disorders: Severe hepatocellular injury

Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes, Eruptions, and Exanthemas NEC

Investigations: Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal

Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs, Motor and Verbal Tics  

Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania

Urogenital System: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Vascular Disorders: Raynaud’s phenomenon

MAOI Inhibitors Do not administer QUILLIVANT XR concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment. Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.

Antihypertensive Drugs QUILLIVANT XR may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the hypertensive drug as needed [see Warnings and Precautions (5.3)]. Halogenated Anesthetics Concomitant use of halogenated anesthetics and QUILLIVANT XR may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of QUILLIVANT XR in patients being treated with anesthetics on the day of surgery. Risperidone

Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.

Risk Summary

There are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks. There are clinical considerations [see Clinical Considerations]. No teratogenic effects were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses 2 and 11 times, respectively, the maximum recommended human dose (MRHD). However, spina bifida was observed in rabbits at a dose 40 times the MRHD [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal adverse reactions

CNS stimulant medications, such as QUILLIVANT XR, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data

Animal Data

In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m2 basis).

Risk Summary

Limited published literature reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from CNS stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QUILLIVANT XR and any potential adverse effects on the breastfed infant from QUILLIVANT XR or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

The safety and effectiveness of QUILLIVANT XR have been established in pediatric patients ages 6 to 17 years. Use of QUILLIVANT XR in pediatric patients 6 to 12 years of age is supported by one adequate and well-controlled study [see Clinical Studies (14)]. Use in 12 to 17 year old’s is supported by the adequate and well-controlled studies of QUILLIVANT XR in younger pediatric patients and additional pharmacokinetic data in adolescents, along with safety information from other methylphenidate‑containing products. The safety and effectiveness of QUILLIVANT XR in pediatric patients less than 6 years have not been established.

The long-term efficacy of methylphenidate in pediatric patients has not been established.

Long Term Suppression of Growth

Growth should be monitored during treatment with CNS stimulants, including QUILLIVANT XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)].

Juvenile Animal Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 6 times the maximum recommended human dose (MRHD) on a mg/m2 basis.

In the study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). When these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was observed in females exposed to the highest dose (12 times the MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

QUILLIVANT XR has not been studied in patients over the age of 65 years.

QUILLIVANT XR contains methylphenidate, a Schedule II controlled substance.

QUILLIVANT XR has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)]. QUILLIVANT XR can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including QUILLIVANT XR, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Physical Dependence

QUILLIVANT XR may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including QUILLIVANT XR include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance

QUILLIVANT XR may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Clinical Effects of Overdose

{ "type": "p", "children": [], "text": "\nClinical Effects of Overdose\n" }

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

{ "type": "p", "children": [], "text": "Overdose of CNS stimulants is characterized by the following sympathomimetic effects:" }

{ "type": "ul", "children": [ "Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.", "CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.", "Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop." ], "text": "" }

Overdose Management

{ "type": "p", "children": [], "text": "\nOverdose Management\n" }

Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of QUILLIVANT XR should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

{ "type": "p", "children": [], "text": "Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of QUILLIVANT XR should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations." }

QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR is available in a 25 mg per 5 mL (5 mg per mL) extended-release oral suspension.

{ "type": "p", "children": [], "text": "QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR is available in a 25 mg per 5 mL (5 mg per mL) extended-release oral suspension." }

Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1.

{ "type": "p", "children": [], "text": "Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1." }

Figure 1: Methylphenidate HCl structure

{ "type": "p", "children": [], "text": "\nFigure 1: Methylphenidate HCl structure\n" }

C14H19NO2•HCI       Mol. Wt. 269.77

{ "type": "p", "children": [], "text": "C14H19NO2•HCI       Mol. Wt. 269.77" }

Methylphenidate HCl is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.

{ "type": "p", "children": [], "text": "Methylphenidate HCl is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone." }

QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.

{ "type": "p", "children": [], "text": "QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide." }

Methylphenidate HCl is a central nervous system (CNS) stimulant.

Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l‑isomer. The mode of therapeutic action in ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Absorption

Following a single, 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects in a crossover study under fasting conditions, d-methylphenidate (d-MPH) mean (± SD) peak plasma concentrations of 13.6 (± 5.8) ng/mL occurred at a median time of 5 hours after dosing (Figure 2). The relative bioavailability of QUILLIVANT XR compared to Methylphenidate IR oral solution (2x30 mg, q6h) is 95%.

Figure 2: Mean d-Methylphenidate Plasma Concentration-Time Profiles

The single dose pharmacokinetics of d-MPH under fed conditions are summarized (Table 3) from studies in children and adolescents with ADHD, and healthy adults following an oral dose of 60 mg QUILLIVANT XR.

<div class="scrollingtable"><table> <caption> <span>Table 3: d-MPH PK Parameters (mean ±SD) after 60 mg oral dosing of QUILLIVANT XR*</span> </caption> <col width="156"/> <col width="120"/> <col width="138"/> <col width="108"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">PK Parameter</span></td><td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Children† (n=3)</span></td><td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Adolescent† (n=4)</span></td><td align="center" class="Lrule Rrule Toprule" valign="bottom"><span class="Bold">Adult (n=27)</span></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">T</span><span class="Sub">max </span><span class="Underline">(hr)</span><span class="Underline"><span class="Sup">‡</span></span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">4.05 (3.98-6.0)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">2.0 (1.98-4.0)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">4.0 (1.3-7.3)</span></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">T</span><span class="Sub">1/2 </span><span class="Underline">(hr)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">5.2±0.1</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">5.0±0.2</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">5.2±1.0</span></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">C</span><span class="Sub">max</span> <span class="Underline">(ng/mL)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">34.4±14.0 </span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">21.1±5.9</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">17.0±7.7</span></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">AUC</span><span class="Sub">inf</span> <span class="Underline">(hr*ng/mL)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">378±175</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">178±54.2</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">163.2±80.3</span></td> </tr> <tr class="Last"> <td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">Cl (L/hr/kg)</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">4.27±0.70</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">5.06±1.42</span></td><td class="Lrule Rrule Toprule" valign="bottom"><span class="Underline">5.66±2.15</span></td> </tr> </tbody> </table></div>

* Breakfast was given 30 min prior to drug administration† total MPH measured in children (9 to 12 years old) and adolescents (13 to 15 years old), l-MPH <2% of d-MPH in circulation‡ data presented as median (range)

Food Effects

In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of QUILLIVANT XR at a dose of 60 mg, the presence of food reduced the time to peak concentration by approximately 1 hour (fed: 4 hours vs. fasted: 5 hours). Overall, a high-fat meal increased the average Cmax of QUILLIVANT XR by about 28% and the AUC by about 19%. These changes are not considered clinically significant.

Elimination

Following a single 60 mg oral dose of QUILLIVANT XR in 28 healthy adult subjects under fasting conditions, the mean plasma terminal elimination half-life of d-methylphenidate was 5.6 (± 0.8) hours.

Metabolism

In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenyl-piperidine acetic acid (PPAA). The metabolite has little or no pharmacologic activity.

Excretion

After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPAA, accounting for approximately 80% of the dose.

Alcohol Effect

An in vitro study was conducted to explore the effect of alcohol on the release characteristics of methylphenidate from QUILLIVANT XR Oral Suspension. At alcohol concentrations of 5% and 10%, there was no effect of alcohol on the release characteristics of methylphenidate. At 20% alcohol concentration, there was on average a 20% increase in drug exposure [see Dosage and Administration (2.2)].

Specific Populations

Sex

There is insufficient experience with the use of QUILLIVANT XR to detect gender variations in pharmacokinetics.

Race

There is insufficient experience with the use of QUILLIVANT XR to detect ethnic variations in pharmacokinetics.

Age

The pharmacokinetics of methylphenidate after QUILLIVANT XR administration were studied in pediatric patients with ADHD between 9 and 15 years of age. After a single oral dose of 60 mg QUILLIVANT XR, plasma concentrations of methylphenidate in children (9 to 12 years old; n=3) were approximately twice the concentrations observed in adults. The plasma concentrations in adolescent patients (13 to 15 years old; n=4) were similar to those in adults.

Renal Impairment

There is no experience with the use of QUILLIVANT XR in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of PPAA. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of QUILLIVANT XR.

Hepatic Impairment

There is no experience with the use of QUILLIVANT XR in patients with hepatic insufficiency.

Carcinogenesis

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 4 times the maximum recommended human dose on a mg/m2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 5 times the maximum recommended human dose on a mg/m2 basis.

Mutagenesis

Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in an in vivo mouse bone marrow micronucleus assay.

Impairment of Fertility

Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 8-fold the maximum recommended human dose on a mg/m2 basis.

The efficacy of QUILLIVANT XR was evaluated in a laboratory classroom study conducted in 45 pediatric patients (ages 6 to 12 years) with ADHD. Patients in the trial met Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV®) criteria for ADHD. The study began with an open-label dose optimization period (4 to 6 weeks) with an initial QUILLIVANT XR dose of 20 mg once daily in the morning. The dose could be titrated weekly in increments of 10 or 20 mg until a therapeutic dose or the maximum dose of 60 mg/day was reached. At the end of the dose optimization period, approximately 5% of subjects were receiving 20 mg/day; 39%, 30 mg/day; 31%, 40 mg/day; 10%, 50 mg/day; and 15%, 60 mg/day. Subjects then entered a 2-week randomized, double-blind, crossover treatment with the individually optimized dose of QUILLIVANT XR or placebo. At the end of each week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy endpoints were the SKAMP-Combined scores at 0.75, 2, 8, 10, and 12 hours post-dosing.

{ "type": "p", "children": [], "text": "The efficacy of QUILLIVANT XR was evaluated in a laboratory classroom study conducted in 45 pediatric patients (ages 6 to 12 years) with ADHD. Patients in the trial met Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV®) criteria for ADHD. The study began with an open-label dose optimization period (4 to 6 weeks) with an initial QUILLIVANT XR dose of 20 mg once daily in the morning. The dose could be titrated weekly in increments of 10 or 20 mg until a therapeutic dose or the maximum dose of 60 mg/day was reached. At the end of the dose optimization period, approximately 5% of subjects were receiving 20 mg/day; 39%, 30 mg/day; 31%, 40 mg/day; 10%, 50 mg/day; and 15%, 60 mg/day. Subjects then entered a 2-week randomized, double-blind, crossover treatment with the individually optimized dose of QUILLIVANT XR or placebo. At the end of each week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy endpoints were the SKAMP-Combined scores at 0.75, 2, 8, 10, and 12 hours post-dosing." }

Results from the first double-blind, placebo-controlled week of the study are summarized in Figure 3. SKAMP-Combined scores were statistically significantly lower (improved) at all time points (0.75, 2, 4, 8, 10, 12 hours) post-dosing with QUILLIVANT XR compared to placebo.

{ "type": "p", "children": [], "text": "Results from the first double-blind, placebo-controlled week of the study are summarized in Figure 3. SKAMP-Combined scores were statistically significantly lower (improved) at all time points (0.75, 2, 4, 8, 10, 12 hours) post-dosing with QUILLIVANT XR compared to placebo." }

Figure 3: Absolute SKAMP-Combined Score after treatment with QUILLIVANT XR or Placebo during Period 1.

{ "type": "p", "children": [], "text": "\nFigure 3: Absolute SKAMP-Combined Score after treatment with QUILLIVANT XR or Placebo during Period 1.\n" }

QUILLIVANT XR is supplied as powder that, after reconstitution with water, forms an extended-release oral suspension. The product is supplied in a carton. Each carton also contains one bottle, one oral dosing dispenser, and one bottle adapter.

The product must be reconstituted only by the pharmacist and not by the patient or caregiver. After reconstitution, the product is a light beige to tan viscous suspension containing 25 mg per 5 mL (5 mg per mL) of methylphenidate hydrochloride.

Bottles of 300 mg powder (to prepare 60 mL suspension)          NDC 24478-321-02

Bottles of 600 mg powder (to prepare 120 mL suspension)       NDC 24478-322-04

Bottles of 750 mg powder (to prepare 150 mL suspension)       NDC 24478-323-05

Bottles of 900 mg powder (to prepare 180 mL suspension)       NDC 24478-324-06

Store at 25ºC (77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]

Dispense in original container.

Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)." }

Abuse, Misuse, and Addiction

{ "type": "p", "children": [], "text": "\nAbuse, Misuse, and Addiction\n" }

Educate patients and their families about the risks of abuse, misuse, and addiction of QUILLIVANT XR, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store QUILLIVANT XR in a safe place, preferably locked, and instruct patients to not give QUILLIVANT XR to anyone else.

{ "type": "p", "children": [], "text": "Educate patients and their families about the risks of abuse, misuse, and addiction of QUILLIVANT XR, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store QUILLIVANT XR in a safe place, preferably locked, and instruct patients to not give QUILLIVANT XR to anyone else." }

Instructions for Using the Enclosed Oral Dosing Dispenser

{ "type": "p", "children": [], "text": "\nInstructions for Using the Enclosed Oral Dosing Dispenser\n" }

Provide the following instructions on administration to the patient or caregiver:

{ "type": "p", "children": [], "text": "Provide the following instructions on administration to the patient or caregiver:" }

{ "type": "ul", "children": [ "The pharmacist should provide this medicine in its original packaging (bottle within carton) with the bottle adapter fully inserted and the accompanying oral dosing dispenser. Use only with the oral dosing dispenser provided with this product.", "Check and make sure that the QUILLIVANT XR bottle contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist.", "\nVIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds before each dose, to ensure that the proper dose is administered.", "Remove the bottle cap. Confirm that the bottle adapter has been inserted into top of the bottle.", "Insert the tip of the oral dosing dispenser provided with this product into the bottle adapter.", "Turn bottle upside down and withdraw prescribed amount of QUILLIVANT XR into the oral dosing dispenser.", "Remove filled oral dosing dispenser from bottle and dispense QUILLIVANT XR directly into mouth.", "Replace bottle cap and store bottle as directed.", "Wash oral dosing dispenser after each use (components are dishwasher-safe)." ], "text": "" }

Risks to Patients with Serious Cardiac Disease

{ "type": "p", "children": [], "text": "\nRisks to Patients with Serious Cardiac Disease\n" }

Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death with QUILLIVANT XR use. Instruct patients to contact a health care provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death with QUILLIVANT XR use. Instruct patients to contact a health care provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].\n" }

Increased Blood Pressure and Heart Rate

{ "type": "p", "children": [], "text": "\nIncreased Blood Pressure and Heart Rate \n" }

Advise patients that QUILLIVANT XR can elevate blood pressure and heart rate [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Advise patients that QUILLIVANT XR can elevate blood pressure and heart rate [see Warnings and Precautions (5.3)].\n" }

Psychiatric Adverse Reactions

{ "type": "p", "children": [], "text": "\nPsychiatric Adverse Reactions\n" }

Advise patients that QUILLIVANT XR, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients that QUILLIVANT XR, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].\n" }

Priapism

{ "type": "p", "children": [], "text": "\nPriapism\n" }

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].\n" }

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud’s Phenomenon]

{ "type": "p", "children": [], "text": "\nCirculation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud’s Phenomenon]\n" }

{ "type": "ul", "children": [ "Instruct patients beginning treatment with QUILLIVANT XR about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.", "Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.", "\nInstruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking QUILLIVANT XR.\n", "Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)]." ], "text": "" }

Long-Term Suppression of Growth in Pediatric Patients

{ "type": "p", "children": [], "text": "\nLong-Term Suppression of Growth in Pediatric Patients\n" }

Advise patients, families, and caregivers that QUILLIVANT XR can cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Advise patients, families, and caregivers that QUILLIVANT XR can cause slowing of growth and weight loss [see Warnings and Precautions (5.7)].\n" }

Increased Intraocular Pressure (IOP) and Glaucoma

{ "type": "p", "children": [], "text": "\nIncreased Intraocular Pressure (IOP) and Glaucoma\n" }

Advise patients that IOP and glaucoma may occur during treatment with QUILLIVANT XR [see Warnings and Precautions (5.9)].

{ "type": "p", "children": [], "text": "Advise patients that IOP and glaucoma may occur during treatment with QUILLIVANT XR [see Warnings and Precautions (5.9)]." }

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

{ "type": "p", "children": [], "text": "\nMotor and Verbal Tics, and Worsening of Tourette’s Syndrome\n" }

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with QUILLIVANT XR. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)].

{ "type": "p", "children": [], "text": " Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with QUILLIVANT XR. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)]." }

Pregnancy Registry

{ "type": "p", "children": [], "text": "\nPregnancy Registry\n" }

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUILLIVANT XR during pregnancy [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUILLIVANT XR during pregnancy [see Use in Specific Populations (8.1)]." }

Alcohol Effect

{ "type": "p", "children": [], "text": "\nAlcohol Effect\n" }

Patients should be advised to avoid alcohol while taking QUILLIVANT XR Oral Suspension. Consumption of alcohol while taking QUILLIVANT XR may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3)].

{ "type": "p", "children": [], "text": "Patients should be advised to avoid alcohol while taking QUILLIVANT XR Oral Suspension. Consumption of alcohol while taking QUILLIVANT XR may result in a more rapid release of the dose of methylphenidate [see Clinical Pharmacology (12.3)].\n" }

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com.

{ "type": "p", "children": [], "text": "This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com." }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Manufactured by: Tris Pharma, Inc.  Monmouth Junction, NJ 08852

{ "type": "p", "children": [], "text": "Manufactured by:\nTris Pharma, Inc. \nMonmouth Junction, NJ 08852" }

LB8529 Rev. 02

{ "type": "p", "children": [], "text": "LB8529 Rev. 02 " }

Medication Guide

{ "type": "p", "children": [], "text": "\nMedication Guide\n" }

QUILLIVANT XR® (\kwil-ə-vant\) (methylphenidate hydrochloride) for extended-release oral suspension CII

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR® (\\kwil-ə-vant\\)\n(methylphenidate hydrochloride) for extended-release oral suspension CII\n" }

What is the most important information I should know about QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nWhat is the most important information I should know about QUILLIVANT XR?\n" }

QUILLIVANT XR may cause serious side effects, including:

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR may cause serious side effects, including:\n" }

{ "type": "ul", "children": [ "\nAbuse, misuse, and addiction. QUILLIVANT XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of QUILLIVANT XR, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of QUILLIVANT XR or when it is used in ways that are not approved, such as snorting or injection." ], "text": "" }

{ "type": "ul", "children": [ "Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with QUILLIVANT XR and will monitor you or your child during treatment." ], "text": "" }

{ "type": "ul", "children": [ "QUILLIVANT XR may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider." ], "text": "" }

{ "type": "ul", "children": [ "Do not give QUILLIVANT XR to anyone else. See “What is QUILLIVANT XR?” for more information." ], "text": "" }

{ "type": "ul", "children": [ "Keep QUILLIVANT XR in a safe place and properly dispose of any unused medicine. See “How should I store QUILLIVANT XR?” for more information." ], "text": "" }

{ "type": "ul", "children": [ "Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs." ], "text": "" }

{ "type": "ul", "children": [ "\nRisks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.\n \nYour healthcare provider should check you or your child carefully for heart problems before starting treatment with QUILLIVANT XR.\n\n" ], "text": "" }

Tell your health care provider if you or your child have any heart problems, heart disease, or heart defects.

{ "type": "p", "children": [], "text": "Tell your health care provider if you or your child have any heart problems, heart disease, or heart defects." }

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking QUILLIVANT XR.

{ "type": "p", "children": [], "text": "\nCall your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking QUILLIVANT XR.\n" }

{ "type": "ul", "children": [ "\nIncreased blood pressure and heart rate.\nYour health care provider should check your or your child’s blood pressure and heart rate regularly during treatment with QUILLIVANT XR.\n", "\nMental (Psychiatric) problems:\n" ], "text": "" }

{ "type": "ul", "children": [ "new or worse behavior and thought problems", "new or worse bipolar illness", "new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms" ], "text": "" }

Tell your health care provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

{ "type": "p", "children": [], "text": "Tell your health care provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression." }

Call your health care provider right away if you or your child have any new or worsening mental symptoms or problems while taking QUILLIVANT XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

{ "type": "p", "children": [], "text": "\nCall your health care provider right away if you or your child have any new or worsening mental symptoms or problems while taking QUILLIVANT XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.\n" }

What is QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nWhat is QUILLIVANT XR?\n" }

QUILLIVANT XR is a central nervous system stimulant prescription medicine. QUILLIVANT XR is a liquid medicine that you take by mouth.

{ "type": "p", "children": [], "text": "QUILLIVANT XR is a central nervous system stimulant prescription medicine. QUILLIVANT XR is a liquid medicine that you take by mouth." }

It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QUILLIVANT XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

{ "type": "p", "children": [], "text": "\nIt is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QUILLIVANT XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD." }

It is not known if QUILLIVANT XR is safe and effective in children under 6 years of age.

{ "type": "p", "children": [], "text": "It is not known if QUILLIVANT XR is safe and effective in children under 6 years of age." }

QUILLIVANT XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.Keep QUILLIVANT XR in a safe place to protect it from theft. Never give your QUILLIVANT XR to anyone else, because it may cause death or harm them. Selling or giving away QUILLIVANT XR may harm others and is against the law.

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.Keep QUILLIVANT XR in a safe place to protect it from theft. Never give your QUILLIVANT XR to anyone else, because it may cause death or harm them. Selling or giving away QUILLIVANT XR may harm others and is against the law." }

Do not take QUILLIVANT XR if you or your child:

{ "type": "p", "children": [], "text": "\nDo not take QUILLIVANT XR if you or your child:\n" }

{ "type": "ul", "children": [ "are allergic to methylphenidate hydrochloride, or any of the ingredients in QUILLIVANT XR. See the end of this Medication Guide for a complete list of ingredients in QUILLIVANT XR.", "are taking or have taken within the past 14 days a type of anti-depression medicine called a monoamine oxidase inhibitor (MAOI)." ], "text": "" }

QUILLIVANT XR may not be right for you or your child. Before starting QUILLIVANT XR tell your or your child’s health care provider about all health conditions (or a family history of) including:

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR may not be right for you or your child. Before starting QUILLIVANT XR tell your or your child’s health care provider about all health conditions (or a family history of) including:\n" }

{ "type": "ul", "children": [ "heart problems, heart disease, heart defects, or high blood pressure", "mental problems including psychosis, mania, bipolar illness, or depression", "circulation problems in fingers and toes", "have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)", "have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome", "if you are pregnant or plan to become pregnant. It is not known if QUILLIVANT XR will harm your unborn baby. Talk to your health care provider if you are pregnant or plan to become pregnant.\n \nThere is a pregnancy registry for females who are exposed to ADHD medications during pregnancy. The purpose of the registry is to collect information about the health of females exposed to QUILLIVANT XR and their baby. If you or your child becomes pregnant during treatment with QUILLIVANT XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.\n\n", "if you are breastfeeding or plan to breast feed. QUILLIVANT XR passes into your breast milk. You and your healthcare provider should decide if you will take QUILLIVANT XR or breast feed." ], "text": "" }

Tell your health care provider about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. QUILLIVANT XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking QUILLIVANT XR.

{ "type": "p", "children": [], "text": "\nTell your health care provider about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. QUILLIVANT XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking QUILLIVANT XR." }

Your health care provider will decide whether QUILLIVANT XR can be taken with other medicines.

{ "type": "p", "children": [], "text": "Your health care provider will decide whether QUILLIVANT XR can be taken with other medicines." }

Especially tell your health care provider if you or your child takes:

{ "type": "p", "children": [], "text": "\nEspecially tell your health care provider if you or your child takes:\n" }

{ "type": "ul", "children": [ "anti-depression medicines including MAOIs" ], "text": "" }

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your health care provider and pharmacist. Do not start any new medicine while taking QUILLIVANT XR without talking to your health care provider first.

{ "type": "p", "children": [], "text": " Know the medicines that you or your child takes. Keep a list of your medicines with you to show your health care provider and pharmacist. Do not start any new medicine while taking QUILLIVANT XR without talking to your health care provider first.\n" }

How should QUILLIVANT XR be taken?

{ "type": "p", "children": [], "text": "\nHow should QUILLIVANT XR be taken?\n" }

{ "type": "ul", "children": [ "\nRead the step-by-step instructions for using QUILLIVANT XR extended-release suspension at the end of this Medication Guide.\n" ], "text": "" }

{ "type": "ul", "children": [ "Take QUILLIVANT XR exactly as prescribed. Your health care provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.", "QUILLIVANT XR should be used with the oral dosing dispenser provided with the product. If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.", "Check and make sure that the QUILLIVANT XR bottle contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist.", "Check and make sure that the bottle adapter was fully inserted into the bottle by the pharmacist. If the bottle adapter is not fully inserted, insert the adapter into the bottle.", "Take QUILLIVANT XR 1 time each day in the morning. QUILLIVANT XR is an extended-release suspension. It releases medicine into your body throughout the day.", "QUILLIVANT XR can be taken with or without food. Taking QUILLIVANT XR with food may shorten the time it takes for the medicine to start working.", "Your health care provider may do regular checks of the blood, heart, and blood pressure while taking QUILLIVANT XR.", "Children should have their height and weight checked often while taking QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if a problem is found during these check-ups.", "If a dose is missed, you or your child should talk to your health care provider about dosing." ], "text": "" }

If you or your child take too much QUILLIVANT XR, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

{ "type": "p", "children": [], "text": "If you or your child take too much QUILLIVANT XR, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away." }

What should I avoid while taking QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nWhat should I avoid while taking QUILLIVANT XR?\n" }

{ "type": "ul", "children": [ "QUILLIVANT XR should not be taken with MAOI medicines. Do not start taking QUILLIVANT XR if you stopped taking an MAOI in the last 14 days.", "Do not drink alcohol while taking QUILLIVANT XR. This may cause a faster release of your methylphenidate dose." ], "text": "" }

What are the possible side effects of QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of QUILLIVANT XR?\n" }

QUILLIVANT XR may cause serious side effects, including:

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR may cause serious side effects, including:\n" }

{ "type": "ul", "children": [ "\nSee “What is the most important information I should know about QUILLIVANT XR?” for information on reported heart and mental problems." ], "text": "" }

Other serious side effects include:

{ "type": "p", "children": [], "text": "\nOther serious side effects include:\n" }

{ "type": "ul", "children": [ "\nPainful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because priapism can cause long lasting damage, it should be checked by a health care provider right away.\n", "\nCirculation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):\n\nSigns and symptoms may include:\n\n" ], "text": "" }

{ "type": "ul", "children": [ "fingers or toes may feel numb, cool, painful" ], "text": "" }

{ "type": "ul", "children": [ "fingers or toes may change color from pale, to blue, to red" ], "text": "" }

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with QUILLIVANT XR.

{ "type": "p", "children": [], "text": "Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with QUILLIVANT XR." }

{ "type": "ul", "children": [ "\nSlowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if your child is not gaining weight or height." ], "text": "" }

{ "type": "ul", "children": [ "\nEye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness." ], "text": "" }

{ "type": "ul", "children": [ "\nNew or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with QUILLIVANT XR." ], "text": "" }

The most common side effects of QUILLIVANT XR include:

{ "type": "p", "children": [], "text": "\nThe most common side effects of QUILLIVANT XR include:\n" }

{ "type": "ul", "children": [ "decreased appetite", "trouble sleeping", "nausea", "vomiting", "indigestion", "stomach pain", "weight loss", "anxiety", "dizziness", "irritability", "mood swings", "fast heart beat", "increased blood pressure" ], "text": "" }

These are not all the possible side effects of QUILLIVANT XR.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of QUILLIVANT XR." }

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "\nCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n" }

How should I store QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nHow should I store QUILLIVANT XR?\n" }

{ "type": "ul", "children": [ "Store QUILLIVANT XR at 59°F to 86°F (15°C to 30°C).", "Store QUILLIVANT XR in a safe place, like a locked cabinet.", "Dispose   of remaining, unused, or expired QUILLIVANT XR by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix QUILLIVANT XR with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away QUILLIVANT XR in the household trash. Visit http://www.fda.gov/drugdisposal for additional information on disposal of unused medicines.", "\nKeep QUILLIVANT XR and all medicines out of the reach of children.\n" ], "text": "" }

General information about the safe and effective use of QUILLIVANT XR

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of QUILLIVANT XR\n" }

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUILLIVANT XR for a condition for which it was not prescribed. Do not give QUILLIVANT XR to other people, even if they have the same condition. It may harm them.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUILLIVANT XR for a condition for which it was not prescribed. Do not give QUILLIVANT XR to other people, even if they have the same condition. It may harm them." }

You can ask your pharmacist or healthcare provider for information about QUILLIVANT XR that is written for healthcare professionals.

{ "type": "p", "children": [], "text": "You can ask your pharmacist or healthcare provider for information about QUILLIVANT XR that is written for healthcare professionals." }

What are the ingredients in QUILLIVANT XR?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in QUILLIVANT XR?\n" }

Active Ingredient: methylphenidate hydrochloride

{ "type": "p", "children": [], "text": "\nActive Ingredient: methylphenidate hydrochloride" }

Inactive Ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.

{ "type": "p", "children": [], "text": "\nInactive Ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide." }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

 Tris Pharma, Inc.

{ "type": "p", "children": [], "text": "\n Tris Pharma, Inc.\n" }

Monmouth Junction, NJ 08852

{ "type": "p", "children": [], "text": " Monmouth Junction, NJ 08852" }

For more information, go to www.quillivantxr.com or call (732)-940-0358.

{ "type": "p", "children": [], "text": "For more information, go to www.quillivantxr.com or call (732)-940-0358." }

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com

{ "type": "p", "children": [], "text": "This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com\n" }

This Medication Guide has been approved by the U.S. Food and Drug Administration.                 Revised:  10/2023

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration.                 Revised:  10/2023" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

QUILLIVANT XR® (\kwil-ə-vant\) (methylphenidate hydrochloride) for extended-release oral suspension CII

{ "type": "p", "children": [], "text": "\nQUILLIVANT XR® (\\kwil-ə-vant\\)\n\n(methylphenidate hydrochloride)\n\nfor extended-release oral suspension CII\n" }

Read this Instructions for Use before using QUILLIVANT XR and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the health care provider about your or your child’s medical condition or treatment.

{ "type": "p", "children": [], "text": "Read this Instructions for Use before using QUILLIVANT XR and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the health care provider about your or your child’s medical condition or treatment." }

<div class="scrollingtable"><table> <col/> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Step 1.</span> Remove the QUILLIVANT XR bottle and oral dosing dispenser from the box <span class="Bold">(See Figure A).</span> If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.<br/> <img alt="Figure A" src="/dailymed/image.cfm?name=quillivant-xr-6.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 2.</span> Check and make sure that the QUILLIVANT XR bottle contains liquid medicine <span class="Bold">(See Figure B).</span> If QUILLIVANT XR is still in powder form, <span class="Bold">do not use it.</span> Return it to your pharmacist.</td> </tr> <tr> <td><img alt="Figure B" src="/dailymed/image.cfm?name=quillivant-xr-7.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 3.</span><span class="Bold">Shake the bottle well</span> (up and down) for at least 10 seconds before each use <span class="Bold">(See Figure C).</span></td> </tr> <tr> <td><img alt="Figure C" src="/dailymed/image.cfm?name=quillivant-xr-8.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 4.</span> Uncap the bottle and check that the bottle adapter has been fully inserted into the bottle <span class="Bold">(See Figure D).</span> <br/> <img alt="Figure D" src="/dailymed/image.cfm?name=quillivant-xr-9.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 4 (continued).</span> If bottle adapter <span class="Bold">(See Figure E)</span> has not been inserted by the pharmacist into the bottle, insert adapter into the bottle as shown <span class="Bold">(See Figure E</span><span class="Bold"> and Figure F).</span> <br/>     <img alt="Figure E and Figure G" src="/dailymed/image.cfm?name=quillivant-xr-10.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/>     </td> </tr> <tr> <td>After the bottle adapter has been fully inserted into the bottle <span class="Bold">(See Figure G)</span>, it should not be removed. If the bottle adapter has not been inserted and is missing from the box, contact your pharmacist.<br/> The bottle adapter must be fully inserted and should be even with the mouth of the bottle and must remain in place to allow the child resistant cap to work the right way.</td> </tr> <tr> <td><img alt="Figure G" src="/dailymed/image.cfm?name=quillivant-xr-11.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 5.</span> Check the QUILLIVANT XR dose in milliliters (mL) as prescribed by your health care provider. Locate this number on the oral dosing dispenser <span class="Bold">(See Figure H).</span> <br/> <img alt="Figure H" src="/dailymed/image.cfm?name=quillivant-xr-12.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 6.</span> Insert tip of the oral dosing dispenser into the upright bottle and push the plunger all the way down <span class="Bold">(See Figure I).</span></td> </tr> <tr> <td><img alt="Figure I" src="/dailymed/image.cfm?name=quillivant-xr-13.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 7.</span> With the oral dosing dispenser in place, turn the bottle upside down. Pull the plunger to the number of mL you need (the amount of liquid medicine in <span class="Bold">Step 5 – See Figure J</span>).<br/> <img alt="Figure J" src="/dailymed/image.cfm?name=quillivant-xr-14.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 7 (continued).</span> Measure the number of mL of medicine from the white end of the plunger <span class="Bold">(See Figure K).</span> <br/> <img alt="Figure K" src="/dailymed/image.cfm?name=quillivant-xr-15.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <span class="Bold">Step 8.</span> Remove the oral dosing dispenser from the bottle adapter.<br/> <span class="Bold">Step 9.</span> Slowly squirt QUILLIVANT XR directly into your or your child’s mouth <span class="Bold">(See Figure L).</span> <br/> <img alt="Figure L" src="/dailymed/image.cfm?name=quillivant-xr-16.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/></td> </tr> <tr class="Last"> <td><span class="Bold">Step 10.</span> Cap the bottle tightly. Store the <br/> bottle upright at 59°F to 86°F (15°C to 30°C) <br/> <span class="Bold">(See Figure M).</span> <br/> Figure M<br/> <img alt="Figure M" src="/dailymed/image.cfm?name=quillivant-xr-17.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/><br/> <br/> <span class="Bold">Step 11.</span> Clean the oral dosing dispenser after <br/> each use by placing in the dishwasher, or by <br/> rinsing with tap water <span class="Bold">(See Figure N).</span> <br/> Figure N<br/> <img alt="Figure N" src="/dailymed/image.cfm?name=quillivant-xr-18.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<col/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Step 1.</span> Remove the QUILLIVANT XR bottle and oral dosing dispenser from the box <span class=\"Bold\">(See Figure A).</span> If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.<br/>\n<img alt=\"Figure A\" src=\"/dailymed/image.cfm?name=quillivant-xr-6.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 2.</span> Check and make sure that the QUILLIVANT XR bottle contains liquid medicine <span class=\"Bold\">(See Figure B).</span> If QUILLIVANT XR is still in powder form, <span class=\"Bold\">do not use it.</span> Return it to your pharmacist.</td>\n</tr>\n<tr>\n<td><img alt=\"Figure B\" src=\"/dailymed/image.cfm?name=quillivant-xr-7.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 3.</span><span class=\"Bold\">Shake the bottle well</span> (up and down) for at least 10 seconds before each use <span class=\"Bold\">(See Figure C).</span></td>\n</tr>\n<tr>\n<td><img alt=\"Figure C\" src=\"/dailymed/image.cfm?name=quillivant-xr-8.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 4.</span> Uncap the bottle and check that the bottle adapter has been fully inserted into the bottle <span class=\"Bold\">(See Figure D).</span>\n<br/>\n<img alt=\"Figure D\" src=\"/dailymed/image.cfm?name=quillivant-xr-9.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 4 (continued).</span> If bottle adapter <span class=\"Bold\">(See Figure E)</span> has not been inserted by the pharmacist into the bottle, insert adapter into the bottle as shown <span class=\"Bold\">(See Figure E</span><span class=\"Bold\"> and Figure F).</span>\n<br/>\n     <img alt=\"Figure E and Figure G\" src=\"/dailymed/image.cfm?name=quillivant-xr-10.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/>     </td>\n</tr>\n<tr>\n<td>After the bottle adapter has been fully inserted into the bottle <span class=\"Bold\">(See Figure G)</span>, it should not be removed. If the bottle adapter has not been inserted and is missing from the box, contact your pharmacist.<br/>\n The bottle adapter must be fully inserted and should be even with the mouth of the bottle and must remain in place to allow the child resistant cap to work the right way.</td>\n</tr>\n<tr>\n<td><img alt=\"Figure G\" src=\"/dailymed/image.cfm?name=quillivant-xr-11.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 5.</span> Check the QUILLIVANT XR dose in milliliters (mL) as prescribed by your health care provider. Locate this number on the oral dosing dispenser <span class=\"Bold\">(See Figure H).</span>\n<br/>\n<img alt=\"Figure H\" src=\"/dailymed/image.cfm?name=quillivant-xr-12.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 6.</span> Insert tip of the oral dosing dispenser into the upright bottle and push the plunger all the way down <span class=\"Bold\">(See Figure I).</span></td>\n</tr>\n<tr>\n<td><img alt=\"Figure I\" src=\"/dailymed/image.cfm?name=quillivant-xr-13.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 7.</span> With the oral dosing dispenser in place, turn the bottle upside down. Pull the plunger to the number of mL you need (the amount of liquid medicine in <span class=\"Bold\">Step 5 – See Figure J</span>).<br/>\n<img alt=\"Figure J\" src=\"/dailymed/image.cfm?name=quillivant-xr-14.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 7 (continued).</span> Measure the number of mL of medicine from the white end of the plunger <span class=\"Bold\">(See Figure K).</span>\n<br/>\n<img alt=\"Figure K\" src=\"/dailymed/image.cfm?name=quillivant-xr-15.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<span class=\"Bold\">Step 8.</span> Remove the oral dosing dispenser from the bottle adapter.<br/>\n<span class=\"Bold\">Step 9.</span> Slowly squirt QUILLIVANT XR directly into your or your child’s mouth <span class=\"Bold\">(See Figure L).</span>\n<br/>\n<img alt=\"Figure L\" src=\"/dailymed/image.cfm?name=quillivant-xr-16.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/></td>\n</tr>\n<tr class=\"Last\">\n<td><span class=\"Bold\">Step 10.</span> Cap the bottle tightly. Store the <br/>\n bottle upright at 59°F to 86°F (15°C to 30°C) <br/>\n<span class=\"Bold\">(See Figure M).</span>\n<br/>\n Figure M<br/>\n<img alt=\"Figure M\" src=\"/dailymed/image.cfm?name=quillivant-xr-17.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/><br/>\n<br/>\n<span class=\"Bold\">Step 11.</span> Clean the oral dosing dispenser after <br/>\n each use by placing in the dishwasher, or by <br/>\n rinsing with tap water <span class=\"Bold\">(See Figure N).</span>\n<br/>\n Figure N<br/>\n<img alt=\"Figure N\" src=\"/dailymed/image.cfm?name=quillivant-xr-18.jpg&amp;setid=c2dc2109-44a6-4797-b04e-18761dd9d45a\"/></td>\n</tr>\n</tbody>\n</table></div>" }

These Instructions for Use have been approved by the U.S. Food and Drug Administration.  Revised: 06/2021

{ "type": "p", "children": [], "text": "These Instructions for Use have been approved by the U.S. Food and Drug Administration.  Revised: 06/2021" }

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com.

{ "type": "p", "children": [], "text": "This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com." }

Distributed by:

{ "type": "p", "children": [], "text": "Distributed by:" }

Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852

{ "type": "p", "children": [], "text": "Manufactured by:\nTris Pharma, Inc.\n\nMonmouth Junction, NJ 08852" }

NDC 24478-321-02QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension300 mg/ 60 mL total volume(When reconstituted with 53 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only

{ "type": "p", "children": [], "text": "NDC 24478-321-02QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension300 mg/ 60 mL total volume(When reconstituted with 53 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only" }

NDC 24478-322-04QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension600 mg/ 120 mL total volume(When reconstituted with 105 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only

{ "type": "p", "children": [], "text": "NDC 24478-322-04QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension600 mg/ 120 mL total volume(When reconstituted with 105 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only" }

NDC 24478-323-05QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension750 mg/ 150 mL total volume(When reconstituted with 131 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only

{ "type": "p", "children": [], "text": "NDC 24478-323-05QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension750 mg/ 150 mL total volume(When reconstituted with 131 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only" }

NDC 24478-324-06QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension900 mg/ 180 mL total volume(When reconstituted with 158 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only

{ "type": "p", "children": [], "text": "NDC 24478-324-06QUILLIVANT XR® methylphenidate HCI for extended-release oral suspension900 mg/ 180 mL total volume(When reconstituted with 158 mL of water)25 mg/5 mL(5 mg/mL) When reconstitutedRx Only" }

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of:" }

{ "type": "ul", "children": [ "Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults", "Narcolepsy" ], "text": "" }

Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including Methylphenidate hydrochloride extended-release tablets, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)] .

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Methylphenidate hydrochloride extended-release tablets use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuseand Dependence (9)].

Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, Methylphenidate hydrochloride extended-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of Methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed.

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Methylphenidate hydrochloride extended-release tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

{ "type": "ul", "children": [ "10 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and “plain” on other side.", "20 mg extended-release tablets, white to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and “plain” on other side." ], "text": "" }

{ "type": "ul", "children": [ "Hypersensitivity to methylphenidate or other components of Methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate\n \n [\n \n see Adverse Reactions (6)]\n \n .\n \n ", "Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises\n \n [\n \n see Drug Interactions (7.1)]\n \n .\n \n " ], "text": "" }

CNS stimulants, including Methylphenidate hydrochloride extended-release tablets other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Methylphenidate hydrochloride extended-release tablets treatment.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Exacerbation of Preexisting Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g. comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Methylphenidate hydrochloride extended-release tablets. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

CNS stimulants, including Methylphenidate hydrochloride extended-release tablets used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants including Methylphenidate hydrochloride extended-release tablets. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The following are discussed in more detail in other sections of the labeling:

{ "type": "p", "children": [], "text": "The following are discussed in more detail in other sections of the labeling:" }

{ "type": "ul", "children": [ "Abuse and Dependence\n \n [see\n \n Boxed Warning,\n \n Warnings and Precautions (5.1),\n \n Drug Abuse and Dependence (9.2,\n \n 9.3)]\n", "Known hypersensitivity to methylphenidate or other ingredients of Methylphenidate hydrochloride extended-release tablets\n \n [\n \n see Contraindications (4)]\n \n \n", "Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors\n \n [see\n \n Contraindications (4),\n \n Drug Interactions (7.1)]\n \n \n", "Serious Cardiovascular Reactions\n \n [see\n \n Warnings and Precautions (5.2)]\n \n \n", "Blood Pressure and Heart Rate Increases\n \n [see\n \n Warnings and Precautions (5.3)]\n \n \n", "Psychiatric Adverse Reactions\n \n [see\n \n Warnings and Precautions (5.4)]\n \n \n", "Priapism\n \n [see\n \n Warnings and Precautions (5.5)]\n \n \n", "Peripheral Vasculopathy, including Raynaud’s Phenomenon\n \n [see\n \n Warnings and Precautions (5.6)]\n \n \n", "Long-term Suppression of Growth\n \n [see\n \n Warnings and Precautions (5.7)]\n \n \n" ], "text": "" }

The following adverse reactions associated with the use of all Methylphenidate hydrochloride extended-release tablets and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions associated with the use of all Methylphenidate hydrochloride extended-release tablets and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure." }

Adverse Reactions Reported with Methylphenidate hydrochloride extended-release tablets

{ "type": "p", "children": [], "text": "\nAdverse Reactions Reported with Methylphenidate hydrochloride extended-release tablets\n" }

Infections and Infestations:nasopharyngitis

{ "type": "p", "children": [], "text": "\nInfections and Infestations:nasopharyngitis\n\n " }

Blood and the Lymphatic System Disorders :leukopenia, thrombocytopenia, anemia

{ "type": "p", "children": [], "text": "\nBlood and the Lymphatic System Disorders\n \n :leukopenia, thrombocytopenia, anemia\n\n " }

Immune System Disorders:hypersensitivity reactions, including angioedema and anaphylaxis

{ "type": "p", "children": [], "text": "\nImmune System Disorders:hypersensitivity reactions, including angioedema and anaphylaxis\n\n " }

Metabolism and Nutrition Disorders:decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients

{ "type": "p", "children": [], "text": "\nMetabolism and Nutrition Disorders:decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients\n\n " }

Psychiatric Disorders:insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood

{ "type": "p", "children": [], "text": "\nPsychiatric Disorders:insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood\n\n " }

Nervous System Disorders:headache, dizziness, tremor, dyskinesia including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs

{ "type": "p", "children": [], "text": "\nNervous System Disorders:headache, dizziness, tremor, dyskinesia including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs\n\n " }

Eye Disorders:blurred vision, difficulties in visual accommodation

{ "type": "p", "children": [], "text": "\nEye Disorders:blurred vision, difficulties in visual accommodation\n\n " }

Cardiac Disorders:tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris

{ "type": "p", "children": [], "text": "\nCardiac Disorders:tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris\n\n " }

Respiratory, Thoracic and Mediastinal Disorders:cough

{ "type": "p", "children": [], "text": "\nRespiratory, Thoracic and Mediastinal Disorders:cough\n\n " }

Gastrointestinal Disorders:dry mouth, nausea, vomiting, abdominal pain, dyspepsia

{ "type": "p", "children": [], "text": "\nGastrointestinal Disorders:dry mouth, nausea, vomiting, abdominal pain, dyspepsia\n\n " }

Hepatobiliary Disorders:abnormal liver function, ranging from transaminase elevation to severe hepatic injury

{ "type": "p", "children": [], "text": "\nHepatobiliary Disorders:abnormal liver function, ranging from transaminase elevation to severe hepatic injury\n\n " }

Skin and Subcutaneous Tissue Disorders:hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura

{ "type": "p", "children": [], "text": "\nSkin and Subcutaneous Tissue Disorders:hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura\n\n " }

Musculoskeletal and Connective Tissue Disorders:arthralgia, muscle cramps, rhabdomyolysis

{ "type": "p", "children": [], "text": "\nMusculoskeletal and Connective Tissue Disorders:arthralgia, muscle cramps, rhabdomyolysis\n\n " }

Investigations:weight loss (adult ADHD patients)

{ "type": "p", "children": [], "text": "\nInvestigations:weight loss (adult ADHD patients)\n\n " }

Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products

{ "type": "p", "children": [], "text": "\nAdditional Adverse Reactions Reported with Other Methylphenidate-Containing Products\n" }

The list below shows adverse reactions not listed for Methylphenidate hydrochloride extended-release tablets that have been reported with other methylphenidate-containing products.

{ "type": "p", "children": [], "text": "The list below shows adverse reactions not listed for Methylphenidate hydrochloride extended-release tablets that have been reported with other methylphenidate-containing products." }

Blood and Lymphatic Disorders:pancytopenia

{ "type": "p", "children": [], "text": "\nBlood and Lymphatic Disorders:pancytopenia\n\n " }

Immune System Disorders:hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas

{ "type": "p", "children": [], "text": "\nImmune System Disorders:hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas\n\n " }

Psychiatric Disorders:affect lability, mania, disorientation and libido changes

{ "type": "p", "children": [], "text": "\nPsychiatric Disorders:affect lability, mania, disorientation and libido changes\n\n " }

Nervous System Disorders:migraine

{ "type": "p", "children": [], "text": "\nNervous System Disorders:migraine\n\n " }

Eye Disorders:diplopia, mydriasis

{ "type": "p", "children": [], "text": "\nEye Disorders:diplopia, mydriasis\n\n " }

Cardiac Disorders:sudden cardiac death, myocardial infarction, bradycardia, extrasystole

{ "type": "p", "children": [], "text": "\nCardiac Disorders:sudden cardiac death, myocardial infarction, bradycardia, extrasystole\n\n " }

Vascular Disorders:peripheral coldness, Raynaud's phenomenon

{ "type": "p", "children": [], "text": "\nVascular Disorders:peripheral coldness, Raynaud's phenomenon\n\n " }

Respiratory, Thoracic and Mediastinal Disorders:pharyngolaryngeal pain, dyspnea

{ "type": "p", "children": [], "text": "\nRespiratory, Thoracic and Mediastinal Disorders:pharyngolaryngeal pain, dyspnea\n\n " }

Gastrointestinal Disorders:diarrhea, constipation

{ "type": "p", "children": [], "text": "\nGastrointestinal Disorders:diarrhea, constipation\n\n " }

Skin and Subcutaneous Tissue Disorders:angioneurotic edema, erythema, fixed drug eruption

{ "type": "p", "children": [], "text": "\nSkin and Subcutaneous Tissue Disorders:angioneurotic edema, erythema, fixed drug eruption\n\n " }

Musculoskeletal, Connective Tissue and bone Disorders:myalgia, muscle twitching

{ "type": "p", "children": [], "text": "\nMusculoskeletal, Connective Tissue and bone Disorders:myalgia, muscle twitching\n\n " }

Renal and Urinary Disorders:hematuria

{ "type": "p", "children": [], "text": "\nRenal and Urinary Disorders:hematuria\n\n " }

Reproductive System and Breast Disorders:gynecomastia

{ "type": "p", "children": [], "text": "\nReproductive System and Breast Disorders:gynecomastia\n\n " }

General Disorders:fatigue, hyperpyrexia

{ "type": "p", "children": [], "text": "\nGeneral Disorders:fatigue, hyperpyrexia\n\n " }

Urogenital Disorders: priapism

{ "type": "p", "children": [], "text": "\nUrogenital Disorders: priapism\n\n " }

Table 1 presents clinically important drug interactions with Methylphenidate hydrochloride extended-release tablets

Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Tablets

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0"> <tbody class="Headless"> <tr class="First"> <td colspan="2" valign="top"> <p class="First"> <span class="Bold">Monoamine Oxidase Inhibitors (MAOI)</span> </p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Clinical Impact</span> </p> </td><td valign="top"> <p class="First">Concomitant use of MAOIs and CNS stimulants, including Methylphenidate hydrochloride extended-release tablets can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure <span class="Italics">[ <a href="#L72258ea3-7f43-4f1e-80f0-ce51257ce9f8">see</a></span><span class="Italics"><a href="#L72258ea3-7f43-4f1e-80f0-ce51257ce9f8">Contraindications (4)</a>] </span>. </p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Intervention</span> </p> </td><td valign="top"> <p class="First"> Concomitant use of Methylphenidate hydrochloride extended-release tablets with MAOIs or within 14 days after discontinuing MAOI   treatment is contraindicated..</p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Examples</span> </p> </td><td valign="top"> <p class="First">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue</p> </td> </tr> <tr> <td colspan="2" valign="top"> <p class="First"> <span class="Bold">Antihypertensive Drugs</span> </p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Clinical Impact</span> </p> </td><td valign="top"> <p class="First">Methylphenidate hydrochloride extended-release tablets may decrease the effectiveness of drugs used to treat hypertension <span class="Italics">[ <a href="#Lf5d5e1f6-a7ae-4433-8254-f48285fa2c9c">see Warnings and Precautions (5.3)</a>] </span>. </p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Intervention</span> </p> </td><td valign="top"> <p class="First">Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.</p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Examples</span> </p> </td><td valign="top"> <p class="First">Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists</p> </td> </tr> <tr> <td colspan="2" valign="top"> <p class="First"> <span class="Bold">Halogenated Anesthetics</span> </p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Clinical Impact</span> </p> </td><td valign="top"> <p class="First">Concomitant use of halogenated anesthetics and Methylphenidate hydrochloride extended-release tablets may increase the risk of sudden blood pressure and heart rate increase during surgery.</p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Intervention</span> </p> </td><td valign="top"> <p class="First">Avoid use of Methylphenidate hydrochloride extended-release tablets in patients being treated with anesthetics on the day of surgery.</p> </td> </tr> <tr> <td> <p class="First"> <span class="Italics">Examples</span> </p> </td><td valign="top"> <p class="First">halothane, isoflurane, enflurane, desflurane, sevoflurane</p> </td> </tr> <tr> <td>Risperidone</td><td valign="top"></td> </tr> <tr class="Last"> <td> <p class="First"></p> </td><td valign="top"> <p class="First">The combined use of methylphenidate with risperidone when there is a change in dose of either or both medications may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.</p> </td> </tr> </tbody> </table></div>

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/

Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy [ see Clinical Considerations].

No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

CNS stimulants, such as Methylphenidate hydrochloride extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data

Animal Data

In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents on a mg/m 2basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m 2basis).

Risk Summary

Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Methylphenidate hydrochloride extended-release tablets and any potential adverse effects on the breastfed infant from Methylphenidate hydrochloride extended-release tablets or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

The safety and effectiveness of Methylphenidate hydrochloride extended-release tablets for the treatment of ADHD have been established in pediatric patients 6 to 17 years.

The safety and effectiveness of Methylphenidate hydrochloride extended-release tablets in pediatric patients less than 6 years have not been established.

The long-term efficacy of Methylphenidate hydrochloride extended-release tablets in pediatric patients has not been established.

Long-Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including Methylphenidate hydrochloride extended-release tablets. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [ see Warnings andPrecautions (5.7)] .

Juvenile Animal Toxicity Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis.

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m 2basis) or greater times the MRHD on a mg/, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m 2basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m 2basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

Methylphenidate hydrochloride tablet has not been studied in the geriatric population.

Methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a Schedule II controlled substance.

CNS stimulants, including Methylphenidate hydrochloride extended-release tablets have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving.

Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [ see Overdosage (10)] .

To reduce the abuse of CNS stimulants including Methylphenidate hydrochloride extended-release tablets assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants [ see How Supplied/Storage and Handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for Methylphenidate hydrochloride extended-release tablets use.

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including Methylphenidate hydrochloride extended-release tablets.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Methylphenidate hydrochloride extended-release tablets. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Human Experience

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Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

{ "type": "p", "children": [], "text": "Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis." }

Overdose Management

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Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.

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Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:" }

Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol.

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol." }

Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate.

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate." }

FDA approved dissolution test differs from the USP dissolution test.

{ "type": "p", "children": [], "text": "FDA approved dissolution test differs from the USP dissolution test." }

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.

Methylphenidate is a racemic mixture comprised of the d-and l-threoenantiomers. The d-threoenantiomer is more pharmacologically active than the l-threoenantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology

A formal QT study has not been conducted in patients taking Methylphenidate hydrochloride extended-release tablets.

The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Methylphenidate hydrochloride tablets on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of dexmethylphenidate XR 40 mg (maximum recommended adult total daily dosage) in 75 healthy volunteers. Electrocardiograms (ECGs) were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval (CI) was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship.

Absorption

Methylphenidate hydrochloride in the extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the extended-release tablet compared to the Methylphenidate hydrochloride tablet measured by the urinary excretion of Methylphenidate hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49% to 168%) in children and 101% (85% to 152%) in adults. The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Methylphenidate hydrochloride tablets and 4.7 hours (1.3 to 8.2 hours) for the Methylphenidate hydrochloride extended-release tablets. An average of 67% of extended-release tablet dose was excreted in children as compared to 86% in adults.

Effect of Food

After a high-fat meal, both area under the curve (AUC) (by 25%) and C max(by 27%) are higher. Time to C max(T max) is faster after a high-fat meal (median T max: 2.5 hours) as compared to without food (median T max: 3 hours).

Distribution

Binding to plasma proteins is low (10% to 33%). The volume of distribution was 2.65 ± 1.11 L/kg for d-methylphenidate and 1.80 ± 0.91 L/kg for l-methylphenidate.

Elimination

The systemic clearance is 0.40 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate.

Metabolism

Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

Excretion

After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours. Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%). The cumulative urinary excretion of alpha-phenyl-2-piperidine acetic acid are not significantly different for Methylphenidate hydrochloride extended-release tablets.

Studies in Specific Populations

Male and Female Patients

In a clinical study involving adult subjects who received Methylphenidate hydrochloride extended-release tablets plasma concentrations of Methylphenidate hydrochloride major metabolite appeared to be greater in females than in males. No gender differences were observed for Methylphenidate hydrochloride plasma concentration in the same subjects.

Racial or Ethnic Groups

There is insufficient experience with the use of Methylphenidate hydrochloride extended-release to detect ethnic variations in pharmacokinetics.

Patients with Renal Impairment

Methylphenidate hydrochloride has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity.

Patients with Hepatic Impairment

Methylphenidate hydrochloride has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.

Carcinogenesis

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/kg/day given to children on mg/m 2basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) on a mg/m 2basis.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate.

Mutagenesis

Methylphenidate was not mutagenic in the in vitroAmes reverse mutation assay, in the in vitromouse lymphoma cell forward mutation assay, or in the in vitrochromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivoin males and females in the mouse bone marrow micronucleus assay.

Impairment of Fertility

No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2basis.

Methylphenidate hydrochloride extended-release tablets, USP are available as follows:

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10 mg: White to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and “plain” on other side.

{ "type": "p", "children": [], "text": "10 mg: White to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and “plain” on other side." }

Bottles of 100 tablets NDC 51407-527-01

{ "type": "p", "children": [], "text": "Bottles of 100 tablets NDC 51407-527-01" }

20 mg: White to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and “plain” on other side.

{ "type": "p", "children": [], "text": "20 mg: White to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and “plain” on other side." }

Bottles of 100 tablets NDC 51407-528-01

{ "type": "p", "children": [], "text": "Bottles of 100 tablets NDC 51407-528-01" }

NOTE:Methylphenidate hydrochloride extended-release tablets, USP are color-additive free.

{ "type": "p", "children": [], "text": "\nNOTE:Methylphenidate hydrochloride extended-release tablets, USP are color-additive free.\n " }

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]." }

Protect from moisture.

{ "type": "p", "children": [], "text": "Protect from moisture." }

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

{ "type": "p", "children": [], "text": "Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure." }

Disposal

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Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets, USP by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets, USP with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Methylphenidate hydrochloride extended-release tablets, USP in the household trash.

{ "type": "p", "children": [], "text": "Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets, USP by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets, USP with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Methylphenidate hydrochloride extended-release tablets, USP in the household trash." }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Controlled Substance Status/High Potential for Abuse and Dependence

{ "type": "p", "children": [], "text": "\nControlled Substance Status/High Potential for Abuse and Dependence\n" }

Advise patients that Methylphenidate hydrochloride extended-release tablets are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give Methylphenidate hydrochloride extended-release tablets to anyone else. Advise patients to store Methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1,9.2,9.3), How Supplied/Storage and Handling (16)] .

{ "type": "p", "children": [], "text": "Advise patients that Methylphenidate hydrochloride extended-release tablets are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give Methylphenidate hydrochloride extended-release tablets to anyone else. Advise patients to store Methylphenidate hydrochloride extended-release tablets in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program if available \n [see \n Boxed Warning, \n Warnings and Precautions (5.1), \n Drug Abuse and Dependence (9.1,9.2,9.3), \n How Supplied/Storage and Handling (16)] \n .\n " }

Serious Cardiovascular Risks

{ "type": "p", "children": [], "text": "\nSerious Cardiovascular Risks\n" }

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Methylphenidate hydrochloride extended-release tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [ see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Methylphenidate hydrochloride extended-release tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease \n [ \n see Warnings and Precautions (5.2)]. \n \n" }

Blood Pressure and Heart Rate Increases

{ "type": "p", "children": [], "text": "\nBlood Pressure and Heart Rate Increases\n" }

Instruct patients that Methylphenidate hydrochloride extended-release tablets can cause elevations of their blood pressure and pulse rate [ see Warnings and Precautions (5.3)] .

{ "type": "p", "children": [], "text": "Instruct patients that Methylphenidate hydrochloride extended-release tablets can cause elevations of their blood pressure and pulse rate \n [ \n see Warnings and Precautions (5.3)] \n .\n " }

Psychiatric Risks

{ "type": "p", "children": [], "text": "\nPsychiatric Risks\n" }

Advise patients that Methylphenidate hydrochloride extended-release tablets at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [ see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients that Methylphenidate hydrochloride extended-release tablets at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania \n [ \n see Warnings and Precautions (5.4)]. \n \n" }

Priapism

{ "type": "p", "children": [], "text": "\nPriapism\n" }

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism [ see Warnings and Precautions (5.5)] .

{ "type": "p", "children": [], "text": "Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism \n [ \n see Warnings and Precautions (5.5)] \n .\n " }

Circulation Problems in Fingers and Toes [Peripheral vasculopathy, including Raynaud’s Phenomenon]

{ "type": "p", "children": [], "text": "\nCirculation Problems in Fingers and Toes [Peripheral vasculopathy, including Raynaud’s Phenomenon]\n" }

Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.

{ "type": "p", "children": [], "text": "Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes." }

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate hydrochloride extended-release tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [ see Warnings and Precautions (5.6)] .

{ "type": "p", "children": [], "text": "Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate hydrochloride extended-release tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients \n [ \n see Warnings and Precautions (5.6)] \n .\n " }

Suppression of Growth

{ "type": "p", "children": [], "text": "\nSuppression of Growth\n" }

Advise patients that Methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss [ see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Advise patients that Methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss \n [ \n see Warnings and Precautions (5.7)]. \n \n" }

Pregnancy Registry

{ "type": "p", "children": [], "text": "\nPregnancy Registry\n" }

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy \n [see Use in Specific Populations (8.1)].\n " }

The Medication Guide may also be obtained by calling 877-770-3183.

{ "type": "p", "children": [], "text": "The Medication Guide may also be obtained by calling 877-770-3183." }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:\n" }

Granules Pharmaceuticals Inc.

{ "type": "p", "children": [], "text": "Granules Pharmaceuticals Inc." }

3701 Concorde Pkwy

{ "type": "p", "children": [], "text": "3701 Concorde Pkwy" }

Chantilly, VA 20151

{ "type": "p", "children": [], "text": "Chantilly, VA 20151" }

Rev. 3/2021

{ "type": "p", "children": [], "text": "\nRev. 3/2021\n" }

Marketed by:

{ "type": "p", "children": [], "text": "\nMarketed by:\n" }

GSMS, Inc.

{ "type": "p", "children": [], "text": "GSMS, Inc." }

Camarillo, CA 93012 USA

{ "type": "p", "children": [], "text": "Camarillo, CA 93012 USA" }

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="100%"> <tbody class="Headless"> <tr class="First"> <td valign="top"> <p class="First"> <span class="Bold">MEDICATION GUIDE</span> </p> <p> <span class="Bold">Methylphenidate Hydrochloride Extended-Release Tablets <img alt="CII Image" src="/dailymed/image.cfm?name=MPH-ER-cii.jpg&amp;setid=98be5c84-b348-6b8e-e053-2995a90ae4cc"/></span> </p> <p>(meth" il fen' i date hye" droe klor' ide)</p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?</span> </p> <p></p> <p> <span class="Bold">Methylphenidate hydrochloride extended-release tablets is a federal controlled substance (CII) because it can be abused or lead to dependence.</span>Keep Methylphenidate hydrochloride extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate hydrochloride extended-release tablets may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. </p> <p></p> <p> <span class="Bold">The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:</span> </p> <p></p> <p> <span class="Bold">1. <span class="Underline">Heart-related problems:</span></span> </p> <p></p> <ul> <li> <span class="Bold">sudden death in patients who have heart problems or heart defects</span> </li> </ul> <ul> <li> <span class="Bold">stroke and heart attack in adults</span> </li> </ul> <ul> <li> <span class="Bold">increased blood pressure and heart rate</span> </li> </ul> <p>Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.</p> <p>Your doctor should check you or your child carefully for heart problems before starting Methylphenidate hydrochloride extended-release tablets.</p> <p>Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate hydrochloride extended-release tablets.</p> <p></p> <p> <span class="Bold">Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets.</span> </p> <p></p> <p> <span class="Bold">2. <span class="Underline">Mental (Psychiatric) problems:</span></span> </p> <p> <span class="Bold">All Patients</span> </p> <ul> <li> <span class="Bold">new or worse behavior and thought problems</span> </li> </ul> <ul> <li> <span class="Bold">new or worse bipolar illness</span> </li> </ul> <ul> <li> <span class="Bold">new or worse aggressive behavior or hostility</span> </li> </ul> <ul> <li> <span class="Bold">new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms</span> </li> </ul> <p>Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.</p> <p> <span class="Bold">Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.</span> </p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">What is Methylphenidate hydrochloride extended-release tablets?</span> </p> <p>Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine. <span class="Bold">It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD)</span>. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. </p> <p>Methylphenidate hydrochloride extended-release tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.</p> <p>Methylphenidate hydrochloride extended-release tablets is also used in the treatment of a sleep disorder called narcolepsy.</p> <p> <span class="Bold">It is not known if</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets is safe and effective in children under 6 years of age.</span> </p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Who should not take Methylphenidate hydrochloride extended-release tablets?</span> </p> <p> <span class="Bold">Methylphenidate hydrochloride extended-release tablets should not be taken if you or your child:</span> </p> <ul> <li>are allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets.</li> </ul> <ul> <li>are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.</li> </ul> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">Methylphenidate hydrochloride extended-release tablets may not be right for you or your child. Before starting Methylphenidate hydrochloride extended-release tablets tell you or your child’s doctor about all health conditions (or a family history of) including:</span> </p> <ul> <li>heart problems, heart defects, high blood pressure</li> <li>mental problems including psychosis, mania, bipolar illness, or depression</li> <li>circulation problems in fingers or toes</li> <li>if you are pregnant or plan to become pregnant. It is not known if Methylphenidate hydrochloride extended-release tablets will harm your unborn baby. <ul> <li>There is a pregnancy registry for females who are exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with Methylphenidate hydrochloride extended-release tablets talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd­medications/.</li> <li>if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Methylphenidate hydrochloride extended-release tablets.</li> </ul> </li> </ul> <p> <span class="Bold">Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements.</span>Methylphenidate hydrochloride extended-release tablets and some medicines may interact with each other and causeserious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methylphenidate hydrochloride extended-release tablets. </p> <p>Your doctor will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines.</p> <p> <span class="Bold">Especially tell your doctor if you or your child takes:</span> </p> <ul> <li>anti-depression medicines including MAOIs</li> <li>blood pressure medicines (anti-hypertensive)</li> </ul> <p>Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.</p> <p> <span class="Bold">Do not start any new medicine while taking</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets</span><span class="Bold">without talking to your doctor first.</span> </p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">How should</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets be taken?</span> </p> <ul> <li>Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.</li> </ul> <ul> <li>Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours.</li> </ul> <ul> <li> <span class="Bold">Do not chew or crush</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets.</span>Swallow Methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Methylphenidate hydrochloride extended-release tablets whole. A different medicine may need to be prescribed. </li> </ul> <ul> <li>From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD symptoms.</li> </ul> <ul> <li>Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets.</li> </ul> <ul> <li>Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups.</li> </ul> <ul> <li> <span class="Bold">In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.</span> </li> </ul> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?</span> </p> <p> <span class="Bold">Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including:</span> </p> <p> <span class="Bold">What are possible side effects of</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?</span> </p> <ul> <li>See <span class="Bold">“What is the most important information I should know about</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?”</span>for information on reported heart and mental problems. </li> </ul> <ul> <li> <span class="Bold">painful and prolonged erections (priapism)</span>have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately. </li> </ul> <ul> <li> <span class="Bold">circulation problems in fingers and toes</span>(Peripheral vasculopathy, including Raynaud’s phenomenon): </li> <li>fingers or toes may feel numb, cool, painful</li> <li>fingers or toes may change color from pale, to blue, to red</li> </ul> <p>Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.</p> <ul> <li> <span class="Bold">Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets.</span> </li> </ul> <ul> <li> <span class="Bold">slowing of growth (height and weight) in children</span> </li> </ul> <p> <span class="Bold">Common side effects include:</span> </p> <p>• fast heart beat • abnormal heartbeat (palpitations) • headache • trouble sleeping • nervousness</p> <p>• sweating a lot • decreased appetite • dry mouth • nausea • stomach pain</p> <p> <br/> <span class="Bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span> </p> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">How should I store</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?</span> </p> <ul> <li>Store Methylphenidate hydrochloride extended-release tablets in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).</li> </ul> <ul> <li>Protect from moisture.</li> </ul> <ul> <li>Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) Methylphenidate hydrochloride extended-release tablets in the household trash.</li> </ul> <ul> <li> <span class="Bold">Keep</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children.</span> </li> </ul> </td> </tr> <tr> <td valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets.</span> </p> <p></p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about Methylphenidate hydrochloride extended-release tablets that is written for healthcare professionals. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them and it is against the law.</p> </td> </tr> <tr class="Last"> <td valign="top"> <p class="First"> <span class="Bold">What are the ingredients in</span><span class="Bold">Methylphenidate hydrochloride extended-release tablets?</span> </p> <p> <span class="Bold">Active ingredient:</span>methylphenidate hydrochloride, USP </p> <p> <span class="Bold">Inactive ingredients:</span>hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. </p> <p> <span class="Bold">Manufactured by:</span> </p> <p>Granules Pharmaceuticals Inc.</p> <p>3701 Concorde Pkwy</p> <p>Chantilly, VA 20151</p> <p></p> <p> <span class="Bold">Revised: 11/2019</span> </p> <p></p> <p> <span class="Bold">Marketed by:</span> </p> <p>GSMS, Inc.</p> <p>Camarillo, CA 93012 USA</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">MEDICATION GUIDE</span>\n</p>\n<p>\n<span class=\"Bold\">Methylphenidate Hydrochloride Extended-Release Tablets \n <img alt=\"CII Image\" src=\"/dailymed/image.cfm?name=MPH-ER-cii.jpg&amp;setid=98be5c84-b348-6b8e-e053-2995a90ae4cc\"/></span>\n</p>\n<p>(meth\" il fen' i date hye\" droe klor' ide)</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<p></p>\n<p>\n<span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets is a federal controlled substance (CII) because it can be abused or lead to dependence.</span>Keep Methylphenidate hydrochloride extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate hydrochloride extended-release tablets may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.\n </p>\n<p></p>\n<p>\n<span class=\"Bold\">The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:</span>\n</p>\n<p></p>\n<p>\n<span class=\"Bold\">1. \n <span class=\"Underline\">Heart-related problems:</span></span>\n</p>\n<p></p>\n<ul>\n<li>\n<span class=\"Bold\">sudden death in patients who have heart problems or heart defects</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">stroke and heart attack in adults</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">increased blood pressure and heart rate</span>\n</li>\n</ul>\n<p>Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.</p>\n<p>Your doctor should check you or your child carefully for heart problems before starting Methylphenidate hydrochloride extended-release tablets.</p>\n<p>Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate hydrochloride extended-release tablets.</p>\n<p></p>\n<p>\n<span class=\"Bold\">Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets.</span>\n</p>\n<p></p>\n<p>\n<span class=\"Bold\">2. \n <span class=\"Underline\">Mental (Psychiatric) problems:</span></span>\n</p>\n<p>\n<span class=\"Bold\">All Patients</span>\n</p>\n<ul>\n<li>\n<span class=\"Bold\">new or worse behavior and thought problems</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">new or worse bipolar illness</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">new or worse aggressive behavior or hostility</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms</span>\n</li>\n</ul>\n<p>Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.</p>\n<p>\n<span class=\"Bold\">Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<p>Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine. \n <span class=\"Bold\">It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD)</span>. Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.\n </p>\n<p>Methylphenidate hydrochloride extended-release tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.</p>\n<p>Methylphenidate hydrochloride extended-release tablets is also used in the treatment of a sleep disorder called narcolepsy.</p>\n<p>\n<span class=\"Bold\">It is not known if</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets is safe and effective in children under 6 years of age.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not take Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<p>\n<span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets should not be taken if you or your child:</span>\n</p>\n<ul>\n<li>are allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets.</li>\n</ul>\n<ul>\n<li>are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets may not be right for you or your child. Before starting Methylphenidate hydrochloride extended-release tablets tell you or your child’s doctor about all health conditions (or a family history of) including:</span>\n</p>\n<ul>\n<li>heart problems, heart defects, high blood pressure</li>\n<li>mental problems including psychosis, mania, bipolar illness, or depression</li>\n<li>circulation problems in fingers or toes</li>\n<li>if you are pregnant or plan to become pregnant. It is not known if Methylphenidate hydrochloride extended-release tablets will harm your unborn baby.\n\t\t\t\t\n <ul>\n<li>There is a pregnancy registry for females who are exposed to ADHD medications, including Methylphenidate hydrochloride extended-release tablets, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with Methylphenidate hydrochloride extended-release tablets talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd­medications/.</li>\n<li>if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Methylphenidate hydrochloride extended-release tablets.</li>\n</ul>\n</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements.</span>Methylphenidate hydrochloride extended-release tablets and some medicines may interact with each other and causeserious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methylphenidate hydrochloride extended-release tablets.\n </p>\n<p>Your doctor will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines.</p>\n<p>\n<span class=\"Bold\">Especially tell your doctor if you or your child takes:</span>\n</p>\n<ul>\n<li>anti-depression medicines including MAOIs</li>\n<li>blood pressure medicines (anti-hypertensive)</li>\n</ul>\n<p>Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.</p>\n<p>\n<span class=\"Bold\">Do not start any new medicine while taking</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets</span><span class=\"Bold\">without talking to your doctor first.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets be taken?</span>\n</p>\n<ul>\n<li>Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.</li>\n</ul>\n<ul>\n<li>Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours.</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">Do not chew or crush</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets.</span>Swallow Methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Methylphenidate hydrochloride extended-release tablets whole. A different medicine may need to be prescribed.\n </li>\n</ul>\n<ul>\n<li>From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD symptoms.</li>\n</ul>\n<ul>\n<li>Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets.</li>\n</ul>\n<ul>\n<li>Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups.</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<p>\n<span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including:</span>\n</p>\n<p>\n<span class=\"Bold\">What are possible side effects of</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<ul>\n<li>See \n <span class=\"Bold\">“What is the most important information I should know about</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?”</span>for information on reported heart and mental problems.\n </li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">painful and prolonged erections (priapism)</span>have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.\n </li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">circulation problems in fingers and toes</span>(Peripheral vasculopathy, including Raynaud’s phenomenon):\n </li>\n<li>fingers or toes may feel numb, cool, painful</li>\n<li>fingers or toes may change color from pale, to blue, to red</li>\n</ul>\n<p>Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.</p>\n<ul>\n<li>\n<span class=\"Bold\">Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets.</span>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">slowing of growth (height and weight) in children</span>\n</li>\n</ul>\n<p>\n<span class=\"Bold\">Common side effects include:</span>\n</p>\n<p>• fast heart beat • abnormal heartbeat (palpitations) • headache • trouble sleeping • nervousness</p>\n<p>• sweating a lot • decreased appetite • dry mouth • nausea • stomach pain</p>\n<p>\n<br/>\n<span class=\"Bold\">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<ul>\n<li>Store Methylphenidate hydrochloride extended-release tablets in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n</ul>\n<ul>\n<li>Protect from moisture.</li>\n</ul>\n<ul>\n<li>Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) Methylphenidate hydrochloride extended-release tablets in the household trash.</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">Keep</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets.</span>\n</p>\n<p></p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about Methylphenidate hydrochloride extended-release tablets that is written for healthcare professionals. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them and it is against the law.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in</span><span class=\"Bold\">Methylphenidate hydrochloride extended-release tablets?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span>methylphenidate hydrochloride, USP\n </p>\n<p>\n<span class=\"Bold\">Inactive ingredients:</span>hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate.\n </p>\n<p>\n<span class=\"Bold\">Manufactured by:</span>\n</p>\n<p>Granules Pharmaceuticals Inc.</p>\n<p>3701 Concorde Pkwy</p>\n<p>Chantilly, VA 20151</p>\n<p></p>\n<p>\n<span class=\"Bold\">Revised: 11/2019</span>\n</p>\n<p></p>\n<p>\n<span class=\"Bold\">Marketed by:</span>\n</p>\n<p>GSMS, Inc.</p>\n<p>Camarillo, CA 93012 USA</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised November 2019

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised November 2019" }

Package Label – 10 mg

{ "type": "p", "children": [], "text": "\nPackage Label – 10 mg\n" }

NDC 51407-527-01

{ "type": "p", "children": [], "text": "\nNDC 51407-527-01\n" }

Methylphenidate Hydrochloride Extended-Release Tablets, USP CII

{ "type": "p", "children": [], "text": "\nMethylphenidate Hydrochloride Extended-Release Tablets, USP CII\n" }

10 mg

{ "type": "p", "children": [], "text": "\n10 mg\n" }

PHARMACIST: Dispense the enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "\nPHARMACIST: Dispense the enclosed Medication Guide to each patient\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

100 Tablets

{ "type": "p", "children": [], "text": "\n100 Tablets\n" }

NDC 51407-528-01

{ "type": "p", "children": [], "text": "\nNDC 51407-528-01\n" }

Methylphenidate Hydrochloride Extended-Release Tablets, USP CII

{ "type": "p", "children": [], "text": "\nMethylphenidate Hydrochloride Extended-Release Tablets, USP CII\n" }

20 mg

{ "type": "p", "children": [], "text": "\n20 mg\n" }

PHARMACIST: Dispense the enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "\nPHARMACIST: Dispense the enclosed Medication Guide to each patient\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

100 Tablets

{ "type": "p", "children": [], "text": "\n100 Tablets\n" }

Methylphenidate hydrochloride oral solution is indicated for the treatment of:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride oral solution is indicated for the treatment of:" }

• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older

{ "type": "p", "children": [], "text": "• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older" }

• Narcolepsy

{ "type": "p", "children": [], "text": "• Narcolepsy" }

Prior to treating patients with methylphenidate hydrochloride oral solution, assess:

Pediatric Patients 6 years of Age and Older

The recommended starting dosage is 5 mg orally twice daily before breakfast and lunch (preferably 30 to 45 minutes before meals). Increase the dosage gradually, in increments of 5 mg to 10 mg weekly.

Daily dosage above 60 mg is not recommended.

Adults

Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. The maximum recommended daily dose is 60 mg. The average dosage is 20 to 30 mg daily. For adult patients who are unable to sleep if medication is taken late in the day, administer the last dose before 6 p.m.

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue methylphenidate hydrochloride oral solution. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue methylphenidate hydrochloride oral solution.

Methylphenidate hydrochloride oral solution is a colorless, grape flavored liquid available in a 500 mL bottle in the following strengths:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride oral solution is a colorless, grape flavored liquid available in a 500 mL bottle in the following strengths:" }

{ "type": "ul", "children": [ "5 mg per 5 mL", "10 mg per 5 mL" ], "text": "" }

Methylphenidate hydrochloride oral solution is contraindicated in patients:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride oral solution is contraindicated in patients:" }

{ "type": "ul", "children": [ "with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6)].", "receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7)]." ], "text": "" }

Methylphenidate hydrochloride oral solution has a high potential for abuse and misuse. The use of methylphenidate hydrochloride exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate hydrochloride oral solution can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing methylphenidate hydrochloride oral solution, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution to anyone else. Throughout methylphenidate hydrochloride treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Avoid methylphenidate hydrochloride use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrythmia, coronary artery disease, or other serious cardiac disease.

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases.

Monitor all methylphenidate hydrochloride-treated patients for hypertension and tachycardia.

Exacerbation of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Illness

CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating methylphenidate hydrochloride treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at the recommended dosages, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing methylphenidate hydrochloride oral solution.

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).

Methylphenidate hydrochloride-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

CNS stimulants, including methylphenidate hydrochloride oral solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.

Careful observation for digital changes is necessary during methylphenidate hydrochloride treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for methylphenidate hydrochloride-treated patients who develop signs or symptoms of peripheral vasculopathy.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.

Closely monitor growth (weight and height) in methylphenidate hydrochloride-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. The safety and effectiveness of methylphenidate hydrochloride oral solution have not been established in pediatric patient less than 6 years of age.

There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, methylphenidate hydrochloride-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)].

Prescribe methylphenidate hydrochloride oral solution to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor methylphenidate hydrochloride-treated patients with a history of abnormally increased IOP or open-angle glaucoma.

CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating methylphenidate hydrochloride oral solution, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor methylphenidate hydrochloride-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

The following adverse reactions are discussed in more detail in other sections of the labeling:

{ "type": "p", "children": [], "text": "The following adverse reactions are discussed in more detail in other sections of the labeling:" }

{ "type": "ul", "children": [ "Abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)]\n", "Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution [see Contraindications (4)]\n", "Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications (4), Drug Interactions (7)]\n", "Risks to patients with serious cardiac disease [see Warnings and Precautions (5.2)]\n", "Increased blood pressure and heart rate [see Warnings and Precautions (5.3)]\n", "Psychiatric adverse reactions [see Warnings and Precautions (5.4)]\n", "Priapism [see Warnings and Precautions (5.5)]\n", "Peripheral vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6)]\n", "Long-term suppression of growth in pediatric patients [see Warnings and Precautions (5.7)]\n", "Acute angle closure glaucoma [see Warnings and Precautions (5.8)]\n", "Increased intraocular pressure and glaucoma [see Warnings and Precautions (5.9)]\n", "Motor and verbal tics, and worsening of Tourette’s syndrome [see Warnings and Precautions (5.10)]\n" ], "text": "" }

The following adverse reactions associated with the use of methylphenidate containing products were identified in clinical studies, postmarketing reports, or literature. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions associated with the use of methylphenidate containing products were identified in clinical studies, postmarketing reports, or literature. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure." }

Infections and infestations: nasopharyngitis

{ "type": "p", "children": [], "text": "\nInfections and infestations: nasopharyngitis" }

Blood and the lymphatic system disorders: leukopenia, thrombocytopenia, anemia, pancytopenia

{ "type": "p", "children": [], "text": "\nBlood and the lymphatic system disorders: leukopenia, thrombocytopenia, anemia, pancytopenia" }

Immune system disorders: hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas

{ "type": "p", "children": [], "text": "\nImmune system disorders: hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas" }

Metabolism and nutrition disorders: decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients

{ "type": "p", "children": [], "text": "\nMetabolism and nutrition disorders: decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients" }

Psychiatric disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, affect lability, mania, disorientation, libido changes

{ "type": "p", "children": [], "text": "\nPsychiatric disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, affect lability, mania, disorientation, libido changes" }

Nervous system disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine, motor and verbal tics

{ "type": "p", "children": [], "text": "\nNervous system disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine, motor and verbal tics" }

Eye disorders: blurred vision, difficulties in visual accommodation, diplopia, mydriasis, increased intraocular pressure

{ "type": "p", "children": [], "text": "\nEye disorders: blurred vision, difficulties in visual accommodation, diplopia, mydriasis, increased intraocular pressure" }

Cardiac disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole

{ "type": "p", "children": [], "text": "\nCardiac disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole" }

Respiratory, thoracic and mediastinal disorders: cough, pharyngolaryngeal pain, dyspnea

{ "type": "p", "children": [], "text": "\nRespiratory, thoracic and mediastinal disorders: cough, pharyngolaryngeal pain, dyspnea" }

Gastrointestinal disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea

{ "type": "p", "children": [], "text": "\nGastrointestinal disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea" }

General disorders: fatigue, hyperpyrexia

{ "type": "p", "children": [], "text": "\nGeneral disorders: fatigue, hyperpyrexia" }

Hepatobiliary disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury

{ "type": "p", "children": [], "text": "\nHepatobiliary disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury" }

Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura angioneurotic edema, erythema, fixed drug eruption

{ "type": "p", "children": [], "text": "\nSkin and subcutaneous tissue disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura angioneurotic edema, erythema, fixed drug eruption" }

Musculoskeletal and connective tissue disorders: arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching

{ "type": "p", "children": [], "text": "\nMusculoskeletal and connective tissue disorders: arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching" }

Renal and urinary disorders: hematuria

{ "type": "p", "children": [], "text": "\nRenal and urinary disorders: hematuria" }

Reproductive system and breast disorders: gynecomastia

{ "type": "p", "children": [], "text": "\nReproductive system and breast disorders: gynecomastia" }

Urogenital disorders: priapism

{ "type": "p", "children": [], "text": "\nUrogenital disorders: priapism" }

Vascular disorders: peripheral coldness, Raynaud’s phenomenon

{ "type": "p", "children": [], "text": "\nVascular disorders: peripheral coldness, Raynaud’s phenomenon" }

 Investigations: weight loss

{ "type": "p", "children": [], "text": "\n Investigations: weight loss" }

Table 1 presents clinically important drug interactions with methylphenidate hydrochloride oral solution.

Table 1:          Clinically Important Drug Interactions with Methylphenidate Hydrochloride Oral Solution

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0"> <col width="1pt"/> <col/> <tbody class="Headless"> <tr class="First"> <td colspan="2"> <p class="First">Monoamine Oxidase Inhibitors (MAOI)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride oral solution, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure <span class="Italics">[see Contraindications (</span><span class="Italics"><a href="#LINK_cf0d4f74-036e-4cee-856c-f1616c7f0274">4</a></span><span class="Italics">)]</span>.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Concomitant use of methylphenidate hydrochloride oral solution with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First">Antihypertensive Drugs</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Methylphenidate hydrochloride oral solution may decrease the effectiveness of drugs used to treat hypertension <span class="Italics">[see Warnings and Precautions (</span><span class="Italics"><a href="#LINK_8ee60d7b-2bac-45d4-b0f8-6337633f9058">5.3</a></span><span class="Italics">)]</span>.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First">Halogenated Anesthetics</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Concomitant use of halogenated anesthetics and methylphenidate hydrochloride oral solution may increase the risk of sudden blood pressure and heart rate increase during surgery.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule"> <p class="First">Avoid use of methylphenidate hydrochloride oral solution in patients being treated with anesthetics on the day of surgery.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2">Risperidone</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"><span class="Italics">Clinical Impact:</span></td><td class="Botrule Lrule Rrule Toprule">Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS).</td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"><span class="Italics">Intervention:</span></td><td class="Botrule Lrule Rrule Toprule">Monitor for signs of EPS. </td> </tr> </tbody> </table></div>

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride oral solution, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations).

No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the MRHD given to adults (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Fetal/Neonatal Adverse Reactions

CNS stimulants, such as methylphenidate hydrochloride oral solution, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Animal Data

In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 65 times the MRHD of 60 mg/day given to adults on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults on a mg/m2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the MRHD of 60 mg/day given to adults on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the MRHD of 60 mg/day given to adults on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adults on a mg/m2 basis).

Risk Summary

Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

The safety and effectiveness of methylphenidate hydrochloride oral solution for the treatment of ADHD have been established in pediatric patients six years of age and older. The safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. The long-term efficacy of methylphenidate in pediatric patients has not been established.

Long-Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.6)].

Juvenile Animal Toxicity Data

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the MRHD given to children on a mg/m2 basis. The clinical significance of the long-term behavioral effects observed in rats is unknown.

Methylphenidate hydrochloride oral solution has not been studied in the geriatric population.

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a Schedule II controlled substance.

Methylphenidate hydrochloride oral solution has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)]. Methylphenidate hydrochloride oral solution can be diverted for non medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride oral solution, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection.

Physical Dependence

Methylphenidate hydrochloride oral solution may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance

Methylphenidate hydrochloride oral solution may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Clinical Effects of Overdose

{ "type": "p", "children": [], "text": "\nClinical Effects of Overdose\n" }

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

{ "type": "p", "children": [], "text": "Overdose of CNS stimulants is characterized by the following sympathomimetic effects:" }

{ "type": "ul", "children": [ "Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop." ], "text": "" }

{ "type": "ul", "children": [ "CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur." ], "text": "" }

{ "type": "ul", "children": [ "Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop." ], "text": "" }

Overdose Management

{ "type": "p", "children": [], "text": "\nOverdose Management\n" }

Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

{ "type": "p", "children": [], "text": "Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations." }

Methylphenidate hydrochloride oral solution is a CNS stimulant available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, Methylphenidate hydrochloride is (d,l racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride oral solution is a CNS stimulant available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, Methylphenidate hydrochloride is (d,l racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:" }

Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone." }

Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP.

{ "type": "p", "children": [], "text": "Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP." }

Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP.

{ "type": "p", "children": [], "text": "Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP." }

In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water.

{ "type": "p", "children": [], "text": "In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water." }

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Cardiac Electrophysiology

A formal QT study has not been conducted in subjects taking methylphenidate hydrochloride oral solution.

The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of methylphenidate hydrochloride oral solution, on the QT interval was evaluated in a double-blind, placebo- and open-label active (moxifloxacin)-controlled study following single doses of 40 mg dexmethylphenidate hydrochloride extended-release capsule in 75 healthy volunteers. Electrocardiograms were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was less than 5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time-matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident exposure response relationship.

Absorption

Following a single dose administration of 20 mg methylphenidate hydrochloride oral solution and 20 mg tablet of methylphenidate hydrochloride in healthy volunteers under fasted conditions, time to peak plasma concentration (Tmax) of methylphenidate was at 1 to 2 hours after dosing, and:

Effect of Food

Ingestion of a high-fat meal with methylphenidate hydrochloride oral solution increased methylphenidate mean Cmax and AUC by about 13% and 25%, respectively. Time to Cmax (Tmax) was delayed by approximately 1 hour.

Distribution

Plasma protein binding is 10% to 33%. The volume of distribution was 2.65 ± 1.11 L/kg for d-methylphenidate and 1.80 ± 0.91 L/kg for l-methylphenidate.

Elimination

The mean terminal half-life (t1/2) of methylphenidate was 2.7 hours following administration of 20 mg methylphenidate hydrochloride oral solution. The systemic clearance is 0.40 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate.

Metabolism

Methylphenidate is metabolized primarily by deesterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

Excretion

After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was ritalinic acid, accounting for approximately 80% of the dose.

Specific Populations

Male and Female Patients, Racial Groups, and Age

The effect of gender, race, and age on the pharmacokinetics of methylphenidate after methylphenidate hydrochloride oral solution administration have not been studied.

Patients with Renal Impairment

Methylphenidate hydrochloride oral solution has not been studied in patients with renal impairment. Since renal clearance is not an important route of methylphenidate clearance, renal impairment is expected to have little effect on the pharmacokinetics of methylphenidate hydrochloride oral solution.

Patients with Hepatic Impairment

Methylphenidate hydrochloride oral solution has not been studied in patients with hepatic impairment. Since methylphenidate is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body, hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate hydrochloride oral solution.

Carcinogenesis

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 5 times the maximum recommended human dose (MRHD) of 60 mg/kg given to adults on a mg/m2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 7 times the MRHD (adults) on a mg/m2 basis.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate.

Mutagenesis

Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay.

Impairment of Fertility

No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 13 times the maximum recommended human dose of 60 mg/day given to adults on a mg/m2 basis.

How Supplied

{ "type": "p", "children": [], "text": "\nHow Supplied\n" }

Methylphenidate hydrochloride oral solution 10 mg per 5 mL is a colorless grape flavored liquid. It is supplied in bottles of 500 mL, NDC 72162-2041-5.

{ "type": "p", "children": [], "text": "Methylphenidate hydrochloride oral solution 10 mg per 5 mL is a colorless grape flavored liquid. It is supplied in bottles of 500 mL, NDC 72162-2041-5." }

Storage and Handling

{ "type": "p", "children": [], "text": "\nStorage and Handling\n" }

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." }

Dispense in tight container with child-resistant closure.

{ "type": "p", "children": [], "text": "Dispense in tight container with child-resistant closure." }

Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504

{ "type": "p", "children": [], "text": "Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504" }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Abuse, Misuse, and Addiction

{ "type": "p", "children": [], "text": "\nAbuse, Misuse, and Addiction\n" }

Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride oral solution, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution to anyone else.

{ "type": "p", "children": [], "text": "Educate patients and their families about the risks of abuse, misuse, and addiction of methylphenidate hydrochloride oral solution, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution to anyone else." }

Risks to Patients with Serious Cardiac Disease

{ "type": "p", "children": [], "text": "\nRisks to Patients with Serious Cardiac Disease\n" }

Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride oral solution use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with methylphenidate hydrochloride oral solution use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)]." }

Increased Blood Pressure and Heart Rate

{ "type": "p", "children": [], "text": "\nIncreased Blood Pressure and Heart Rate \n" }

Instruct patients that methylphenidate hydrochloride oral solution can elevate blood pressure and heart rate [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Instruct patients that methylphenidate hydrochloride oral solution can elevate blood pressure and heart rate [see Warnings and Precautions (5.3)]." }

Psychiatric Adverse Reactions

{ "type": "p", "children": [], "text": "\nPsychiatric Adverse Reactions\n" }

Advise patients that methylphenidate hydrochloride oral solution, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients that methylphenidate hydrochloride oral solution, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)]." }

Priapism

{ "type": "p", "children": [], "text": "\nPriapism\n" }

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)]." }

Circulation Problems in Fingers and Toes (Peripheral Vasculopathy, Including Raynaud’s Phenomenon)

{ "type": "p", "children": [], "text": "\nCirculation Problems in Fingers and Toes (Peripheral Vasculopathy, Including Raynaud’s Phenomenon)\n" }

Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

{ "type": "p", "children": [], "text": "Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red." }

Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride oral solution. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride oral solution. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)]." }

Long-Term Suppression of Growth in Pediatric Patients

{ "type": "p", "children": [], "text": "\nLong-Term Suppression of Growth in Pediatric Patients\n" }

Advise patients that methylphenidate hydrochloride oral solution may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Advise patients that methylphenidate hydrochloride oral solution may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)]." }

Increased Intraocular Pressure (IOP) and Glaucoma

{ "type": "p", "children": [], "text": "\nIncreased Intraocular Pressure (IOP) and Glaucoma\n" }

Advise patients that IOP and glaucoma may occur during treatment with methylphenidate hydrochloride oral solution [see Warnings and Precautions (5.9)].

{ "type": "p", "children": [], "text": "Advise patients that IOP and glaucoma may occur during treatment with methylphenidate hydrochloride oral solution [see Warnings and Precautions (5.9)]." }

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

{ "type": "p", "children": [], "text": "\nMotor and Verbal Tics, and Worsening of Tourette’s Syndrome\n" }

Advise patients that motor and verbal tics and worsening of Tourette’s syndrome may occur during treatment with methylphenidate hydrochloride oral solution. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)].

{ "type": "p", "children": [], "text": "Advise patients that motor and verbal tics and worsening of Tourette’s syndrome may occur during treatment with methylphenidate hydrochloride oral solution. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)]." }

Pregnancy Exposure Registry

{ "type": "p", "children": [], "text": "\nPregnancy Exposure Registry\n" }

Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride oral solution during pregnancy [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride oral solution during pregnancy [see Use in Specific Populations (8.1)]." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Tris Pharma Inc.

{ "type": "p", "children": [], "text": "\nTris Pharma Inc.\n" }

Monmouth Junction, NJ 08852

{ "type": "p", "children": [], "text": "Monmouth Junction, NJ 08852" }

www.trispharma.com

{ "type": "p", "children": [], "text": "\nwww.trispharma.com\n" }

LB8477

{ "type": "p", "children": [], "text": "LB8477" }

Rev. 03

{ "type": "p", "children": [], "text": "Rev. 03" }

12/2023

{ "type": "p", "children": [], "text": "12/2023" }

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0"> <col width="1pt"/> <col/> <tbody class="Headless"> <tr class="First"> <td colspan="2"> <p class="First"> <span class="Bold">Methylphenidate Hydrochloride Oral Solution CII</span> </p> <p> <span class="Bold">(METH il FEN i date)</span> </p> <p> <span class="Bold">5 mg/5 mL and 10 mg/5 mL</span> </p> <p> <span class="Bold">Rx only</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What is the most important information I should know about Methylphenidate Hydrochloride Oral Solution?</span> </p> <p> <span class="Bold">Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including:</span> </p> <ul class="Disc"> <li> <span class="Bold">Abuse<span class="Bold">, misuse, and addiction.</span></span> Methylphenidate Hydrochloride Oral Solution has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Methylphenidate Hydrochloride Oral Solution, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Methylphenidate Hydrochloride Oral Solution or when it is used in ways that are not approved, such as snorting or injection. <ul class="Circle"> <li>Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Methylphenidate Hydrochloride Oral Solution and will monitor you or your child during treatment.</li> <li>Methylphenidate Hydrochloride Oral Solution may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.</li> <li>Do not give Methylphenidate Hydrochloride Oral Solution to anyone else. See <span class="Bold">“What is Methylphenidate Hydrochloride Oral Solution?”</span> for more information.</li> <li>Keep Methylphenidate Hydrochloride Oral Solution in a safe place and properly dispose of any unused medicine. See <span class="Bold">“How should I store Methylphenidate Hydrochloride Oral Solution?”</span> for more information.</li> <li>Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.</li> </ul> </li> <li> <span class="Bold"><span class="Bold">Risks for people with serious heart disease. </span></span>Sudden death has happened in people who have heart defects or other serious heart disease. <p class="First">Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Methylphenidate Hydrochloride Oral Solution. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.</p> <p> <span class="Bold">Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Methylphenidate Hydrochloride Oral Solution.</span> </p> </li> <li> <span class="Bold">Increased blood pressure and heart rate.</span><span class="Bold"> <br/> </span>Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Oral Solution.</li> <li> <span class="Bold">Mental (psychiatric) problems, including:</span> </li> </ul> <ul class="Circle"> <li>new or worse behavior and thought problems</li> <li>new or worse bipolar illness</li> <li>new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms</li> </ul> <p>Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.</p> <p> <span class="Bold">Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Methylphenidate Hydrochloride Oral Solution, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What is Methylphenidate Hydrochloride Oral Solution?</span> </p> <p>Methylphenidate Hydrochloride Oral Solution is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Methylphenidate Hydrochloride Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.</p> <p>It is not known if Methylphenidate Hydrochloride Oral Solution is safe and effective for use in children under 6 years of age.</p> <p> <span class="Bold">Methylphenidate Hydrochloride Oral Solution is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.</span> </p> <p>Keep Methylphenidate Hydrochloride Oral Solution in a safe place to protect it from theft. Never give your Methylphenidate Hydrochloride Oral Solution to anyone else, because it may cause death or harm them. Selling or giving away Methylphenidate Hydrochloride Oral Solution may harm others and is against the law.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Do not take Methylphenidate Hydrochloride Oral Solution if you or your child are:</span> </p> <ul class="Disc"> <li>allergic to methylphenidate hydrochloride or any of the ingredients in Methylphenidate Hydrochloride Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate Hydrochloride Oral Solution.</li> <li>taking, or have stopped taking within the past 14 days, a medicine called a monoamine oxidase inhibitor (MAOI).</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Before taking Methylphenidate Hydrochloride Oral Solution tell your healthcare provider about all your medical conditions, including if you or your child:</span> </p> <ul class="Disc"> <li>have heart problems, heart disease, heart defects, or high blood pressure</li> <li>have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression</li> </ul> <ul class="Disc"> <li>have circulation problems in fingers and toes </li> <li>have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)</li> <li>have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome</li> </ul> <ul class="Disc"> <li>are pregnant or plan to become pregnant. It is not known if Methylphenidate Hydrochloride Oral Solution will harm the unborn baby. <ul class="Circle"> <li>There is a pregnancy registry for females who are exposed to Methylphenidate Hydrochloride Oral Solution during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate Hydrochloride Oral Solution and their baby. If you or your child becomes pregnant during treatment with Methylphenidate Hydrochloride Oral Solution, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.</li> </ul> </li> </ul> <ul class="Disc"> <li>are breastfeeding or plan to breastfeed. Methylphenidate Hydrochloride Oral Solution passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Methylphenidate Hydrochloride Oral Solution.</li> </ul> <p> <span class="Bold">Tell your healthcare provider about all the medicines that you take or your child take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</p> <p>Methylphenidate Hydrochloride Oral Solution and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Methylphenidate Hydrochloride Oral Solution. Your healthcare provider will decide whether Methylphenidate Hydrochloride Oral Solution can be taken with other medicines.</p> <p> <span class="Bold">Especially tell your healthcare provider if you or your child take </span>a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).</p> <p>Know the medicines that you take or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. <span class="Bold">Do not start any new medicine during treatment with Methylphenidate Hydrochloride Oral Solution without talking to your healthcare provider first.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">How should Methylphenidate Hydrochloride Oral Solution be taken?</span> </p> <ul class="Disc"> <li>Take Methylphenidate Hydrochloride Oral Solution exactly as prescribed by your healthcare provider.</li> <li>Your healthcare provider may change the dose if needed.</li> </ul> <ul class="Disk"> <li> <span class="Bold">Children 6 years of age and older:</span> </li> </ul> <ul class="Circle"> <li>Take Methylphenidate Hydrochloride Oral Solution by mouth 2 times a day before breakfast and lunch, 30 to 45 minutes before a meal, as prescribed by your healthcare provider. </li> </ul> <ul class="Disk"> <li> <span class="Bold">Adults:</span> <ul class="Circle"> <li>Take Methylphenidate Hydrochloride Oral Solution by mouth 2 or 3 times a day, 30 to 45 minutes before a meal, as prescribed by your healthcare provider.</li> <li>For adults who have sleep problems when Methylphenidate Hydrochloride Oral Solution is taken late in the day, take your last dose of Methylphenidate Hydrochloride Oral Solution before 6 p.m.</li> </ul> </li> </ul> <ul class="Disc"> <li>If you or your child take too much Methylphenidate Hydrochloride Oral Solution, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What are the possible side effects of Methylphenidate Hydrochloride Oral Solution?</span> </p> <p> <span class="Bold">Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including:</span> </p> <ul class="Disc"> <li>See <span class="Bold">“What is the most important information I should know about Methylphenidate Hydrochloride Oral Solution?</span>”</li> <li> <span class="Bold">Painful and prolonged erections (priapism).</span> Priapism has happened in males who take products that contain methylphenidate. <span class="Bold">If you or your child develop priapism, get medical help right away.</span> </li> <li> <span class="Bold">Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).</span> Signs and symptoms may include: <ul class="Circle"> <li>fingers or toes may feel numb, cool, painful</li> <li>fingers or toes may change color from pale, to blue, to red</li> </ul> <p class="First">Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Methylphenidate Hydrochloride Oral Solution.</p> </li> <li> <span class="Bold">Slowing of growth (height and weight) in children</span>. Children should have their height and weight checked often during treatment with Methylphenidate Hydrochloride Oral Solution. Methylphenidate Hydrochloride Oral Solution treatment may be stopped if your child is not growing or gaining weight. </li> <li> <span class="Bold">Eye problems (increased pressure in the eye and glaucoma). </span>Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.</li> <li> <span class="Bold">New or worsening tics or worsening Tourette’s syndrome. </span>Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Methylphenidate Hydrochloride Oral Solution.</li> </ul> <p> <span class="Bold">The most common side effects of Methylphenidate Hydrochloride Oral Solution include:</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <ul class="Disc"> <li>increased heart rate</li> <li>headache</li> <li>anxiety</li> <li>weight loss</li> <li>dry mouth</li> <li>stomach pain</li> </ul> </td><td class="Botrule Lrule Rrule Toprule"> <ul class="Disc"> <li>irregular heart beat (palpitations)</li> <li>trouble sleeping</li> <li>sweating</li> <li>decreased appetite</li> <li>nausea</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First">These are not all the possible side effects of Methylphenidate Hydrochloride Oral Solution.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">How should I store Methylphenidate Hydrochloride Oral Solution?</span> </p> <ul class="Disc"> <li>Store Methylphenidate Hydrochloride Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C). <p class="First">Store Methylphenidate Hydrochloride Oral Solution in a safe place, like a locked cabinet.</p> </li> <li>Protect from light and moisture.</li> <li>Dispose of remaining, unused, or expired Methylphenidate Hydrochloride Oral Solution by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix Methylphenidate Hydrochloride Oral Solution with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Methylphenidate Hydrochloride Oral Solution in the household trash. Visit <a href="https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-disposal-medicines">www.fda.gov/drugdisposal</a> for additional information on disposal of unused medicines.</li> </ul> <p> <span class="Bold">Keep Methylphenidate Hydrochloride Oral Solution and all medicines out of the reach of children.</span> </p> <p> <span class="Bold">General information about the safe and effective use of Methylphenidate Hydrochloride Oral Solution.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride Oral Solution for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride Oral Solution to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Methylphenidate Hydrochloride Oral Solution that is written for healthcare professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What are the ingredients in Methylphenidate Hydrochloride Oral Solution?</span> </p> <p> <span class="Bold">Active Ingredient:</span> methylphenidate hydrochloride, USP</p> <p> <span class="Bold">Inactive Ingredients: </span>artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water.</p> <p>Manufactured by:</p> <p> <span class="Bold">Tris Pharma, Inc.</span> </p> <p>Monmouth Junction, NJ 08852</p> <p>For more information about Methylphenidate Hydrochloride Oral Solution contact Tris Pharma, Inc at 732-940-0358 or go to <a href="#www.trispharma.com">www.trispharma.com</a>.</p> <p>LB8478</p> <p>Rev. 03</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n<col width=\"1pt\"/>\n<col/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Methylphenidate Hydrochloride Oral Solution CII</span>\n</p>\n<p>\n<span class=\"Bold\">(METH il FEN i date)</span>\n</p>\n<p>\n<span class=\"Bold\">5 mg/5 mL and 10 mg/5 mL</span>\n</p>\n<p>\n<span class=\"Bold\">Rx only</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about Methylphenidate Hydrochloride Oral Solution?</span>\n</p>\n<p>\n<span class=\"Bold\">Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including:</span>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Abuse<span class=\"Bold\">, misuse, and addiction.</span></span> Methylphenidate Hydrochloride Oral Solution has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Methylphenidate Hydrochloride Oral Solution, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Methylphenidate Hydrochloride Oral Solution or when it is used in ways that are not approved, such as snorting or injection.\n <ul class=\"Circle\">\n<li>Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Methylphenidate Hydrochloride Oral Solution and will monitor you or your child during treatment.</li>\n<li>Methylphenidate Hydrochloride Oral Solution may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.</li>\n<li>Do not give Methylphenidate Hydrochloride Oral Solution to anyone else. See <span class=\"Bold\">“What is Methylphenidate Hydrochloride Oral Solution?”</span> for more information.</li>\n<li>Keep Methylphenidate Hydrochloride Oral Solution in a safe place and properly dispose of any unused medicine. See <span class=\"Bold\">“How should I store Methylphenidate Hydrochloride Oral Solution?”</span> for more information.</li>\n<li>Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\"><span class=\"Bold\">Risks for people with serious heart disease. </span></span>Sudden death has happened in people who have heart defects or other serious heart disease.\n <p class=\"First\">Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Methylphenidate Hydrochloride Oral Solution. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.</p>\n<p>\n<span class=\"Bold\">Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Methylphenidate Hydrochloride Oral Solution.</span>\n</p>\n</li>\n<li>\n<span class=\"Bold\">Increased blood pressure and heart rate.</span><span class=\"Bold\">\n<br/>\n</span>Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Oral Solution.</li>\n<li>\n<span class=\"Bold\">Mental (psychiatric) problems, including:</span>\n</li>\n</ul>\n<ul class=\"Circle\">\n<li>new or worse behavior and thought problems</li>\n<li>new or worse bipolar illness</li>\n<li>new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms</li>\n</ul>\n<p>Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.</p>\n<p>\n<span class=\"Bold\">Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Methylphenidate Hydrochloride Oral Solution, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What is Methylphenidate Hydrochloride Oral Solution?</span>\n</p>\n<p>Methylphenidate Hydrochloride Oral Solution is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Methylphenidate Hydrochloride Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.</p>\n<p>It is not known if Methylphenidate Hydrochloride Oral Solution is safe and effective for use in children under 6 years of age.</p>\n<p>\n<span class=\"Bold\">Methylphenidate Hydrochloride Oral Solution is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.</span>\n</p>\n<p>Keep Methylphenidate Hydrochloride Oral Solution in a safe place to protect it from theft. Never give your Methylphenidate Hydrochloride Oral Solution to anyone else, because it may cause death or harm them. Selling or giving away Methylphenidate Hydrochloride Oral Solution may harm others and is against the law.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Do not take Methylphenidate Hydrochloride Oral Solution if you or your child are:</span>\n</p>\n<ul class=\"Disc\">\n<li>allergic to methylphenidate hydrochloride or any of the ingredients in Methylphenidate Hydrochloride Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate Hydrochloride Oral Solution.</li>\n<li>taking, or have stopped taking within the past 14 days, a medicine called a monoamine oxidase inhibitor (MAOI).</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Before taking Methylphenidate Hydrochloride Oral Solution tell your healthcare provider about all your medical conditions, including if you or your child:</span>\n</p>\n<ul class=\"Disc\">\n<li>have heart problems, heart disease, heart defects, or high blood pressure</li>\n<li>have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression</li>\n</ul>\n<ul class=\"Disc\">\n<li>have circulation problems in fingers and toes </li>\n<li>have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)</li>\n<li>have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome</li>\n</ul>\n<ul class=\"Disc\">\n<li>are pregnant or plan to become pregnant. It is not known if Methylphenidate Hydrochloride Oral Solution will harm the unborn baby.\n <ul class=\"Circle\">\n<li>There is a pregnancy registry for females who are exposed to Methylphenidate Hydrochloride Oral Solution during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Methylphenidate Hydrochloride Oral Solution and their baby. If you or your child becomes pregnant during treatment with Methylphenidate Hydrochloride Oral Solution, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.</li>\n</ul>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>are breastfeeding or plan to breastfeed. Methylphenidate Hydrochloride Oral Solution passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Methylphenidate Hydrochloride Oral Solution.</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines that you take or your child take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</p>\n<p>Methylphenidate Hydrochloride Oral Solution and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Methylphenidate Hydrochloride Oral Solution. Your healthcare provider will decide whether Methylphenidate Hydrochloride Oral Solution can be taken with other medicines.</p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you or your child take </span>a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).</p>\n<p>Know the medicines that you take or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. <span class=\"Bold\">Do not start any new medicine during treatment with Methylphenidate Hydrochloride Oral Solution without talking to your healthcare provider first.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">How should Methylphenidate Hydrochloride Oral Solution be taken?</span>\n</p>\n<ul class=\"Disc\">\n<li>Take Methylphenidate Hydrochloride Oral Solution exactly as prescribed by your healthcare provider.</li>\n<li>Your healthcare provider may change the dose if needed.</li>\n</ul>\n<ul class=\"Disk\">\n<li>\n<span class=\"Bold\">Children 6 years of age and older:</span>\n</li>\n</ul>\n<ul class=\"Circle\">\n<li>Take Methylphenidate Hydrochloride Oral Solution by mouth 2 times a day before breakfast and lunch, 30 to 45 minutes before a meal, as prescribed by your healthcare provider.\n </li>\n</ul>\n<ul class=\"Disk\">\n<li>\n<span class=\"Bold\">Adults:</span>\n<ul class=\"Circle\">\n<li>Take Methylphenidate Hydrochloride Oral Solution by mouth 2 or 3 times a day, 30 to 45 minutes before a meal, as prescribed by your healthcare provider.</li>\n<li>For adults who have sleep problems when Methylphenidate Hydrochloride Oral Solution is taken late in the day, take your last dose of Methylphenidate Hydrochloride Oral Solution before 6 p.m.</li>\n</ul>\n</li>\n</ul>\n<ul class=\"Disc\">\n<li>If you or your child take too much Methylphenidate Hydrochloride Oral Solution, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of Methylphenidate Hydrochloride Oral Solution?</span>\n</p>\n<p>\n<span class=\"Bold\">Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including:</span>\n</p>\n<ul class=\"Disc\">\n<li>See <span class=\"Bold\">“What is the most important information I should know about Methylphenidate Hydrochloride Oral Solution?</span>”</li>\n<li>\n<span class=\"Bold\">Painful and prolonged erections (priapism).</span> Priapism has happened in males who take products that contain methylphenidate. <span class=\"Bold\">If you or your child develop priapism, get medical help right away.</span>\n</li>\n<li>\n<span class=\"Bold\">Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).</span> Signs and symptoms may include:\n <ul class=\"Circle\">\n<li>fingers or toes may feel numb, cool, painful</li>\n<li>fingers or toes may change color from pale, to blue, to red</li>\n</ul>\n<p class=\"First\">Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Methylphenidate Hydrochloride Oral Solution.</p>\n</li>\n<li>\n<span class=\"Bold\">Slowing of growth (height and weight) in children</span>. Children should have their height and weight checked often during treatment with Methylphenidate Hydrochloride Oral Solution. Methylphenidate Hydrochloride Oral Solution treatment may be stopped if your child is not growing or gaining weight. </li>\n<li>\n<span class=\"Bold\">Eye problems (increased pressure in the eye and glaucoma). </span>Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.</li>\n<li>\n<span class=\"Bold\">New or worsening tics or worsening Tourette’s syndrome. </span>Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Methylphenidate Hydrochloride Oral Solution.</li>\n</ul>\n<p>\n<span class=\"Bold\">The most common side effects of Methylphenidate Hydrochloride Oral Solution include:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<ul class=\"Disc\">\n<li>increased heart rate</li>\n<li>headache</li>\n<li>anxiety</li>\n<li>weight loss</li>\n<li>dry mouth</li>\n<li>stomach pain</li>\n</ul>\n</td><td class=\"Botrule Lrule Rrule Toprule\">\n<ul class=\"Disc\">\n<li>irregular heart beat (palpitations)</li>\n<li>trouble sleeping</li>\n<li>sweating</li>\n<li>decreased appetite</li>\n<li>nausea</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">These are not all the possible side effects of Methylphenidate Hydrochloride Oral Solution.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store Methylphenidate Hydrochloride Oral Solution?</span>\n</p>\n<ul class=\"Disc\">\n<li>Store Methylphenidate Hydrochloride Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).\n <p class=\"First\">Store Methylphenidate Hydrochloride Oral Solution in a safe place, like a locked cabinet.</p>\n</li>\n<li>Protect from light and moisture.</li>\n<li>Dispose of remaining, unused, or expired Methylphenidate Hydrochloride Oral Solution by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix Methylphenidate Hydrochloride Oral Solution with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Methylphenidate Hydrochloride Oral Solution in the household trash. Visit <a href=\"https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-disposal-medicines\">www.fda.gov/drugdisposal</a> for additional information on disposal of unused medicines.</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep Methylphenidate Hydrochloride Oral Solution and all medicines out of the reach of children.</span>\n</p>\n<p>\n<span class=\"Bold\">General information about the safe and effective use of Methylphenidate Hydrochloride Oral Solution.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride Oral Solution for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride Oral Solution to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Methylphenidate Hydrochloride Oral Solution that is written for healthcare professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in Methylphenidate Hydrochloride Oral Solution?</span>\n</p>\n<p>\n<span class=\"Bold\">Active Ingredient:</span> methylphenidate hydrochloride, USP</p>\n<p>\n<span class=\"Bold\">Inactive Ingredients: </span>artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water.</p>\n<p>Manufactured by:</p>\n<p>\n<span class=\"Bold\">Tris Pharma, Inc.</span>\n</p>\n<p>Monmouth Junction, NJ 08852</p>\n<p>For more information about Methylphenidate Hydrochloride Oral Solution contact Tris Pharma, Inc at 732-940-0358 or go to <a href=\"#www.trispharma.com\">www.trispharma.com</a>.</p>\n<p>LB8478</p>\n<p>Rev. 03</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Medication Guide has been approved by the U.S. Food and Drug Administration.      Revised: 12/2023

{ "type": "p", "children": [], "text": "This Medication Guide has been approved by the U.S. Food and Drug Administration.      Revised: 12/2023" }

Methylphenidate Hydrochloride Oral Solution (CII) 10 mg/5 mL

{ "type": "p", "children": [], "text": "\nMethylphenidate Hydrochloride Oral Solution (CII) 10 mg/5 mL\n" }

DAYTRANA (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

{ "type": "p", "children": [], "text": "\n DAYTRANA (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.\n " }

Prior to treating patients with DAYTRANA, assess:

It is recommended that DAYTRANA be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. Dosage should be titrated to effect. The recommended dose titration schedule is shown in the table below. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient.

<div class="scrollingtable"><table width="800"> <colgroup> <col align="center" width="40%"/> <col align="center" width="15%"/> <col align="center" width="15%"/> <col align="center" width="15%"/> <col align="center" width="15%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="5"> <p class="First First Footnote">*Nominal <span class="Italics">in vivo</span> delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule" colspan="5"><span class="Bold">Table 1      DAYTRANA - Recommended Titration Schedule (Patients New to Methylphenidate)</span></td> </tr> <tr> <td align="center" class="Botrule" colspan="5">Upward Titration, if Response is Not Maximized</td> </tr> <tr> <td align="center"></td><td align="center">Week 1</td><td align="center">Week 2</td><td align="center">Week 3</td><td align="center">Week 4</td> </tr> <tr> <td align="center">Transdermal System Size</td><td align="center">12.5 cm <span class="Sup">2</span></td><td align="center">18.75 cm <span class="Sup">2</span></td><td align="center">25 cm <span class="Sup">2</span></td><td align="center">37.5 cm <span class="Sup">2</span></td> </tr> <tr> <td align="center">Nominal Delivered Dose* (mg/9 hours)</td><td align="center">10 mg</td><td align="center">15 mg</td><td align="center">20 mg</td><td align="center">30 mg</td> </tr> <tr class="Last"> <td align="center" class="Botrule">Delivery Rate*</td><td align="center" class="Botrule">(1.1 mg/hr)*</td><td align="center" class="Botrule">(1.6 mg/hr)*</td><td align="center" class="Botrule">(2.2 mg/hr)*</td><td align="center" class="Botrule">(3.3 mg/hr)*</td> </tr> </tbody> </table></div>

Patients converting from another formulation of methylphenidate should follow the above titration schedule due to differences in bioavailability of DAYTRANA compared to other products.

The parent or caregiver should be encouraged to use the administration chart included with each carton of DAYTRANA to monitor application and removal time, and method of disposal. It is recommended that parents or caregivers apply and remove the transdermal system for children; responsible adolescents may apply or remove the transdermal system themselves if appropriate. If a transdermal system was removed without the parent or caregiver's knowledge, or if a transdermal system is missing from the tray, the parent or caregiver should be encouraged to ask the child when and how the transdermal system was removed. The Medication Guide includes a timetable to calculate when to remove DAYTRANA, based on the 9-hour application time.

The adhesive side of DAYTRANA should be placed on a clean, dry area of the hip. The area selected should not be oily, damaged, or irritated. Apply DAYTRANA to the hip area avoiding the waistline, since clothing may cause the transdermal system to rub off. When applying the transdermal system the next morning, place on the opposite hip at a new site if possible.

If patients or caregivers experience difficulty separating the transdermal system from the release liner or observe transfer of adhesive to the liner, tearing and/or other damage to the transdermal system during removal from the liner, the transdermal system should be discarded and a new transdermal system should be applied. Patients or caregivers should inspect the release liner to ensure that no adhesive containing medication has transferred to the liner. If adhesive transfer has occurred, the transdermal system should be discarded. Refer to the Instructions for Use for recommendations for discarding used DAYTRANA.

DAYTRANA should be applied immediately after opening the individual pouch and removing the protective liner. Do not use if the individual pouch seal is broken or if the transdermal system appears to be damaged. Do not cut transdermal systems. Only intact transdermal systems should be applied. The transdermal system should then be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure that there is good contact of the transdermal system with the skin, especially around the edges. Exposure to water during bathing, swimming, or showering can affect transdermal system adherence. DAYTRANA should not be applied or re-applied with dressings, tape, or other common adhesives. In the event that a transdermal system does not fully adhere to the skin upon application, or becomes partially or fully detached during wear time, the transdermal system should be discarded and a new transdermal system may be applied at a different site. The total recommended wear time for that day should remain 9 hours regardless of the number of transdermal systems used.

All patients should be advised to avoid exposing the DAYTRANA application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the transdermal system [see Warnings and Precautions (5.10)]. When heat is applied to DAYTRANA after transdermal system application, both the rate and the extent of absorption are significantly increased. The temperature-dependent increase in methylphenidate absorption can be greater than 2-fold [see Clinical Pharmacology (12.3)]. This increased absorption can be clinically significant and result in overdose of methylphenidate [see Overdosage (10)].

DAYTRANA should not be stored in refrigerators or freezers.

DAYTRANA should be peeled off slowly. If necessary, transdermal system removal may be facilitated by gently applying an oil-based product (i.e., petroleum jelly, olive oil, or mineral oil) to the transdermal system edges, gently working the oil underneath the transdermal system edges. If any adhesive remains on the skin following transdermal system removal, an oil-based product may be applied to transdermal system sites in an effort to gently loosen and remove any residual adhesive that remains following transdermal system removal.

In the unlikely event that a transdermal system remains tightly adhered despite these measures, the patient or caregiver should contact the physician or pharmacist. Nonmedical adhesive removers and acetone-based products (i.e., nail polish remover) should not be used to remove DAYTRANA or adhesive.

DAYTRANA may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear. Plasma concentrations of d-methylphenidate generally begin declining when the transdermal system is removed, although absorption may continue for several hours. Individualization of wear time may help manage some of the side effects caused by methylphenidate. If aggravation of symptoms or other adverse events occur, the dosage or wear time should be reduced, or, if necessary, the drug should be discontinued. Residual methylphenidate remains in used transdermal systems when worn as recommended.

Four dosage strengths are available:

{ "type": "p", "children": [], "text": "Four dosage strengths are available:" }

<div class="scrollingtable"><table width="800"> <colgroup> <col align="center" width="30%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="30%"/> </colgroup> <tfoot> <tr class="First Last"> <td align="left" colspan="4"> <p class="First First Footnote">*Nominal <span class="Italics">in vivo</span> delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule"><span class="Bold">Nominal Dose Delivered <br/>(mg) Over 9 Hours* </span></td><td align="left" class="Botrule"><span class="Bold">Dosage Rate* <br/>(mg/hr) </span></td><td align="left" class="Botrule"><span class="Bold">Transdermal System Size <br/>(cm <span class="Sup">2</span>) </span></td><td align="left" class="Botrule"><span class="Bold">Methylphenidate <br/>Content per Transdermal System (mg) </span></td> </tr> <tr> <td align="center">10</td><td align="center">1.1</td><td align="center">12.5</td><td align="center">27.5</td> </tr> <tr> <td align="center">15</td><td align="center">1.6</td><td align="center">18.75</td><td align="center">41.3</td> </tr> <tr> <td align="center">20</td><td align="center">2.2</td><td align="center">25</td><td align="center">55</td> </tr> <tr class="Last"> <td align="center" class="Botrule">30</td><td align="center" class="Botrule">3.3</td><td align="center" class="Botrule">37.5</td><td align="center" class="Botrule">82.5</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"800\">\n<colgroup>\n<col align=\"center\" width=\"30%\"/>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"30%\"/>\n</colgroup>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"4\">\n<p class=\"First First Footnote\">*Nominal <span class=\"Italics\">in vivo</span> delivery rate in children and adolescents when applied to the hip, based on a 9-hour wear period.</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule\"><span class=\"Bold\">Nominal Dose Delivered <br/>(mg) Over 9 Hours* </span></td><td align=\"left\" class=\"Botrule\"><span class=\"Bold\">Dosage Rate* <br/>(mg/hr) </span></td><td align=\"left\" class=\"Botrule\"><span class=\"Bold\">Transdermal System Size <br/>(cm <span class=\"Sup\">2</span>) </span></td><td align=\"left\" class=\"Botrule\"><span class=\"Bold\">Methylphenidate <br/>Content per Transdermal System (mg) </span></td>\n</tr>\n<tr>\n<td align=\"center\">10</td><td align=\"center\">1.1</td><td align=\"center\">12.5</td><td align=\"center\">27.5</td>\n</tr>\n<tr>\n<td align=\"center\">15</td><td align=\"center\">1.6</td><td align=\"center\">18.75</td><td align=\"center\">41.3</td>\n</tr>\n<tr>\n<td align=\"center\">20</td><td align=\"center\">2.2</td><td align=\"center\">25</td><td align=\"center\">55</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">3.3</td><td align=\"center\" class=\"Botrule\">37.5</td><td align=\"center\" class=\"Botrule\">82.5</td>\n</tr>\n</tbody>\n</table></div>" }

DAYTRANA is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product (polyester/ethylene vinyl acetate laminate film backing, acrylic adhesive, silicone adhesive, and fluoropolymer-coated polyester) [see Description (11)] .

DAYTRANA is contraindicated during treatment with monoamine oxidase inhibitors, and within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).

DAYTRANA has a high potential for abuse and misuse. The use of DAYTRANA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. DAYTRANA can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including DAYTRANA, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing DAYTRANA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their caregivers or families about these risks. Advise patients to store DAYTRANA in a safe place, preferably locked, and instruct patients to not give DAYTRANA to anyone else. Throughout DAYTRANA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

DAYTRANA has special disposal instructions. Instruct patients to find a take back location to dispose of unused or expired DAYTRANA. If a take back program is unavailable, instruct them to:

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Avoid DAYTRANA use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases.

Monitor all DAYTRANA-treated patients for hypertension and tachycardia.

Exacerbation of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disease

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating DAYTRANA treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at the recommended dosages, may cause psychotic or manic symptoms, (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing DAYTRANA.

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on the methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).

DAYTRANA-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Stimulant medications, including DAYTRANA, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.

Careful observation for digital changes is necessary during DAYTRANA treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DAYTRANA-treated patients who develop signs or symptoms of peripheral vasculopathy.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.

Closely monitor growth (weight and height) in DAYTRANA-treated pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.

DAYTRANA use may result in a persistent loss of skin pigmentation at and around the application site. Loss of pigmentation, in some cases, has been reported at other sites distant from the application site. Chemical leukoderma can mimic the appearance of vitiligo, particularly when the loss of skin pigmentation involves areas distant from the application site. Individuals with a history of vitiligo and/or a family history of vitiligo may be more at risk. Skin depigmentation may persist even after DAYTRANA use is discontinued. Monitor for signs of skin depigmentation, and advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur. Discontinue use of the DAYTRANA in patients with chemical leukoderma.

In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with DAYTRANA using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at DAYTRANA application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.

Use of DAYTRANA may lead to contact sensitization. DAYTRANA should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of DAYTRANA and is not by itself an indication of sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site. Confirmation of a diagnosis of contact sensitization (allergic contact dermatitis) may require further diagnostic testing.

Patients sensitized from use of DAYTRANA, as evidenced by development of an allergic contact dermatitis, may develop systemic sensitization or other systemic reactions if methylphenidate-containing products are taken via other routes, e.g., orally. Manifestations of systemic sensitization may include a flare-up of previous dermatitis or of prior positive patch-test sites, or generalized skin eruptions in previously unaffected skin. Other systemic reactions may include headache, fever, malaise, arthralgia, diarrhea, or vomiting. No cases of systemic sensitization have been observed in clinical trials of DAYTRANA.

Patients who develop contact sensitization to DAYTRANA and require oral treatment with methylphenidate should be initiated on oral medication under close medical supervision. It is possible that some patients sensitized to methylphenidate by exposure to DAYTRANA may not be able to take methylphenidate in any form.

Patients should be advised to avoid exposing the DAYTRANA application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the transdermal system. When heat is applied to DAYTRANA after application, both the rate and extent of absorption are significantly increased. The temperature-dependent increase in methylphenidate absorption can be greater than 2-fold [see Clinical Pharmacology (12.3)]. This increased absorption can be clinically significant and can result in overdose of methylphenidate [see Overdosage (10)].

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

There have been reports of angle closure glaucoma associated with methylphenidate treatment.

Although the mechanism is not clear, DAYTRANA-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)] .

Prescribe DAYTRANA to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor DAYTRANA-treated patients with a history of abnormally increased IOP or open angle glaucoma.

CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)] .

Before initiating DAYTRANA, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DAYTRANA-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia [see Adverse Reactions (6.1)].

The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Adverse Reactions (6.1)].

The overall DAYTRANA development program included exposure to DAYTRANA in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults. The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using DAYTRANA with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents have been exposed for ≥ 6 months. Most patients studied were exposed to DAYTRANA transdermal system sizes of 12.5 cm2, 18.75 cm2, 25 cm2 or 37.5 cm2, with a wear time of 9 hours.

In the data presented below, the adverse reactions reported during exposure were obtained primarily by general inquiry at each visit, and were recorded by the clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of events into a smaller number of standardized event categories.

Adverse Reactions in Clinical Studies with Discontinuation of Treatment

In a 7-week double-blind, parallel-group, placebo-controlled study in children with ADHD conducted in the outpatient setting, 7.1% (7/98) of patients treated with DAYTRANA discontinued due to adverse events compared with 1.2% (1/85) receiving placebo. The most commonly reported (≥ 1% and twice the rate of placebo) adverse reactions leading to discontinuation in the DAYTRANA group were application site reaction (2%), tics (1%), headache (1%), and irritability (1%).

In a 7-week double-blind, parallel-group, placebo-controlled study in adolescents with ADHD conducted in the outpatient setting, 5.5% (8/145) of patients treated with DAYTRANA discontinued due to adverse reactions compared with 2.8% (2/72) receiving placebo. The most commonly reported adverse reactions leading to discontinuation in the DAYTRANA group were application site reaction (2%) and decreased appetite/anorexia (1.4%).

Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Trials

Skin Irritation and Application Site Reactions

DAYTRANA is a dermal irritant. In addition to the most commonly reported adverse reactions presented in Table 2, the majority of subjects in those studies had minimal to definite skin erythema at the transdermal system application site. This erythema generally caused no or minimal discomfort and did not usually interfere with therapy or result in discontinuation from treatment. Erythema is not by itself a manifestation of contact sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site [see Warnings and Precautions (5.10)].

Most Commonly Reported Adverse Reactions

Table 2 lists treatment-emergent adverse reactions reported in ≥ 1% DAYTRANA-treated children or adolescents with ADHD in two 7 week double-blind, parallel-group, placebo-controlled studies conducted in the outpatient setting. Overall, in these studies, 75.5% of children and 78.6% of adolescents experienced at least 1 adverse event.

<div class="scrollingtable"><table width="800px"> <colgroup> <col align="left" width="36%"/> <col align="center" width="16%"/> <col align="center" width="16%"/> <col align="center" width="16%"/> <col align="center" width="16%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="5"> <p class="First First Footnote">* Six subjects had affect lability, all judged as mild and described as increased emotionally sensitive, emotionality, emotional instability, emotional lability, and intermittent emotional</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="5"><span class="Bold">Table 2      Number (%) of Subjects with Commonly Reported Adverse Reactions (≥ 1% in the DAYTRANA Group) in 7-Week Placebo-controlled Studies in Either Children or Adolescents - Safety Population</span></td> </tr> <tr> <td align="left" class="Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule" colspan="2">Adolescents</td><td align="center" class="Botrule Lrule Rrule" colspan="2">Children</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">System Organ Class <br/>   Preferred term</td><td align="center" class="Botrule Lrule">Placebo <br/>N = 72</td><td align="center" class="Botrule Rrule">DAYTRANA <br/>N = 145</td><td align="center" class="Botrule Lrule">Placebo <br/>N = 85</td><td align="center" class="Botrule Rrule">DAYTRANA <br/>N = 98</td> </tr> <tr> <td align="left" class="Lrule">Cardiac Disorders</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule">   Tachycardia</td><td align="center" class="Lrule">0 (0)</td><td align="center" class="Rrule">1 (0.7)</td><td align="center" class="Lrule">0 (0)</td><td align="center" class="Rrule">1 (1.0)</td> </tr> <tr> <td align="left" class="Lrule">Gastrointestinal disorders</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule">   Abdominal pain</td><td align="center" class="Lrule">0 (0)</td><td align="center" class="Rrule">7 (4.8)</td><td align="center" class="Lrule">5 (5.9)</td><td align="center" class="Rrule">7 (7.1)</td> </tr> <tr> <td align="left" class="Lrule">   Nausea</td><td align="center" class="Lrule">2 (2.8)</td><td align="center" class="Rrule">14 (9.7)</td><td align="center" class="Lrule">2 (2.4)</td><td align="center" class="Rrule">12 (12.2)</td> </tr> <tr> <td align="left" class="Botrule Lrule">   Vomiting</td><td align="center" class="Botrule Lrule">1 (1.4)</td><td align="center" class="Botrule Rrule">5 (3.4)</td><td align="center" class="Botrule Lrule">4 (4.7)</td><td align="center" class="Botrule Rrule">10 (10.2)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Investigations</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">   Weight decreased</td><td align="center" class="Botrule Lrule">1 (1.4)</td><td align="center" class="Botrule Rrule">8 (5.5)</td><td align="center" class="Botrule Lrule">0 (0)</td><td align="center" class="Botrule Rrule">9 (9.2)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Metabolism and nutrition disorders</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">   Anorexia</td><td align="center" class="Lrule">1 (1.4)</td><td align="center" class="Rrule">7 (4.8)</td><td align="center" class="Lrule">1 (1.2)</td><td align="center" class="Rrule">5 (5.1)</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">   Decreased appetite</td><td align="center" class="Botrule Lrule">1 (1.4)</td><td align="center" class="Botrule Rrule">37 (25.5)</td><td align="center" class="Botrule Lrule">4 (4.7)</td><td align="center" class="Botrule Rrule">25 (25.5)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Nervous system disorders</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">   Dizziness</td><td align="center" class="Lrule">1 (1.4)</td><td align="center" class="Rrule">8 (5.5)</td><td align="center" class="Lrule">1 (1.2)</td><td align="center" class="Rrule">0 (0)</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule">   Headache</td><td align="center" class="Botrule Lrule">9 (12.5)</td><td align="center" class="Botrule Rrule">18 (12.4)</td><td align="center" class="Botrule Lrule">10 (11.8)</td><td align="center" class="Botrule Rrule">15 (15.3)</td> </tr> <tr> <td align="left" class="Lrule Rrule">Psychiatric disorders</td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td><td align="center" class="Lrule"></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule">   Affect lability</td><td align="center" class="Lrule">1 (1.4)</td><td align="center" class="Rrule">0 (0)</td><td align="center" class="Lrule">0 (0)</td><td align="center" class="Rrule">6 (6.1)*</td> </tr> <tr> <td align="left" class="Lrule Rrule">   Insomnia</td><td align="center" class="Lrule">2 (2.8)</td><td align="center" class="Rrule">9 (6.2)</td><td align="center" class="Lrule">4 (4.7)</td><td align="center" class="Rrule">13 (13.3)</td> </tr> <tr> <td align="left" class="Lrule Rrule">   Irritability</td><td align="center" class="Lrule">5 (6.9)</td><td align="center" class="Rrule">16 (11)</td><td align="center" class="Lrule">4 (4.7)</td><td align="center" class="Rrule">7 (7.1)</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule">   Tic</td><td align="center" class="Botrule Lrule">0 (0)</td><td align="center" class="Botrule Rrule">0 (0)</td><td align="center" class="Botrule Lrule">0 (0)</td><td align="center" class="Botrule Rrule">7 (7.1)</td> </tr> </tbody> </table></div>

Adverse Reactions in Clinical Studies with the Long-Term Use of DAYTRANA

In a long-term open-label study of up to 12 months duration in 326 children wearing DAYTRANA 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite, headache, and weight decreased. A total of 30 subjects (9.2%) were withdrawn from the study due to adverse events and 22 additional subjects (6.7%) discontinued treatment as the result of an application site reaction. Other than application site reactions, affect lability (5 subjects, 1.5%) was the only additional adverse reaction leading to discontinuation reported with a frequency of greater than 1%.

In a long-term open-label study of up to 6 months duration in 162 adolescents wearing DAYTRANA 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite and headache. A total of 9 subjects (5.5%) were withdrawn from the study due to adverse events and 3 additional subjects (1.9%) discontinued treatment as the result of an application site reaction. Other adverse reactions leading to discontinuation that occurred with a frequency of greater than 1% included affect lability and irritability (2 subjects each, 1.2%).

In addition, the following adverse reactions have been identified during the post-approval use of DAYTRANA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to DAYTRANA exposure.

Cardiac Disorders: palpitations.

Eye Disorders: visual disturbances, blurred vision, increased intraocular pressure, mydriasis, and accommodation disorder.

General Disorders and Administration Site Disorders: fatigue, application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.

Immune System Disorders: hypersensitivity reactions including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis.

Investigations: blood pressure increased.

Nervous System Disorders: convulsion, dyskinesia, lethargy, somnolence, serotonin syndrome in combination with serotonergic drugs, and extrapyramidal disorder, motor, and verbal tics.

Psychiatric Disorders: depression, hallucination, nervousness, and libido changes.

Skin and Subcutaneous Tissue Disorders: alopecia.

Adverse Reactions with Oral Methylphenidate Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include:

Cardiac Disorders: angina, arrhythmia, and pulse increased or decreased.

Immune System Disorders: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura.

Metabolism and Nutrition Disorders: anorexia and weight loss during prolonged therapy.

Nervous System Disorders: drowsiness, rare reports of Tourette's syndrome and toxic psychosis.

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

Vascular Disorders: blood pressure increased or decreased and cerebral arteritis and/or occlusion.

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood and Lymphatic System Disorders: leukopenia and/or anemia.

Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury.

Psychiatric Disorders: transient depressed mood.

Skin and Subcutaneous Tissue Disorders: scalp hair loss.

Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis.

Concomitant use of MAOIs and CNS stimulants, including DAYTRANA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4.2)]. Concomitant use of DAYTRANA with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.

DAYTRANA may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see Warnings and Precautions (5.2)].

Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some tricyclic drugs (e.g., imipramine, clomipramine, desipramine) and selective serotonin reuptake inhibitors. Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

Concomitant use of halogenated anesthetics and methylphenidate may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of DAYTRANA in patients being treated with anesthetics on the day of surgery.

Combined use of methylphenidate with risperidone when there is a change in dosage, whether an increase or decrease, of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

Risk Summary

Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of CNS stimulants during pregnancy (see Clinical Considerations).

No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis. However, spina bifida was observed in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinical recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal adverse reactions

CNS stimulants, such as DAYTRANA, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

Data

Animal Data

Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally to pregnant animals during the period of organogenesis, at doses up to 100 and 200 mg/kg/day, respectively. No evidence of morphological development effects was found either of the species; however, increased incidences of fetal skeletal variations were observed in rats at 60 mg/kg or greater and an increase in fetal visceral variations was seen in rabbits at the highest dose. In a previous study, methylphenidate was shown to have malformations (increased incidence of fetal spina bifida) in rabbits when given oral doses of 200 mg/kg/day. When methylphenidate was administered orally to rats throughout pregnancy and lactation at doses of up to 60 mg/kg/day, offspring growth and survival were decreased at maternally toxic doses.

In a study in which oral methylphenidate was given to rats throughout pregnancy and lactation at doses up to 60 mg/kg/day, offspring weights and survival were decreased at 40 mg/kg/day and above; these doses caused some maternal toxicity.

Risk Summary

Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DAYTRANA and any potential adverse effects on the breastfed infant from DAYTRANA or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

The safety and effectiveness of DAYTRANA in pediatric patients less than 6 years have not been established. Long-term effects of methylphenidate in children have not been well established.

The safety and effectiveness of DAYTRANA for the treatment of ADHD have been established in pediatric patients 6 to 17 years.

Long Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including DAYTRANA. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.8)].

Juvenile Animal Toxicity Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only.

Studies with transdermal methylphenidate have not been performed in juvenile animals. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose. The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day. The clinical significance of the long-term behavioral effects observed in rats is unknown.

DAYTRANA has not been studied in patients greater than 65 years of age.

DAYTRANA contains methylphenidate, a Schedule II controlled substance.

DAYTRANA has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)]. DAYTRANA can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including DAYTRANA, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Physical Dependence

DAYTRANA may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including DAYTRANA include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance

DAYTRANA may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Clinical Effects of Overdose

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Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

{ "type": "p", "children": [], "text": "Overdose of CNS stimulants is characterized by the following sympathomimetic effects:" }

{ "type": "ul", "children": [ "Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.", "CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.", "Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop." ], "text": "" }

Overdose Management

{ "type": "p", "children": [], "text": "\nOverdose Management\n" }

Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Remove all transdermal systems immediately and cleanse the area(s) to remove any remaining adhesive. The continuing absorption of methylphenidate from the skin, even after removal of the transdermal system, should be considered when treating patients with overdose.

{ "type": "p", "children": [], "text": "Consider the possibility of multiple drug ingestion. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Remove all transdermal systems immediately and cleanse the area(s) to remove any remaining adhesive. The continuing absorption of methylphenidate from the skin, even after removal of the transdermal system, should be considered when treating patients with overdose." }

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

{ "type": "p", "children": [], "text": "Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations." }

DAYTRANA is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is:

{ "type": "p", "children": [], "text": "\nDAYTRANA is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is:\n" }

Transdermal System Components

{ "type": "p", "children": [], "text": "\nTransdermal System Components\n" }

DAYTRANA contains methylphenidate in a multipolymeric adhesive. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time.

{ "type": "p", "children": [], "text": "DAYTRANA contains methylphenidate in a multipolymeric adhesive. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the transdermal system size and wear time." }

DAYTRANA consists of three layers, as seen in the figure below (cross-section of the transdermal system).

{ "type": "p", "children": [], "text": "DAYTRANA consists of three layers, as seen in the figure below (cross-section of the transdermal system)." }

Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing, (2) a proprietary adhesive formulation incorporating Noven Pharmaceuticals, Inc.'s DOT Matrix™ transdermal technology consisting of an acrylic adhesive, a silicone adhesive, and methylphenidate, and (3) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used.

{ "type": "p", "children": [], "text": "\nProceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing, (2) a proprietary adhesive formulation incorporating Noven Pharmaceuticals, Inc.'s DOT Matrix™ transdermal technology consisting of an acrylic adhesive, a silicone adhesive, and methylphenidate, and (3) a fluoropolymer-coated polyester protective liner, which is attached to the adhesive surface and must be removed before the transdermal system can be used.\n" }

The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive.

{ "type": "p", "children": [], "text": "The active component of the transdermal system is methylphenidate. The remaining components are pharmacologically inactive." }

Methylphenidate is a CNS stimulant. Its mode of therapeutic action in ADHD is not known.

Methylphenidate is a racemic mixture comprised of the d-and l-enantiomers. The d-enantiomer is more pharmacologically active than the l-enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

The pharmacokinetics of DAYTRANA when applied to the hip for 9 hours have been studied in ADHD patients 6 to 17 years old.

Absorption

The amount of methylphenidate absorbed systemically is a function of both wear time and transdermal system size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat transdermal system applications (12.5cm2 to 37.5cm2) when worn up to 9 hours.

On single dosing of children or adolescents with DAYTRANA, there was a delay of, on average, 2 hours before d-methylphenidate was detectable in the circulation. On repeat dosing, low concentrations (1.2-3.0 ng/mL in children and 0.5-1.7ng/mL in adolescents, on average across the dose range) were observed earlier in the profile, due to carry-over effect. Following the application of DAYTRANA once daily with a 9-hour wear time, the mean pharmacokinetic parameters of d-methylphenidate in children and adolescents with ADHD after 4 weeks of therapy are summarized in Table 3.

<div class="scrollingtable"><table width="800"> <colgroup> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="5"> <p class="First First Footnote"> <span class="Sup">1</span> Dose maintained fixed for 28 days;</p> <p class="Footnote"> <span class="Sup">2</span> Dose escalated at 7 day intervals from 12.5 cm<span class="Sup">2</span> through 18.75 cm<span class="Sup">2</span> and 25 cm<span class="Sup">2</span> to 37.5 cm<span class="Sup">2</span>;</p> <p class="Footnote"> <span class="Sup">3</span> Dose escalated at 7 day intervals from 18 mg through 27 mg and 36 mg to 54 mg;</p> <p class="Footnote"> <span class="Sup">4</span> Median (minimum - maximum); t <span class="Sub">lag</span> = Last Sampling Time Prior to Time of First Quantifiable Plasma Concentration</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule" colspan="5"><span class="Bold">Table 3 <br/>Mean Plasma d-Methylphenidate Pharmacokinetic Parameters After Repeated 9-Hour Applications of DAYTRANA or Oral ER-MPH for up to 28 days to Pediatric ADHD Patients (Aged 6 - 17 years) </span></td> </tr> <tr> <td align="left" class="Botrule" colspan="5"><span class="Italics">Children</span></td> </tr> <tr valign="top"> <td align="center" class="Botrule">Parameter</td><td align="center" class="Botrule">DAYTRANA <span class="Sup">1</span> <br/>12.5cm <span class="Sup">2</span> <br/>(N=12)</td><td align="center" class="Botrule">DAYTRANA <span class="Sup">2</span> <br/>37.5cm <span class="Sup">2</span> <br/>(N=10)</td><td align="center" class="Botrule">Oral ER-MPH <span class="Sup">3</span> <br/>18mg</td><td align="center" class="Botrule">Oral ER-MPH <span class="Sup">3</span> <br/>54mg</td> </tr> <tr> <td align="center" class="Botrul">C <span class="Sub">ssmax</span> <br/>(ng/mL)</td><td align="center">15.7 ± 9.39</td><td align="center">42.9 ± 22.4</td><td align="center">8.37 ± 4.14</td><td align="center">26.1 ± 11.2</td> </tr> <tr> <td align="center">C <span class="Sub">ssmin</span> <br/>(ng/mL)</td><td align="center">1.04 ± 1.17</td><td align="center">1.96 ± 1.73</td><td align="center">0.708 ± 1.08</td><td align="center">1.19 ± 1.54</td> </tr> <tr> <td align="center">AUC <span class="Sub">ss </span> <br/>(ng·hr/mL)</td><td align="center">163 ± 101</td><td align="center">447 ± 230</td><td align="center">97.7 ± 67.0</td><td align="center">317 ± 160</td> </tr> <tr> <td align="center" class="Botrule">t <span class="Sub">lag</span> <br/>(h) <span class="Sup">4</span></td><td align="center" class="Botrule">0 (0 - 2.0)</td><td align="center" class="Botrule">0 (0 - 1.0)</td><td align="center" class="Botrule">0</td><td align="center" class="Botrule">0</td> </tr> <tr> <td align="left" class="Botrule" colspan="5"><span class="Italics">Adolescents</span></td> </tr> <tr> <td align="center">C <span class="Sub">ssmax </span> <br/>(ng/mL)</td><td align="center">8.32 ± 4.60</td><td align="center">16.5 ± 6.94</td><td align="center">5.23 ± 1.72</td><td align="center">18.0 ± 6.97</td> </tr> <tr> <td align="center">C <span class="Sub">ssmin</span> <br/>(ng/mL)</td><td align="center">0.544 ± 0.383</td><td align="center">1.02 ± 0.629</td><td align="center">0.360 ± 0.478</td><td align="center">1.50 ± 0.937</td> </tr> <tr> <td align="center">AUC <span class="Sub">ss </span> <br/>(ng·hr/mL)</td><td align="center">85.7 ± 50.0</td><td align="center">167 ± 66.0</td><td align="center">59.7 ± 19.1</td><td align="center">216 ± 80.8</td> </tr> <tr class="Last"> <td align="center">t <span class="Sub">lag</span> <br/>(h) <span class="Sup">4</span></td><td align="center">0 (0 - 2.0)</td><td align="center">0 (0 - 2.0)</td><td align="center">0</td><td align="center">0</td> </tr> </tbody> </table></div>

Following administration of DAYTRANA 12.5cm2 to pediatric and adolescent ADHD patients daily for 7 days, there were 13% and 14% increases, respectively, in steady state area under the plasma concentration-time curve (AUC ss) relative to that anticipated on the basis of single dose pharmacokinetics (AUC0 -∞); after 28 days administration, these increments increased to 64% and 76%, respectively. C max increased by nearly 69% and 100% within 4 weeks of daily administration of the starting dose in children and adolescents, respectively.

The observed exposures with DAYTRANA could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender. This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with DAYTRANA; on average, steady-state is likely to have been achieved by approximately 14 days of dosing.

In the single- and multiple dose study described above, exposure to l-methylphenidate was 46% of the exposure to d-methylphenidate in children and 40% in adolescents. l-methylphenidate is less pharmacologically active than d-methylphenidate [see Pharmacodynamics (12.2)] .

In a phase 2 PK/PD study in children aged 6-12 years, 2/3 of patients had 2-hour d-MPH concentrations < 5 ng/mL on chronic dosing, and at 3 hours 40% of patients had d-MPH concentrations < 5 ng/mL [see Clinical Studies (14)] .

When DAYTRANA is applied to inflamed skin both the rate and extent of absorption are increased as compared with intact skin. When applied to inflamed skin, lag time is no greater than 1 hour, T max is 4 hours, and both C max and AUC are approximately 3-fold higher.

When heat is applied to DAYTRANA after application, both the rate and the extent of absorption are significantly increased. Median T lag occurs 1 hour earlier, T max occurs 0.5 hours earlier, and median C max and AUC are 2-fold and 2.5-fold higher, respectively.

Application sites other than the hip can have different absorption characteristics and have not been adequately studied in safety or efficacy studies.

Dose Proportionality

Following a single 9-hour application of DAYTRANA doses of 10 mg / 9 hours to 30 mg / 9 hours transdermal systems to 34 children with ADHD, C max and AUC 0-t of d-methylphenidate were proportional to the transdermal system dose. Mean plasma concentration-time plots are shown in Figure 1. C max of l-methylphenidate was also proportional to the transdermal system dose. AUC 0-t of l-methylphenidate was only slightly greater than proportional to transdermal system dose.

Distribution

Upon removal of DAYTRANA, methylphenidate plasma concentrations in children with ADHD decline in a biexponential manner. This may be due to continued distribution of MPH from the skin after transdermal system removal.

Metabolism and Excretion

Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

Transdermal administration of methylphenidate exhibits much less first pass effect than oral administration. Consequently, a much lower dose of DAYTRANA on a mg/kg basis compared to oral dosages may still produce higher exposures of d-MPH with transdermal administration compared to oral administration. In addition, very little, if any, l-methylphenidate is systemically available after oral administration due to first pass metabolism, whereas after transdermal administration of racemic methylphenidate exposure to l-methylphenidate is nearly as high as to d-methylphenidate.

The mean elimination t 1/2 from plasma of d-methylphenidate after removal of DAYTRANA in children aged 6 to 12 years and adolescents aged 13-17 years was approximately 4 to 5 hours. The t 1/2 of l-methylphenidate was shorter than for d-methylphenidate and ranged from 1.4 to 2.9 hours, on average.

The C max and AUC of d-methylphenidate were approximately 50% lower in adolescents, compared to children, following either a 1-day or 7-day administration of DAYTRANA (10mg/9hr). Multiple-dose administration of DAYTRANA did not result in significant accumulation of methylphenidate; following 7 days of DAYTRANA administration (10mg/9hr) in children and adolescents, the accumulation index of methylphenidate was 1.1, based on the mean steady state area under the plasma concentration-time curve (AUC ss) relative to that anticipated on the basis of single dose pharmacokinetics (AUC 0-∞).

Food Effects

The pharmacokinetics or the pharmacodynamic food effect performance after application of DAYTRANA has not been studied, but because of the transdermal route of administration, no food effect is expected.

Special Populations

Gender

The pharmacokinetics of methylphenidate after single and repeated doses of DAYTRANA were similar between boys and girls with ADHD, after allowance for differences in body weight.

Race

The influence of race on the pharmacokinetics of methylphenidate after administration of DAYTRANA has not been defined.

Age

The pharmacokinetics of methylphenidate after administration of DAYTRANA have not been studied in children less than 6 years of age.

Renal Impairment

There is no experience with the use of DAYTRANA in patients with renal insufficiency.

Hepatic Impairment

There is no experience with the use of DAYTRANA in patients with hepatic insufficiency.

Carcinogenesis

Carcinogenicity studies of transdermal methylphenidate have not been performed. In a lifetime carcinogenicity study of oral methylphenidate carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown.

Orally administered methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.

In a 24-week oral carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. In this study, male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate.

Mutagenesis

Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay.

Impairment of Fertility

Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day.

DAYTRANA was demonstrated to be effective in the treatment of ADHD in two (2) randomized double-blind, placebo-controlled studies in children aged 6 to 12 years and one (1) randomized, double-blind, placebo-controlled study in adolescents aged 13 to 17 years who met Diagnostic and Statistical Manual (DSM-IV-TR®) criteria for ADHD. DAYTRANA wear time was 9 hours in all three (3) studies.

{ "type": "p", "children": [], "text": "DAYTRANA was demonstrated to be effective in the treatment of ADHD in two (2) randomized double-blind, placebo-controlled studies in children aged 6 to 12 years and one (1) randomized, double-blind, placebo-controlled study in adolescents aged 13 to 17 years who met Diagnostic and Statistical Manual (DSM-IV-TR®) criteria for ADHD. DAYTRANA wear time was 9 hours in all three (3) studies." }

In Study 1, conducted in a classroom setting, symptoms of ADHD were evaluated by school teachers and observers using the Deportment Subscale from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale which assesses behavior symptoms in the classroom setting. DAYTRANA was applied for 9 hours before removal. There was a 5-week open-label DAYTRANA dose optimization phase using dosages of 10, 15, 20, and 30 mg / 9 hours, followed by a 2-week randomized, double-blind, placebo-controlled crossover treatment phase using the optimal transdermal system dose for each patient or placebo. The mean differences between DAYTRANA and placebo in change from baseline in SKAMP Deportment Scores were statistically significant in favor of DAYTRANA beginning at 2 hours and remained statistically significant at all subsequent measured time points through 12 hours after application of DAYTRANA.

{ "type": "p", "children": [], "text": "In Study 1, conducted in a classroom setting, symptoms of ADHD were evaluated by school teachers and observers using the Deportment Subscale from the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale which assesses behavior symptoms in the classroom setting. DAYTRANA was applied for 9 hours before removal. There was a 5-week open-label DAYTRANA dose optimization phase using dosages of 10, 15, 20, and 30 mg / 9 hours, followed by a 2-week randomized, double-blind, placebo-controlled crossover treatment phase using the optimal transdermal system dose for each patient or placebo. The mean differences between DAYTRANA and placebo in change from baseline in SKAMP Deportment Scores were statistically significant in favor of DAYTRANA beginning at 2 hours and remained statistically significant at all subsequent measured time points through 12 hours after application of DAYTRANA." }

In Study 2, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours to achieve an optimal regimen over 5 weeks, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated by the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline for the ADHD-RS-IV total score. Although this study was not designed specifically to evaluate dose response, in general there did not appear to be any additional effectiveness accomplished by increasing the transdermal system dose from 20 mg / 9 hours to 30 mg / 9 hours.

{ "type": "p", "children": [], "text": "In Study 2, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours to achieve an optimal regimen over 5 weeks, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated by the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline for the ADHD-RS-IV total score. Although this study was not designed specifically to evaluate dose response, in general there did not appear to be any additional effectiveness accomplished by increasing the transdermal system dose from 20 mg / 9 hours to 30 mg / 9 hours." }

In Study 3, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours during a 5-week dose-optimization phase, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated using the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline in the ADHD-RS-IV total score.

{ "type": "p", "children": [], "text": "In Study 3, conducted in the outpatient setting, DAYTRANA or placebo was blindly administered in a flexible-dose design using doses of 10, 15, 20, and 30 mg / 9 hours during a 5-week dose-optimization phase, followed by a 2-week maintenance period using the optimal transdermal system dose for each patient. Symptoms of ADHD were evaluated using the ADHD-Rating Scale (RS)-IV. DAYTRANA was statistically significantly superior to placebo as measured by the mean change from baseline in the ADHD-RS-IV total score." }

DAYTRANA is supplied in a sealed tray containing 30 individually pouched transdermal systems. See the chart below for information regarding available strengths.

{ "type": "p", "children": [], "text": "\n DAYTRANA is supplied in a sealed tray containing 30 individually pouched transdermal systems. See the chart below for information regarding available strengths.\n " }

<div class="scrollingtable"><table width="800px"> <colgroup> <col align="center" width="20%"/> <col align="center" width="14%"/> <col align="center" width="14%"/> <col align="center" width="22%"/> <col align="center" width="12%"/> <col align="center" width="18%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="6"> <p class="First First Footnote">*Nominal <span class="Italics">in vivo</span> delivery rate per hour in children and adolescents when applied to the hip, based on a 9-hour wear period.</p> <p class="Footnote">**Methylphenidate content in each transdermal system.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First" valign="top"> <td align="center" class="Botrule"><span class="Bold">Nominal Dose <br/>Delivered (mg) <br/>Over 9 Hours </span></td><td align="center" class="Botrule"><span class="Bold">Dosage <br/>Rate* <br/>(mg/hr) </span></td><td align="center" class="Botrule"><span class="Bold">Transdermal System<br/>Size (cm <span class="Sup">2</span>) </span></td><td align="center" class="Botrule"><span class="Bold">Methylphenidate <br/>Content per <br/>Transdermal System** (mg) </span></td><td align="center" class="Botrule"><span class="Bold">Transdermal Systems<br/>Per <br/>Carton </span></td><td align="center" class="Botrule"><span class="Bold">NDC Number</span></td> </tr> <tr> <td align="center" class="Botrule">10</td><td align="center" class="Botrule">1.1</td><td align="center" class="Botrule">12.5</td><td align="center" class="Botrule">27.5</td><td align="center" class="Botrule">30</td><td align="center" class="Botrule">68968-5552-3</td> </tr> <tr> <td align="center" class="Botrule">15</td><td align="center" class="Botrule">1.6</td><td align="center" class="Botrule">18.75</td><td align="center" class="Botrule">41.3</td><td align="center" class="Botrule">30</td><td align="center" class="Botrule">68968-5553-3</td> </tr> <tr> <td align="center" class="Botrule">20</td><td align="center" class="Botrule">2.2</td><td align="center" class="Botrule">25</td><td align="center" class="Botrule">55</td><td align="center" class="Botrule">30</td><td align="center" class="Botrule">68968-5554-3</td> </tr> <tr class="Last"> <td align="center" class="Botrule">30</td><td align="center" class="Botrule">3.3</td><td align="center" class="Botrule">37.5</td><td align="center" class="Botrule">82.5</td><td align="center" class="Botrule">30</td><td align="center" class="Botrule">68968-5555-3</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"800px\">\n<colgroup>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"14%\"/>\n<col align=\"center\" width=\"14%\"/>\n<col align=\"center\" width=\"22%\"/>\n<col align=\"center\" width=\"12%\"/>\n<col align=\"center\" width=\"18%\"/>\n</colgroup>\n<tfoot>\n<tr class=\"First First Last Last\">\n<td align=\"left\" colspan=\"6\">\n<p class=\"First First Footnote\">*Nominal <span class=\"Italics\">in vivo</span> delivery rate per hour in children and adolescents when applied to the hip, based on a 9-hour wear period.</p>\n<p class=\"Footnote\">**Methylphenidate content in each transdermal system.</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\" valign=\"top\">\n<td align=\"center\" class=\"Botrule\"><span class=\"Bold\">Nominal Dose <br/>Delivered (mg) <br/>Over 9 Hours </span></td><td align=\"center\" class=\"Botrule\"><span class=\"Bold\">Dosage <br/>Rate* <br/>(mg/hr) </span></td><td align=\"center\" class=\"Botrule\"><span class=\"Bold\">Transdermal System<br/>Size (cm <span class=\"Sup\">2</span>) </span></td><td align=\"center\" class=\"Botrule\"><span class=\"Bold\">Methylphenidate <br/>Content per <br/>Transdermal System** (mg) </span></td><td align=\"center\" class=\"Botrule\"><span class=\"Bold\">Transdermal Systems<br/>Per <br/>Carton </span></td><td align=\"center\" class=\"Botrule\"><span class=\"Bold\">NDC Number</span></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule\">10</td><td align=\"center\" class=\"Botrule\">1.1</td><td align=\"center\" class=\"Botrule\">12.5</td><td align=\"center\" class=\"Botrule\">27.5</td><td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">68968-5552-3</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule\">15</td><td align=\"center\" class=\"Botrule\">1.6</td><td align=\"center\" class=\"Botrule\">18.75</td><td align=\"center\" class=\"Botrule\">41.3</td><td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">68968-5553-3</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule\">20</td><td align=\"center\" class=\"Botrule\">2.2</td><td align=\"center\" class=\"Botrule\">25</td><td align=\"center\" class=\"Botrule\">55</td><td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">68968-5554-3</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">3.3</td><td align=\"center\" class=\"Botrule\">37.5</td><td align=\"center\" class=\"Botrule\">82.5</td><td align=\"center\" class=\"Botrule\">30</td><td align=\"center\" class=\"Botrule\">68968-5555-3</td>\n</tr>\n</tbody>\n</table></div>" }

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Do not store transdermal systems unpouched. Do not store transdermal systems in refrigerators or freezers.

{ "type": "p", "children": [], "text": "Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Do not store transdermal systems unpouched. Do not store transdermal systems in refrigerators or freezers." }

Once the sealed tray is opened, use contents within 2 months. Apply the transdermal system immediately upon removal from the individual protective pouch. For transdermal use only.

{ "type": "p", "children": [], "text": "\n Once the sealed tray is opened, use contents within 2 months. Apply the transdermal system immediately upon removal from the individual protective pouch. For transdermal use only.\n " }

See the Patient Counseling Information (17) for specific disposal instructions for unused or expired DAYTRANA.

{ "type": "p", "children": [], "text": "See the Patient Counseling Information (17) for specific disposal instructions for unused or expired DAYTRANA." }

Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)." }

Abuse, Misuse, and Addiction

{ "type": "p", "children": [], "text": "\nAbuse, Misuse, and Addiction\n" }

Educate patients and their families about the risks of abuse, misuse, and addiction of DAYTRANA, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store DAYTRANA in a safe place, preferably locked, and instruct patients to not give DAYTRANA to anyone else.

{ "type": "p", "children": [], "text": "Educate patients and their families about the risks of abuse, misuse, and addiction of DAYTRANA, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store DAYTRANA in a safe place, preferably locked, and instruct patients to not give DAYTRANA to anyone else." }

Special Disposal Instructions

{ "type": "p", "children": [], "text": "\nSpecial Disposal Instructions\n" }

Advise patients that there are special disposal instructions for unused or expired DAYTRANA [see Warnings and Precautions (5.1)]. Instruct patients to find a take back location to dispose of unused or expired DAYTRANA. If a take back program is unavailable, instruct them to:

{ "type": "p", "children": [], "text": "Advise patients that there are special disposal instructions for unused or expired DAYTRANA [see Warnings and Precautions (5.1)]. Instruct patients to find a take back location to dispose of unused or expired DAYTRANA. If a take back program is unavailable, instruct them to:" }

{ "type": "", "children": [], "text": "" }

Risks to Patients with Serious Cardiac Disease

{ "type": "p", "children": [], "text": "\nRisks to Patients with Serious Cardiac Disease\n" }

Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with DAYTRANA use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with DAYTRANA use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)]." }

Priapism

{ "type": "p", "children": [], "text": "\nPriapism\n" }

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.6)].\n" }

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] [see Warnings and Precautions (5.7)]

{ "type": "p", "children": [], "text": "\nCirculation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] [see Warnings and Precautions (5.7)]\n" }

{ "type": "ul", "children": [ "Instruct patients beginning treatment with DAYTRANA about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.", "Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.", "Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while using DAYTRANA.", "Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients." ], "text": "" }

Long-Term Suppression of Growth in Pediatric Patients

{ "type": "p", "children": [], "text": "\nLong-Term Suppression of Growth in Pediatric Patients\n" }

Advise patients that DAYTRANA may cause slowing of growth including weight loss [see Warnings and (5.8)].

{ "type": "p", "children": [], "text": "Advise patients that DAYTRANA may cause slowing of growth including weight loss [see Warnings and (5.8)]." }

Chemical Leukoderma

{ "type": "p", "children": [], "text": "\nChemical Leukoderma\n" }

Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [see Warnings and Precautions (5.9)].

{ "type": "p", "children": [], "text": "Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [see Warnings and Precautions (5.9)]." }

Increased Intraocular Pressure (IOP) and Glaucoma

{ "type": "p", "children": [], "text": "\nIncreased Intraocular Pressure (IOP) and Glaucoma\n" }

Advise patients that IOP and glaucoma may occur during treatment with DAYTRANA [see Warnings and Precautions (5.14)].

{ "type": "p", "children": [], "text": "Advise patients that IOP and glaucoma may occur during treatment with DAYTRANA [see Warnings and Precautions (5.14)]." }

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

{ "type": "p", "children": [], "text": "\nMotor and Verbal Tics, and Worsening of Tourette’s Syndrome\n" }

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with DAYTRANA. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.15)].

{ "type": "p", "children": [], "text": "Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with DAYTRANA. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.15)]." }

Important Preparation and Administration Instructions [see Dosage and Administration (2.3)]

{ "type": "p", "children": [], "text": "\nImportant Preparation and Administration Instructions [see Dosage and Administration (2.3)]\n" }

{ "type": "ul", "children": [ "Parents and patients should be informed to apply DAYTRANA to a clean, dry site on the hip, which is not oily, damaged, or irritated. The site of application must be alternated daily. DAYTRANA should not be applied to the waistline, or where tight clothing may rub it.", "If patients or caregivers experience difficulty separating the transdermal system from the release liner or observe tearing and/or other damage to the transdermal system during removal from the liner, the transdermal system should be discarded according to the directions provided in this label, and a new transdermal system should be applied [see Dosage and Administration (2.3)]. Patients or caregivers should inspect the release liner to ensure that no adhesive containing medication has transferred to the liner. If adhesive transfer has occurred, the transdermal system should be discarded.", "DAYTRANA should be applied 2 hours before the desired effect. DAYTRANA should be removed approximately 9 hours after it is applied, although the effects from the transdermal system will last for several more hours. DAYTRANA may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.", "The parent or caregiver should be encouraged to use the administration chart included with each carton of DAYTRANA to monitor application and removal time, and method of disposal. The Medication Guide included at the end of this insert also includes a timetable to calculate when to remove DAYTRANA, based on the 9 hour application time.", "Patients or caregivers should avoid touching the adhesive side of the transdermal system during application, in order to avoid absorption of methylphenidate. If they do touch the adhesive side of the transdermal system, they should immediately wash their hands after application.", "In the event that a DAYTRANA does not fully adhere to the skin upon application, or is partially or fully detached during wear time, the transdermal system should be discarded according to the directions provided in this label, and a new transdermal system should be applied [see Dosage and Administration (2.3)]. If a transdermal system is replaced, the total recommended wear time for that day should remain 9 hours, regardless of the number of transdermal systems used.", "DAYTRANA should not be applied or re-applied with dressings, tape, or other common adhesives.", "Exposure to water during bathing, swimming, or showering can affect transdermal system adherence.", "Do not cut transdermal systems. Only intact transdermal systems should be applied.", "If there is an unacceptable duration of appetite loss or insomnia in the evening, taking the transdermal system off earlier may be attempted before decreasing the transdermal system dose.", "Skin redness or itching is common with DAYTRANA and small bumps on the skin may also occur in some patients. If any swelling or blistering occurs the DAYTRANA should not be worn and the patient should be seen by the prescriber. Patients or caregivers should not apply hydrocortisone or other solutions, creams, ointments, or emollients immediately prior to DAYTRANA application, since the effect on transdermal system adhesion and methylphenidate absorption has not been established. The potential adverse effects of topical corticosteroid use during treatment with DAYTRANA are unknown." ], "text": "" }

Recommended Storage Instructions

{ "type": "p", "children": [], "text": "\nRecommended Storage Instructions\n" }

Transdermal systems should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions permitted that do not exceed 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) [see How Supplied/Storage and Handling (16)]. Patients or caregivers should be advised not to store DAYTRANA in the refrigerator or freezer.

{ "type": "p", "children": [], "text": "Transdermal systems should be stored at 25 degrees Celsius (77 degrees Fahrenheit) with excursions permitted that do not exceed 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) [see How Supplied/Storage and Handling (16)]. Patients or caregivers should be advised not to store DAYTRANA in the refrigerator or freezer." }

Pregnancy Registry

{ "type": "p", "children": [], "text": "\nPregnancy Registry\n" }

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including DAYTRANA, during pregnancy [see Use in Specific Populations (8.1)]." }

Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.

{ "type": "p", "children": [], "text": "Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186." }

By: Noven Pharmaceuticals, Inc., Miami, FL 33186.

{ "type": "p", "children": [], "text": "By: Noven Pharmaceuticals, Inc., Miami, FL 33186." }

For more information, call 1-800-455-8070 or visit www.daytrana.com.

{ "type": "p", "children": [], "text": "For more information, call 1-800-455-8070 or visit www.daytrana.com." }

DOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc. DAYTRANA® is a registered trademark of Noven Therapeutics, LLC.

{ "type": "p", "children": [], "text": "\nDOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc. DAYTRANA® is a registered trademark of Noven Therapeutics, LLC.\n" }

102086-23

{ "type": "p", "children": [], "text": "102086-23" }

<div class="scrollingtable"><table width="100%"> <tfoot> <tr class="First First Last Last"> <td> <p class="First">This Medication Guide has been approved by the U.S. Food and Drug Administration.</p> </td><td></td><td align="right"> <p class="First">Revised 06/2025</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"><span class="Bold">MEDICATION GUIDE</span> <br/> <br/> <p class="First"> <span class="Bold">DAYTRANA<span class="Sup">®</span> (day-TRON-ah)</span> <br/> <span class="Bold">(methylphenidate transdermal system) CII</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">Important: DAYTRANA is for use on the skin only.</span></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">What is the most important information I should know about DAYTRANA?</span> <br/> <p class="First"> <span class="Bold">DAYTRANA may cause serious side effects, including:</span> </p> <ul> <li> <span class="Bold">Abuse, misuse, and addiction. </span>DAYTRANA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DAYTRANA, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DAYTRANA or when it is used in ways that are not approved, such as snorting or injection.<ul class="Circle"> <li>Your healthcare provider should check your child's risk for abuse, misuse, and addiction before starting treatment with DAYTRANA and will monitor your child during treatment.</li> <li>DAYTRANA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.</li> <li>Do not give DAYTRANA to anyone else. See "<span class="Bold">What is DAYTRANA?</span>" for more information.</li> <li>Keep DAYTRANA in a safe place and properly dispose of any unused medicine. See "<span class="Bold">How should I store DAYTRANA?</span>" for more information.</li> <li>Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.</li> </ul> </li> <li> <span class="Bold">Risks for people with serious heart disease.</span> Sudden death has happened in people who have heart defects or other serious heart disease.<br/>Your child's healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using DAYTRANA. Tell your child's healthcare provider if your child has any heart problems, heart disease or heart defects.<br/> <span class="Bold">Remove the DAYTRANA transdermal system (patch) and call your child's healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DAYTRANA.</span> </li> <li> <span class="Bold">Increased blood pressure and heart rate.</span> <br/>Your child's healthcare provider should check your child's blood pressure and heart rate regularly during treatment with DAYTRANA.</li> <li> <span class="Bold">Mental (psychiatric) problems, including:</span> <ul class="Circle"> <li>new or worse behavior or thought problems</li> <li>new or worse bipolar illness</li> <li>new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms</li> </ul>Tell your child's healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.<br/> <span class="Bold">Call your child's healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with DAYTRANA, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.</span> </li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">What Is DAYTRANA?</span> <br/> <p class="First">DAYTRANA is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. DAYTRANA may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD.</p> <p>It is not known if DAYTRANA is safe and effective in children younger than 6 years.</p> <p> <span class="Bold">DAYTRANA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep DAYTRANA in a safe place to protect it from theft.</span> Never give your DAYTRANA to anyone else because it may cause death or harm them. Selling or giving away DAYTRANA may harm others and is against the law.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">Do not use DAYTRANA if your child:</span> <ul> <li>is allergic to methylphenidate or any of the ingredients in DAYTRANA. See the end of this Medication Guide for a complete list of ingredients in DAYTRANA.</li> <li>is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">Before using DAYTRANA, tell your child's healthcare provider about all of your child's medical conditions, including if your child:</span> <br/> <ul> <li>has heart problems, heart disease, heart defects, or high blood pressure</li> <li>has mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide bipolar illness, or depression</li> <li>has seizures or have had an abnormal brain wave test (EEG)</li> <li>has circulation problems in fingers or toes</li> <li>has skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)</li> <li>has a history of vitiligo or a family history of vitiligo</li> <li>has eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)</li> <li>has or had repeated movements or sounds (tics) or Tourettes syndrome, or have a family history of tics or Tourettes syndrome</li> <li>is pregnant or plans to become pregnant. It is not known if DAYTRANA will harm the unborn baby. Tell your child's healthcare provider if your child becomes pregnant during treatment with DAYTRANA.<ul class="Circle"> <li>There is a pregnancy registry for females who are exposed to DAYTRANA during pregnancy. The purpose of the registry is to collect information about the health of women exposed to DAYTRANA and their baby. If your child becomes pregnant during treatment with DAYTRANA, talk to your child's healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at <a href="https://womensmentalhealth.org/adhd-medications/">https://womensmentalhealth.org/adhd-medications/</a>.</li> </ul> </li> <li>is breast feeding or plan to breast feed. DAYTRANA passes into breast milk. Talk to your child's healthcare provider about the best way to feed the baby during treatment with DAYTRANA.</li> <li>a history of vitiligo and/or a family history of vitiligo</li> </ul> <span class="Bold">Tell your child's healthcare provider about all of the medicines your child takes, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/> <p class="First">DAYTRANA and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with DAYTRANA. Your child's healthcare provider will decide if DAYTRANA can be taken with other medicines.</p> <p> <span class="Bold">Especially tell your child's healthcare provider if your child takes:</span> </p> <ul> <li>blood pressure medicines (anti-hypertensive)</li> </ul> <p>Know the medicines that your child takes. Keep a list of your child's medicines with you to show your child's healthcare provider and pharmacist when your child gets a new medicine. <span class="Bold">Do not start any new medicine while using DAYTRANA without first talking to your child's healthcare provider.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">How should DAYTRANA be used?</span> <br/> <ul> <li>See the detailed <span class="Bold">“Instructions for Use”</span> at the end of this Medication Guide for information about the right way to apply, remove, and dispose of DAYTRANA.</li> <li>Use DAYTRANA exactly as prescribed by your child's healthcare provider.</li> <li>Your child's healthcare provider may change the dose if needed.</li> <li>Apply DAYTRANA to the hip area 2 hours before an effect is needed and remove DAYTRANA within 9 hours after it is applied. <span class="Bold">Do not</span> wear DAYTRANA longer than 9 hours a day.</li> <li>If DAYTRANA falls off, a new patch may be applied to a different area of the same hip.</li> <li>If you forget to apply DAYTRANA at your usual scheduled time each day, you may apply the patch later in the day. The patch should be removed at the usual time of day to lower the chance of side effects later in the day.</li> <li>If your child has loss of appetite or trouble sleeping in the evening, ask your child's healthcare provider if your child can take the patch off earlier in the day.</li> <li>Contact with water while bathing, swimming, or showering can make the patch not stick well.</li> <li> <span class="Bold">Do not</span> use bandages, tape, or other household adhesives (glue) to hold the patch onto the skin.</li> </ul>If your child uses too much DAYTRANA transdermal systems call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">What should your child avoid while using DAYTRANA?</span> <br/> <ul> <li>After applying the DAYTRANA patch, avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds or other heat sources. Exposure to heat can cause too much medicine to pass into the body and cause serious side effects.</li> </ul> </td> </tr> <tr> <td class="Lrule Rrule Toprule" colspan="3"><span class="Bold">What are the possible side effects of DAYTRANA?</span> <p class="First"> <span class="Bold">DAYTRANA may cause serious side effects, including:</span> </p> <ul> <li>See <span class="Bold">"What is the most important information I should know about DAYTRANA?"</span> </li> <li> <span class="Bold">Seizures.</span> Your child's healthcare provider may stop treatment with DAYTRANA if your child has a seizure.</li> <li> <span class="Bold">Painful and prolonged erections (priapism).</span> Priapism that may require surgery has happened in people who take products that contain methylphenidate. <span class="Bold">If your child develops priapism, get medical help right away.</span> </li> <li> <span class="Bold">Circulation problems in fingers and toes (peripheral vasculopathy, including Raynauds phenomenon). Signs and symptoms may include:</span> <ul class="Circle"> <li>fingers or toes may feel numb, cool, or painful</li> <li>fingers and toes may change color from pale, to blue, to red</li> </ul>Tell your child's healthcare provider if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.<br/> <span class="Bold">Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with DAYTRANA.</span> </li> <li> <span class="Bold">Slowing of growth (height and weight) in children.</span> Your child should have their height and weight checked often during treatment with DAYTRANA. Your healthcare provider may stop your child’s DAYTRANA treatment if they are not growing or gaining weight as expected.</li> <li> <span class="Bold">Eyes problems (increased pressure in the eye and glaucoma).</span> Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.</li> <li> <span class="Bold">New or worsening tics or worsening Tourette's syndrome.</span> Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourettes syndrome during treatment with DAYTRANA.</li> <li> <span class="Bold">Loss of skin color.</span> DAYTRANA may cause a persistent loss of skin-color where the patch is applied or around the patch application site. Loss of skin-color, in some cases, has been reported at locations on the skin far from any application site. The loss of skin-color may be permanent even after removing the patch or DAYTRANA is stopped. Call your healthcare provider right away if your child has changes in skin-color. DAYTRANA treatment may be stopped if your child has changes in skin color.</li> <li> <span class="Bold">Allergic skin rash (contact sensitization).</span> Stop using DAYTRANA and tell your child's healthcare provider right away if your child develops swelling or blisters at or around the application site. Your child may have a skin allergy to DAYTRANA. People who have skin allergies to DAYTRANA may develop an allergy to all medicines that contain methylphenidate, even methylphenidate medicines taken by mouth.</li> </ul> </td> </tr> <tr> <td class="Lrule Rrule" colspan="3"><span class="Bold">The most common side effects of DAYTRANA in children 6 to 12 years old include:</span></td> </tr> <tr> <td class="Lrule"> <ul> <li>decreased appetite</li> <li>trouble sleeping</li> <li>nausea</li> </ul> </td><td valign="top"> <ul> <li>vomiting</li> <li>weight loss</li> <li>tics</li> </ul> </td><td class="Rrule" valign="top"> <ul> <li>changes in mood</li> <li>trouble eating</li> </ul> </td> </tr> <tr> <td class="Lrule Rrule" colspan="3"><span class="Bold">The most common side effects of DAYTRANA in children 13 to 17 years old include:</span></td> </tr> <tr> <td class="Lrule"> <ul> <li>decreased appetite</li> <li>nausea</li> <li>trouble sleeping</li> </ul> </td><td valign="top"> <ul> <li>weight loss</li> <li>dizziness</li> </ul> </td><td class="Rrule" valign="top"> <ul> <li>stomach pain</li> <li>trouble eating</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3"> <p class="First">DAYTRANA may also cause skin problems where it is applied (redness, small bumps, itching)</p> <p> <span class="Bold">Your child's doctor may do certain blood tests while your child uses DAYTRANA.</span> </p> <p>These are not all the possible side effects of DAYTRANA.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">How should I store DAYTRANA?</span> <br/> <ul> <li>Store DAYTRANA at room temperature between 68° F to 77° F (20° C to 25° C).</li> <li>Store DAYTRANA in a safe place, like a locked cabinet.</li> <li>Do not store DAYTRANA in the refrigerator or freezer.</li> <li>Keep DAYTRANA in their unopened pouches until you are ready to use them.</li> <li>Use or throw away the patches within 2 months after you open the sealed tray.</li> <li>Dispose of remaining, unused, or expired DAYTRANA by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, each unused patch should be removed from its individual pouch, separated from the protective liner, folded in half so that the sticky sides stick together, and flushed down the toilet. Put the pouch and liner in a container with a lid, close the container and throw away the container in the household trash. Do not flush the pouch and liner down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.</li> </ul> <span class="Bold">Keep DAYTRANA and all medicines out of the reach of children.</span></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">General information about the safe and effective use of DAYTRANA.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAYTRANA for a condition for which it was not prescribed. Do not give DAYTRANA to other people, even if they have the same symptoms. It may harm them and it is against the law.</p> <p>You can ask your pharmacist or healthcare provider for information about DAYTRANA that is written for healthcare professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="3"><span class="Bold">What are the ingredients in DAYTRANA?</span> <br/> <span class="Bold">Active ingredient:</span> methylphenidate<br/> <span class="Bold">Inactive ingredients: </span>acrylic adhesive, silicone adhesive<br/> <p class="First">Manufactured by: Noven Pharmaceuticals, Inc., Miami, FL 33186<br/>DAYTRANA<span class="Sup">®</span> is a trademark of Noven Therapeutics, LLC.</p> <p>For more information, go to www.daytrana.com, or call 1-800-455-8070.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tfoot>\n<tr class=\"First First Last Last\">\n<td>\n<p class=\"First\">This Medication Guide has been approved by the U.S. Food and Drug Administration.</p>\n</td><td></td><td align=\"right\">\n<p class=\"First\">Revised 06/2025</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"middle\"><span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>\n<br/>\n<p class=\"First\">\n<span class=\"Bold\">DAYTRANA<span class=\"Sup\">®</span> (day-TRON-ah)</span>\n<br/>\n<span class=\"Bold\">(methylphenidate transdermal system) CII</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">Important: DAYTRANA is for use on the skin only.</span></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">What is the most important information I should know about DAYTRANA?</span>\n<br/>\n<p class=\"First\">\n<span class=\"Bold\">DAYTRANA may cause serious side effects, including:</span>\n</p>\n<ul>\n<li>\n<span class=\"Bold\">Abuse, misuse, and addiction. </span>DAYTRANA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DAYTRANA, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DAYTRANA or when it is used in ways that are not approved, such as snorting or injection.<ul class=\"Circle\">\n<li>Your healthcare provider should check your child's risk for abuse, misuse, and addiction before starting treatment with DAYTRANA and will monitor your child during treatment.</li>\n<li>DAYTRANA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.</li>\n<li>Do not give DAYTRANA to anyone else. See \"<span class=\"Bold\">What is DAYTRANA?</span>\" for more information.</li>\n<li>Keep DAYTRANA in a safe place and properly dispose of any unused medicine. See \"<span class=\"Bold\">How should I store DAYTRANA?</span>\" for more information.</li>\n<li>Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Risks for people with serious heart disease.</span> Sudden death has happened in people who have heart defects or other serious heart disease.<br/>Your child's healthcare provider should check your child carefully for blood pressure and heart problems before starting treatment with and while you are using DAYTRANA. Tell your child's healthcare provider if your child has any heart problems, heart disease or heart defects.<br/>\n<span class=\"Bold\">Remove the DAYTRANA transdermal system (patch) and call your child's healthcare provider or go to the nearest emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DAYTRANA.</span>\n</li>\n<li>\n<span class=\"Bold\">Increased blood pressure and heart rate.</span>\n<br/>Your child's healthcare provider should check your child's blood pressure and heart rate regularly during treatment with DAYTRANA.</li>\n<li>\n<span class=\"Bold\">Mental (psychiatric) problems, including:</span>\n<ul class=\"Circle\">\n<li>new or worse behavior or thought problems</li>\n<li>new or worse bipolar illness</li>\n<li>new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or manic symptoms</li>\n</ul>Tell your child's healthcare provider about any mental problems your child has or about a family history of suicide, bipolar illness, or depression.<br/>\n<span class=\"Bold\">Call your child's healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with DAYTRANA, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">What Is DAYTRANA?</span>\n<br/>\n<p class=\"First\">DAYTRANA is a central nervous system (CNS) stimulant prescription medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. DAYTRANA may help increase attention and decrease impulsiveness and hyperactivity in children with ADHD.</p>\n<p>It is not known if DAYTRANA is safe and effective in children younger than 6 years.</p>\n<p>\n<span class=\"Bold\">DAYTRANA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep DAYTRANA in a safe place to protect it from theft.</span> Never give your DAYTRANA to anyone else because it may cause death or harm them. Selling or giving away DAYTRANA may harm others and is against the law.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">Do not use DAYTRANA if your child:</span>\n<ul>\n<li>is allergic to methylphenidate or any of the ingredients in DAYTRANA. See the end of this Medication Guide for a complete list of ingredients in DAYTRANA.</li>\n<li>is taking, or has stopped taking withing the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">Before using DAYTRANA, tell your child's healthcare provider about all of your child's medical conditions, including if your child:</span>\n<br/>\n<ul>\n<li>has heart problems, heart disease, heart defects, or high blood pressure</li>\n<li>has mental problems including psychosis, mania, bipolar illness, or depression, or has a family history of suicide bipolar illness, or depression</li>\n<li>has seizures or have had an abnormal brain wave test (EEG)</li>\n<li>has circulation problems in fingers or toes</li>\n<li>has skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives (glues)</li>\n<li>has a history of vitiligo or a family history of vitiligo</li>\n<li>has eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)</li>\n<li>has or had repeated movements or sounds (tics) or Tourettes syndrome, or have a family history of tics or Tourettes syndrome</li>\n<li>is pregnant or plans to become pregnant. It is not known if DAYTRANA will harm the unborn baby. Tell your child's healthcare provider if your child becomes pregnant during treatment with DAYTRANA.<ul class=\"Circle\">\n<li>There is a pregnancy registry for females who are exposed to DAYTRANA during pregnancy. The purpose of the registry is to collect information about the health of women exposed to DAYTRANA and their baby. If your child becomes pregnant during treatment with DAYTRANA, talk to your child's healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at <a href=\"https://womensmentalhealth.org/adhd-medications/\">https://womensmentalhealth.org/adhd-medications/</a>.</li>\n</ul>\n</li>\n<li>is breast feeding or plan to breast feed. DAYTRANA passes into breast milk. Talk to your child's healthcare provider about the best way to feed the baby during treatment with DAYTRANA.</li>\n<li>a history of vitiligo and/or a family history of vitiligo</li>\n</ul>\n<span class=\"Bold\">Tell your child's healthcare provider about all of the medicines your child takes, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/>\n<p class=\"First\">DAYTRANA and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with DAYTRANA. Your child's healthcare provider will decide if DAYTRANA can be taken with other medicines.</p>\n<p>\n<span class=\"Bold\">Especially tell your child's healthcare provider if your child takes:</span>\n</p>\n<ul>\n<li>blood pressure medicines (anti-hypertensive)</li>\n</ul>\n<p>Know the medicines that your child takes. Keep a list of your child's medicines with you to show your child's healthcare provider and pharmacist when your child gets a new medicine. <span class=\"Bold\">Do not start any new medicine while using DAYTRANA without first talking to your child's healthcare provider.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">How should DAYTRANA be used?</span>\n<br/>\n<ul>\n<li>See the detailed <span class=\"Bold\">“Instructions for Use”</span> at the end of this Medication Guide for information about the right way to apply, remove, and dispose of DAYTRANA.</li>\n<li>Use DAYTRANA exactly as prescribed by your child's healthcare provider.</li>\n<li>Your child's healthcare provider may change the dose if needed.</li>\n<li>Apply DAYTRANA to the hip area 2 hours before an effect is needed and remove DAYTRANA within 9 hours after it is applied. <span class=\"Bold\">Do not</span> wear DAYTRANA longer than 9 hours a day.</li>\n<li>If DAYTRANA falls off, a new patch may be applied to a different area of the same hip.</li>\n<li>If you forget to apply DAYTRANA at your usual scheduled time each day, you may apply the patch later in the day. The patch should be removed at the usual time of day to lower the chance of side effects later in the day.</li>\n<li>If your child has loss of appetite or trouble sleeping in the evening, ask your child's healthcare provider if your child can take the patch off earlier in the day.</li>\n<li>Contact with water while bathing, swimming, or showering can make the patch not stick well.</li>\n<li>\n<span class=\"Bold\">Do not</span> use bandages, tape, or other household adhesives (glue) to hold the patch onto the skin.</li>\n</ul>If your child uses too much DAYTRANA transdermal systems call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">What should your child avoid while using DAYTRANA?</span>\n<br/>\n<ul>\n<li>After applying the DAYTRANA patch, avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds or other heat sources. Exposure to heat can cause too much medicine to pass into the body and cause serious side effects.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">What are the possible side effects of DAYTRANA?</span>\n<p class=\"First\">\n<span class=\"Bold\">DAYTRANA may cause serious side effects, including:</span>\n</p>\n<ul>\n<li>See <span class=\"Bold\">\"What is the most important information I should know about DAYTRANA?\"</span>\n</li>\n<li>\n<span class=\"Bold\">Seizures.</span> Your child's healthcare provider may stop treatment with DAYTRANA if your child has a seizure.</li>\n<li>\n<span class=\"Bold\">Painful and prolonged erections (priapism).</span> Priapism that may require surgery has happened in people who take products that contain methylphenidate. <span class=\"Bold\">If your child develops priapism, get medical help right away.</span>\n</li>\n<li>\n<span class=\"Bold\">Circulation problems in fingers and toes (peripheral vasculopathy, including Raynauds phenomenon). Signs and symptoms may include:</span>\n<ul class=\"Circle\">\n<li>fingers or toes may feel numb, cool, or painful</li>\n<li>fingers and toes may change color from pale, to blue, to red</li>\n</ul>Tell your child's healthcare provider if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.<br/>\n<span class=\"Bold\">Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with DAYTRANA.</span>\n</li>\n<li>\n<span class=\"Bold\">Slowing of growth (height and weight) in children.</span> Your child should have their height and weight checked often during treatment with DAYTRANA. Your healthcare provider may stop your child’s DAYTRANA treatment if they are not growing or gaining weight as expected.</li>\n<li>\n<span class=\"Bold\">Eyes problems (increased pressure in the eye and glaucoma).</span> Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.</li>\n<li>\n<span class=\"Bold\">New or worsening tics or worsening Tourette's syndrome.</span> Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourettes syndrome during treatment with DAYTRANA.</li>\n<li>\n<span class=\"Bold\">Loss of skin color.</span> DAYTRANA may cause a persistent loss of skin-color where the patch is applied or around the patch application site. Loss of skin-color, in some cases, has been reported at locations on the skin far from any application site. The loss of skin-color may be permanent even after removing the patch or DAYTRANA is stopped. Call your healthcare provider right away if your child has changes in skin-color. DAYTRANA treatment may be stopped if your child has changes in skin color.</li>\n<li>\n<span class=\"Bold\">Allergic skin rash (contact sensitization).</span> Stop using DAYTRANA and tell your child's healthcare provider right away if your child develops swelling or blisters at or around the application site. Your child may have a skin allergy to DAYTRANA. People who have skin allergies to DAYTRANA may develop an allergy to all medicines that contain methylphenidate, even methylphenidate medicines taken by mouth.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"3\"><span class=\"Bold\">The most common side effects of DAYTRANA in children 6 to 12 years old include:</span></td>\n</tr>\n<tr>\n<td class=\"Lrule\">\n<ul>\n<li>decreased appetite</li>\n<li>trouble sleeping</li>\n<li>nausea</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>vomiting</li>\n<li>weight loss</li>\n<li>tics</li>\n</ul>\n</td><td class=\"Rrule\" valign=\"top\">\n<ul>\n<li>changes in mood</li>\n<li>trouble eating</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"3\"><span class=\"Bold\">The most common side effects of DAYTRANA in children 13 to 17 years old include:</span></td>\n</tr>\n<tr>\n<td class=\"Lrule\">\n<ul>\n<li>decreased appetite</li>\n<li>nausea</li>\n<li>trouble sleeping</li>\n</ul>\n</td><td valign=\"top\">\n<ul>\n<li>weight loss</li>\n<li>dizziness</li>\n</ul>\n</td><td class=\"Rrule\" valign=\"top\">\n<ul>\n<li>stomach pain</li>\n<li>trouble eating</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\">\n<p class=\"First\">DAYTRANA may also cause skin problems where it is applied (redness, small bumps, itching)</p>\n<p>\n<span class=\"Bold\">Your child's doctor may do certain blood tests while your child uses DAYTRANA.</span>\n</p>\n<p>These are not all the possible side effects of DAYTRANA.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">How should I store DAYTRANA?</span>\n<br/>\n<ul>\n<li>Store DAYTRANA at room temperature between 68° F to 77° F (20° C to 25° C).</li>\n<li>Store DAYTRANA in a safe place, like a locked cabinet.</li>\n<li>Do not store DAYTRANA in the refrigerator or freezer.</li>\n<li>Keep DAYTRANA in their unopened pouches until you are ready to use them.</li>\n<li>Use or throw away the patches within 2 months after you open the sealed tray.</li>\n<li>Dispose of remaining, unused, or expired DAYTRANA by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, each unused patch should be removed from its individual pouch, separated from the protective liner, folded in half so that the sticky sides stick together, and flushed down the toilet. Put the pouch and liner in a container with a lid, close the container and throw away the container in the household trash. Do not flush the pouch and liner down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.</li>\n</ul>\n<span class=\"Bold\">Keep DAYTRANA and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of DAYTRANA.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAYTRANA for a condition for which it was not prescribed. Do not give DAYTRANA to other people, even if they have the same symptoms. It may harm them and it is against the law.</p>\n<p>You can ask your pharmacist or healthcare provider for information about DAYTRANA that is written for healthcare professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\"><span class=\"Bold\">What are the ingredients in DAYTRANA?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> methylphenidate<br/>\n<span class=\"Bold\">Inactive ingredients: </span>acrylic adhesive, silicone adhesive<br/>\n<p class=\"First\">Manufactured by: Noven Pharmaceuticals, Inc., Miami, FL 33186<br/>DAYTRANA<span class=\"Sup\">®</span> is a trademark of Noven Therapeutics, LLC.</p>\n<p>For more information, go to www.daytrana.com, or call 1-800-455-8070.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First First Last Last"> <td align="center"><span class="Bold">INSTRUCTIONS FOR USE</span> <br/> <span class="Bold">DAYTRANA<span class="Sup">®</span> (day-TRON-ah)</span> <br/> <span class="Bold">(methylphenidate transdermal system) CII</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td align=\"center\"><span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n<br/>\n<span class=\"Bold\">DAYTRANA<span class=\"Sup\">®</span> (day-TRON-ah)</span>\n<br/>\n<span class=\"Bold\">(methylphenidate transdermal system) CII</span></td>\n</tr>\n</tbody>\n</table></div>" }

1. DAYTRANA Dosing Chart

{ "type": "p", "children": [], "text": "\n1. DAYTRANA Dosing Chart\n" }

Each carton of DAYTRANA contains a DAYTRANA Dosing Chart to help you keep track of your DAYTRANA transdermal system (patch) including:

{ "type": "p", "children": [], "text": "Each carton of DAYTRANA contains a DAYTRANA Dosing Chart to help you keep track of your DAYTRANA transdermal system (patch) including:" }

{ "type": "ul", "children": [ "when you apply patch to the skin on your hip each morning", "when you remove the patch", "how and where you threw DAYTRANA away" ], "text": "" }

To use the DAYTRANA Dosing Chart, follow these instructions:

{ "type": "p", "children": [], "text": "To use the DAYTRANA Dosing Chart, follow these instructions:" }

{ "type": "ul", "children": [ "Each day, when a new patch is applied to your hip, write down the date and time that you applied the patch.", "Use the DAYTRANA schedule below so you can decide when to remove the patch. For example, if the patch is applied to the skin at 6:00 a.m., remove the patch at 3:00 p.m. on the same day. After you remove and throw away the patch, write down the time you removed the patch and how and where you threw it away.", "If the patch you placed on your child is missing, ask your child:\nwhen the patch came off\nhow the patch came off\nwhere the patch is\n\n" ], "text": "" }

DAYTRANA Schedule for 9 Hour Dosing

{ "type": "p", "children": [], "text": "\nDAYTRANA Schedule for 9 Hour Dosing\n" }

<div class="scrollingtable"><table width="700px"> <colgroup> <col align="left" width="50%"/> <col align="left" width="50%"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule" valign="top"><span class="Bold">If you put the patch on at:</span></td><td align="left" class="Botrule" valign="top"><span class="Bold">On the same day, remove the patch at:</span></td> </tr> <tr> <td align="left" class="Botrule">5:00 a.m.</td><td align="left" class="Botrule">2:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">6:00 a.m.</td><td align="left" class="Botrule">3:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">7:00 a.m.</td><td align="left" class="Botrule">4:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">8:00 a.m.</td><td align="left" class="Botrule">5:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">9:00 a.m.</td><td align="left" class="Botrule">6:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">10:00 a.m.</td><td align="left" class="Botrule">7:00 p.m.</td> </tr> <tr> <td align="left" class="Botrule">11:00 a.m.</td><td align="left" class="Botrule">8:00 p.m.</td> </tr> <tr class="Last"> <td align="left" class="Botrule">12:00 p.m.</td><td align="left" class="Botrule">9:00 p.m.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"700px\">\n<colgroup>\n<col align=\"left\" width=\"50%\"/>\n<col align=\"left\" width=\"50%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">If you put the patch on at:</span></td><td align=\"left\" class=\"Botrule\" valign=\"top\"><span class=\"Bold\">On the same day, remove the patch at:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">5:00 a.m.</td><td align=\"left\" class=\"Botrule\">2:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">6:00 a.m.</td><td align=\"left\" class=\"Botrule\">3:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">7:00 a.m.</td><td align=\"left\" class=\"Botrule\">4:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">8:00 a.m.</td><td align=\"left\" class=\"Botrule\">5:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">9:00 a.m.</td><td align=\"left\" class=\"Botrule\">6:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">10:00 a.m.</td><td align=\"left\" class=\"Botrule\">7:00 p.m.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\">11:00 a.m.</td><td align=\"left\" class=\"Botrule\">8:00 p.m.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule\">12:00 p.m.</td><td align=\"left\" class=\"Botrule\">9:00 p.m.</td>\n</tr>\n</tbody>\n</table></div>" }

2. Where to apply DAYTRANA

{ "type": "p", "children": [], "text": "\n2. Where to apply DAYTRANA\n" }

{ "type": "ul", "children": [ "Apply patch to your hip area. Do not put the patch near your waist. Clothing and movement may make your patch rub off (See Figure A).", "Use your other hip when you apply a new patch the next morning. Make sure there is no redness, small bumps or itching at the site where the patch is going to be applied." ], "text": "" }

{ "type": "", "children": [], "text": "" }

3. Before you apply DAYTRANA

{ "type": "p", "children": [], "text": "\n3. Before you apply DAYTRANA \n" }

Make sure your skin:

{ "type": "p", "children": [], "text": "Make sure your skin:" }

{ "type": "ul", "children": [ "Is clean (freshly washed), dry, and cool", "Does not have any powder, oil, or lotion", "Does not have any cuts and irritation (rashes, inflammation, redness, or other skin problems)." ], "text": "" }

4. How to apply DAYTRANA

{ "type": "p", "children": [], "text": "\n4. How to apply DAYTRANA\n" }

{ "type": "ul", "children": [ "Open the sealed tray and throw away the small packet (drying agent).", "Each patch is sealed in its own protective pouch.", "Carefully cut the protective pouch open with scissors, being careful not to cut the patch. Do not use patches that have been cut or damaged in any way (See Figure B).\n" ], "text": "" }

Figure B

{ "type": "p", "children": [], "text": "\nFigure B\n" }

{ "type": "ul", "children": [ "Remove the patch from the protective pouch.", "Look at the patch to make sure it is not damaged. The patch should separate easily from the protective liner. Throw away the patch if the protective liner is hard to remove." ], "text": "" }

DAYTRANA has 3 layers. The 3 layers are pictured below. The pictures show both sides of the patch: 

{ "type": "p", "children": [], "text": "DAYTRANA has 3 layers. The 3 layers are pictured below. The pictures show both sides of the patch: " }

                         Figure C                                                                  Figure D

{ "type": "p", "children": [], "text": "\n                         Figure C                                                                  Figure D\n" }

Layers:

{ "type": "p", "children": [], "text": "\nLayers:\n" }

{ "type": "ul", "children": [ "\nProtective liner: The protective liner is the layer that you remove before you put the patch on (See Figure C).", "\nAdhesive with medicine: The adhesive with medicine is the layer that sticks to your skin (See Figure C).", "\nOutside backing: The outside backing is the layer that you see after you put the patch on your skin. The word \"Daytrana\" is printed on this layer (See Figure D)." ], "text": "" }

{ "type": "ul", "children": [ "\nApply the patch right away after you remove the patch from protective pouch.", "Hold the patch with the hard protective liner facing you. The word DAYTRANA will appear backwards.", "\nGently bend the patch along the faint line and slowly peel half the liner, which covers the sticky surface of the patch (See Figure E)." ], "text": "" }

Figure E

{ "type": "p", "children": [], "text": "\nFigure E\n" }

{ "type": "ul", "children": [ "Avoid touching the sticky side of the patch with your fingers.", "If you accidentally touch the sticky side of the patch, apply the patch, then wash your hands right away so that the medicine does not go into the skin on your hands.", "Using the other half of the protective liner as a handle, apply the sticky side of the patch to the selected area of the child's hip (See Figure F)." ], "text": "" }

Figure F

{ "type": "p", "children": [], "text": "\nFigure F\n" }

{ "type": "ul", "children": [ "Press the sticky side of the patch firmly into place and smooth it down.", "While you are still holding the sticky side down, gently fold back the other half of the patch.", "Hold an edge of the remaining protective liner and slowly peel it off (See Figure G)." ], "text": "" }

Figure G

{ "type": "p", "children": [], "text": "\nFigure G\n" }

{ "type": "ul", "children": [ "After the protective liner is removed, there should not be any adhesive (glue) sticking to the liner." ], "text": "" }

Figure H

{ "type": "p", "children": [], "text": "\nFigure H\n" }

{ "type": "ul", "children": [ "\nPress the entire patch firmly into place with the palm of your hand over the patch for about 30 seconds (See Figure H).\n", "Make sure that the patch firmly sticks to your skin.", "Gently rub the edges of the patch with your fingers to make sure the patch sticks to your skin.", "Wash your hands after you apply your patch.", "Write the time you applied your patch on the dosing chart on the carton. Use the dosing schedule so you know what time you should remove your patch." ], "text": "" }

5. How to remove and throw away DAYTRANA

{ "type": "p", "children": [], "text": "\n5. How to remove and throw away DAYTRANA\n" }

{ "type": "ul", "children": [ "When you remove the patch, peel it off slowly. If the patch is too sticky on your skin and you need something to help you remove it:\nGently apply an oil-based product (petroleum jelly, olive oil, or mineral oil) to the patch edges. Gently spread the oil underneath the patch edges.\nApply an oil-based product or lotion to your skin if any adhesive (glue) remains after you remove your patch. This will gently loosen and remove any adhesive that is left over.\nIf you still cannot easily remove the patch, ask your doctor or pharmacist about what to do for this problem.\n\n", "Fold the used patch in half and press it together firmly so that the sticky side sticks to itself. Flush the used patch down the toilet.\n", "Do not flush the protective pouches or the protective liners down the toilet. These items should be thrown away in a container with a lid.", "Wash your hands after you handle the patch.", "After you remove the patch and throw the patch away, write down the time on the dosing chart.", "Safely throw away any unused patches that are left over from the prescription as soon as they are no longer needed. To safely throw away the patches:\nRemove the leftover patches from their protective pouches and remove the protective liners.\nEither fold the patches in half with the sticky sides together, and flush the patches down the toilet, or\n\nDispose of remaining, unused, or expired DAYTRANA by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, each unused patch should be removed from its individual pouch, separated from the protective liner, folded in half so that the sticky sides stick together, and flushed down the toilet. Put the pouch and liner in a container with a lid, close the container and throw away the container in the household trash. Do not flush the pouch and liner down the toilet. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.\n\n" ], "text": "" }

Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186.

{ "type": "p", "children": [], "text": "Manufactured for: Noven Therapeutics, LLC, Miami, FL 33186." }

By: Noven Pharmaceuticals, Inc., Miami, FL 33186.This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "By: Noven Pharmaceuticals, Inc., Miami, FL 33186.This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Revised: 06/2025

{ "type": "p", "children": [], "text": "Revised: 06/2025" }

102086-23

{ "type": "p", "children": [], "text": "102086-23" }

PRINCIPAL DISPLAY PANEL - NDC 68968-5552-3 - 10 mg 30 Count Carton

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - NDC 68968-5552-3 - 10 mg 30 Count Carton\n" }

NDC 68968-5552-3

{ "type": "p", "children": [], "text": "\nNDC 68968-5552-3\n" }

Daytrana®

{ "type": "p", "children": [], "text": "\nDaytrana®\n" }

(methylphenidate transdermal system)

{ "type": "p", "children": [], "text": "\n(methylphenidate transdermal system)\n" }

Delivers 10 mg over 9 hours

{ "type": "p", "children": [], "text": "\nDelivers 10 mg over 9 hours\n" }

(1.1 mg/hr)

{ "type": "p", "children": [], "text": "\n(1.1 mg/hr)\n" }

Patch should be worn for approximately 9 hours

{ "type": "p", "children": [], "text": "\nPatch should be worn for approximately 9 hours\n" }

Contains: 30 Patches

{ "type": "p", "children": [], "text": "\nContains: 30 Patches\n" }

CII

{ "type": "p", "children": [], "text": "\nCII\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

Noven Therapeutics, LLC

{ "type": "p", "children": [], "text": "Noven Therapeutics, LLC" }

Once the tray is opened, use contents within 2 months.

{ "type": "p", "children": [], "text": "\nOnce the tray is opened, use contents within 2 months.\n" }

Manufactured for Noven Therapeutics, LLC, Miami, FL 33186

{ "type": "p", "children": [], "text": "Manufactured for Noven Therapeutics, LLC, Miami, FL 33186" }

By Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "By Noven Pharmaceuticals, Inc." }

©2007, 2010 Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "©2007, 2010 Noven Pharmaceuticals, Inc." }

1-877-567-7857

{ "type": "p", "children": [], "text": "1-877-567-7857" }

Pharmacists: Enclosed Medication Guide to be dispensed to each patient.

{ "type": "p", "children": [], "text": "\nPharmacists: Enclosed Medication Guide to be dispensed to each patient.\n" }

302188-8 Rev. 9/2016

{ "type": "p", "children": [], "text": "\n302188-8 Rev. 9/2016\n" }

Each patch contains 27.5 mg of methylphenidate.

{ "type": "p", "children": [], "text": "\nEach patch contains 27.5 mg of methylphenidate.\n" }

Active ingredient release is limited; please see recommended dosing in patient instructions.

{ "type": "p", "children": [], "text": "Active ingredient release is limited; please see recommended dosing in patient instructions." }

Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive.

{ "type": "p", "children": [], "text": "Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive." }

For transdermal use only (applied only to skin).

{ "type": "p", "children": [], "text": "For transdermal use only (applied only to skin)." }

Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch.

{ "type": "p", "children": [], "text": "Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch." }

Do not store unpouched. Do not store patches in refrigerators or freezers.

{ "type": "p", "children": [], "text": "Do not store unpouched. Do not store patches in refrigerators or freezers." }

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]

{ "type": "p", "children": [], "text": "Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]" }

Important: Keep out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep out of the reach of children.\n" }

It is important that this product be disposed of properly. See patient instructions for disposal information.

{ "type": "p", "children": [], "text": "\nIt is important that this product be disposed of properly. See patient instructions for disposal information.\n" }

Dosage and Administration: See package insert.

{ "type": "p", "children": [], "text": "\nDosage and Administration: See package insert." }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Rrule"> <p class="First">Date of Patch Application</p> <p>MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied</td><td align="center" class="Botrule Lrule Rrule">Time Removed</td><td align="center" class="Botrule Lrule Rrule">Application Side</td><td align="center" class="Botrule Lrule Rrule">Disposal Method</td><td align="center" class="Botrule Lrule Rrule">Date of Patch Application<p class="First">MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied </td><td align="center" class="Botrule Lrule Rrule">Time Removed </td><td align="center" class="Botrule Lrule Rrule">Application Side </td><td align="center" class="Botrule Lrule">Disposal Method </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Rrule\">\n<p class=\"First\">Date of Patch Application</p>\n<p>MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Disposal Method</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Date of Patch Application<p class=\"First\">MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side </td><td align=\"center\" class=\"Botrule Lrule\">Disposal Method </td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

PRINCIPAL DISPLAY PANEL - NDC 68968-5553-3 - 15 mg 30 Count Carton

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - NDC 68968-5553-3 - 15 mg 30 Count Carton\n" }

NDC 68968-5553-3

{ "type": "p", "children": [], "text": "\nNDC 68968-5553-3\n" }

Daytrana®

{ "type": "p", "children": [], "text": "\nDaytrana®\n" }

(methylphenidate transdermal system)

{ "type": "p", "children": [], "text": "\n(methylphenidate transdermal system)\n" }

Delivers 15 mg over 9 hours

{ "type": "p", "children": [], "text": "\nDelivers 15 mg over 9 hours\n" }

(1.6 mg/hr)

{ "type": "p", "children": [], "text": "\n(1.6 mg/hr)\n" }

Patch should be worn for approximately 9 hours

{ "type": "p", "children": [], "text": "\nPatch should be worn for approximately 9 hours\n" }

Contains: 30 Patches

{ "type": "p", "children": [], "text": "\nContains: 30 Patches\n" }

CII

{ "type": "p", "children": [], "text": "\nCII\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

Noven Therapeutics, LLC

{ "type": "p", "children": [], "text": "Noven Therapeutics, LLC" }

Once the tray is opened, use contents within 2 months.

{ "type": "p", "children": [], "text": "\nOnce the tray is opened, use contents within 2 months.\n" }

Manufactured for Noven Therapeutics, LLC, Miami, FL 33186

{ "type": "p", "children": [], "text": "Manufactured for Noven Therapeutics, LLC, Miami, FL 33186" }

By Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "By Noven Pharmaceuticals, Inc." }

©2007, 2010 Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "©2007, 2010 Noven Pharmaceuticals, Inc." }

1-877-567-7857

{ "type": "p", "children": [], "text": "1-877-567-7857" }

Pharmacists: Enclosed Medication Guide to be dispensed to each patient.

{ "type": "p", "children": [], "text": "\nPharmacists: Enclosed Medication Guide to be dispensed to each patient.\n" }

302189-8 Rev. 9/2016

{ "type": "p", "children": [], "text": "\n302189-8 Rev. 9/2016\n" }

Each patch contains 41.3 mg of methylphenidate.

{ "type": "p", "children": [], "text": "\nEach patch contains 41.3 mg of methylphenidate.\n" }

Active ingredient release is limited; please see recommended dosing in patient instructions.

{ "type": "p", "children": [], "text": "Active ingredient release is limited; please see recommended dosing in patient instructions." }

Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive.

{ "type": "p", "children": [], "text": "Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive." }

For transdermal use only (applied only to skin).

{ "type": "p", "children": [], "text": "For transdermal use only (applied only to skin)." }

Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch.

{ "type": "p", "children": [], "text": "Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch." }

Do not store unpouched. Do not store patches in refrigerators or freezers.

{ "type": "p", "children": [], "text": "Do not store unpouched. Do not store patches in refrigerators or freezers." }

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]

{ "type": "p", "children": [], "text": "Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]" }

Important: Keep out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep out of the reach of children.\n" }

It is important that this product be disposed of properly. See patient instructions for disposal information.

{ "type": "p", "children": [], "text": "\nIt is important that this product be disposed of properly. See patient instructions for disposal information.\n" }

Dosage and Administration: See package insert.

{ "type": "p", "children": [], "text": "\nDosage and Administration: See package insert." }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Rrule"> <p class="First">Date of Patch Application</p> <p>MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied</td><td align="center" class="Botrule Lrule Rrule">Time Removed</td><td align="center" class="Botrule Lrule Rrule">Application Side</td><td align="center" class="Botrule Lrule Rrule">Disposal Method</td><td align="center" class="Botrule Lrule Rrule">Date of Patch Application<p class="First">MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied </td><td align="center" class="Botrule Lrule Rrule">Time Removed </td><td align="center" class="Botrule Lrule Rrule">Application Side </td><td align="center" class="Botrule Lrule">Disposal Method </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Rrule\">\n<p class=\"First\">Date of Patch Application</p>\n<p>MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Disposal Method</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Date of Patch Application<p class=\"First\">MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side </td><td align=\"center\" class=\"Botrule Lrule\">Disposal Method </td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

PRINCIPAL DISPLAY PANEL - NDC 68968-5554-3 - 20 mg 30 Count Carton

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - NDC 68968-5554-3 - 20 mg 30 Count Carton\n" }

NDC 68968-5554-3

{ "type": "p", "children": [], "text": "\nNDC 68968-5554-3\n" }

Daytrana®

{ "type": "p", "children": [], "text": "\nDaytrana®\n" }

(methylphenidate transdermal system)

{ "type": "p", "children": [], "text": "\n(methylphenidate transdermal system)\n" }

Delivers 20 mg over 9 hours

{ "type": "p", "children": [], "text": "\nDelivers 20 mg over 9 hours\n" }

(2.2 mg/hr)

{ "type": "p", "children": [], "text": "\n(2.2 mg/hr)\n" }

Patch should be worn for approximately 9 hours

{ "type": "p", "children": [], "text": "\nPatch should be worn for approximately 9 hours\n" }

Contains: 30 Patches

{ "type": "p", "children": [], "text": "\nContains: 30 Patches\n" }

CII

{ "type": "p", "children": [], "text": "\nCII\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

Noven Therapeutics, LLC

{ "type": "p", "children": [], "text": "Noven Therapeutics, LLC" }

Once the tray is opened, use contents within 2 months.

{ "type": "p", "children": [], "text": "\nOnce the tray is opened, use contents within 2 months.\n" }

Manufactured for Noven Therapeutics, LLC, Miami, FL 33186

{ "type": "p", "children": [], "text": "Manufactured for Noven Therapeutics, LLC, Miami, FL 33186" }

By Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "By Noven Pharmaceuticals, Inc." }

©2007, 2010 Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "©2007, 2010 Noven Pharmaceuticals, Inc." }

1-877-567-7857

{ "type": "p", "children": [], "text": "1-877-567-7857" }

Pharmacists: Enclosed Medication Guide to be dispensed to each patient.

{ "type": "p", "children": [], "text": "\nPharmacists: Enclosed Medication Guide to be dispensed to each patient.\n" }

302190-8 Rev. 9/2016

{ "type": "p", "children": [], "text": "\n302190-8 Rev. 9/2016\n" }

Each patch contains 55 mg of methylphenidate.

{ "type": "p", "children": [], "text": "\nEach patch contains 55 mg of methylphenidate.\n" }

Active ingredient release is limited; please see recommended dosing in patient instructions.

{ "type": "p", "children": [], "text": "Active ingredient release is limited; please see recommended dosing in patient instructions." }

Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive.

{ "type": "p", "children": [], "text": "Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive." }

For transdermal use only (applied only to skin).

{ "type": "p", "children": [], "text": "For transdermal use only (applied only to skin)." }

Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch.

{ "type": "p", "children": [], "text": "Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch." }

Do not store unpouched. Do not store patches in refrigerators or freezers.

{ "type": "p", "children": [], "text": "Do not store unpouched. Do not store patches in refrigerators or freezers." }

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]

{ "type": "p", "children": [], "text": "Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]" }

Important: Keep out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep out of the reach of children.\n" }

It is important that this product be disposed of properly. See patient instructions for disposal information.

{ "type": "p", "children": [], "text": "\nIt is important that this product be disposed of properly. See patient instructions for disposal information.\n" }

Dosage and Administration: See package insert.

{ "type": "p", "children": [], "text": "\nDosage and Administration: See package insert." }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Rrule"> <p class="First">Date of Patch Application</p> <p>MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied</td><td align="center" class="Botrule Lrule Rrule">Time Removed</td><td align="center" class="Botrule Lrule Rrule">Application Side</td><td align="center" class="Botrule Lrule Rrule">Disposal Method</td><td align="center" class="Botrule Lrule Rrule">Date of Patch Application<p class="First">MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied </td><td align="center" class="Botrule Lrule Rrule">Time Removed </td><td align="center" class="Botrule Lrule Rrule">Application Side </td><td align="center" class="Botrule Lrule">Disposal Method </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Rrule\">\n<p class=\"First\">Date of Patch Application</p>\n<p>MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Disposal Method</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Date of Patch Application<p class=\"First\">MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side </td><td align=\"center\" class=\"Botrule Lrule\">Disposal Method </td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

PRINCIPAL DISPLAY PANEL - NDC 68968-5555-3 - 30 mg 30 Count Carton

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - NDC 68968-5555-3 - 30 mg 30 Count Carton\n" }

NDC 68968-5555-3

{ "type": "p", "children": [], "text": "\nNDC 68968-5555-3\n" }

Daytrana®

{ "type": "p", "children": [], "text": "\nDaytrana®\n" }

(methylphenidate transdermal system)

{ "type": "p", "children": [], "text": "\n(methylphenidate transdermal system)\n" }

Delivers 30 mg over 9 hours

{ "type": "p", "children": [], "text": "\nDelivers 30 mg over 9 hours\n" }

(3.3 mg/hr)

{ "type": "p", "children": [], "text": "\n(3.3 mg/hr)\n" }

Patch should be worn for approximately 9 hours

{ "type": "p", "children": [], "text": "\nPatch should be worn for approximately 9 hours\n" }

Contains: 30 Patches

{ "type": "p", "children": [], "text": "\nContains: 30 Patches\n" }

CII

{ "type": "p", "children": [], "text": "\nCII\n" }

Rx only

{ "type": "p", "children": [], "text": "\nRx only\n" }

Noven Therapeutics, LLC

{ "type": "p", "children": [], "text": "Noven Therapeutics, LLC" }

Once the tray is opened, use contents within 2 months.

{ "type": "p", "children": [], "text": "\nOnce the tray is opened, use contents within 2 months.\n" }

Manufactured for Noven Therapeutics, LLC, Miami, FL 33186

{ "type": "p", "children": [], "text": "Manufactured for Noven Therapeutics, LLC, Miami, FL 33186" }

By Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "By Noven Pharmaceuticals, Inc." }

©2007, 2010 Noven Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "©2007, 2010 Noven Pharmaceuticals, Inc." }

1-877-567-7857

{ "type": "p", "children": [], "text": "1-877-567-7857" }

Pharmacists: Enclosed Medication Guide to be dispensed to each patient.

{ "type": "p", "children": [], "text": "\nPharmacists: Enclosed Medication Guide to be dispensed to each patient.\n" }

302191-8 Rev. 9/2016

{ "type": "p", "children": [], "text": "\n302191-8 Rev. 9/2016\n" }

Each patch contains 82.5 mg of methylphenidate.

{ "type": "p", "children": [], "text": "\nEach patch contains 82.5 mg of methylphenidate.\n" }

Active ingredient release is limited; please see recommended dosing in patient instructions.

{ "type": "p", "children": [], "text": "Active ingredient release is limited; please see recommended dosing in patient instructions." }

Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive.

{ "type": "p", "children": [], "text": "Inactive components: acrylic adhesive, coextruded backing film, polyester release liner and silicone adhesive." }

For transdermal use only (applied only to skin).

{ "type": "p", "children": [], "text": "For transdermal use only (applied only to skin)." }

Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch.

{ "type": "p", "children": [], "text": "Keep all patches within provided containers and dispense one patch daily. Apply immediately upon removal from pouch." }

Do not store unpouched. Do not store patches in refrigerators or freezers.

{ "type": "p", "children": [], "text": "Do not store unpouched. Do not store patches in refrigerators or freezers." }

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]

{ "type": "p", "children": [], "text": "Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled Room Temperature]" }

Important: Keep out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep out of the reach of children.\n" }

It is important that this product be disposed of properly. See patient instructions for disposal information.

{ "type": "p", "children": [], "text": "\nIt is important that this product be disposed of properly. See patient instructions for disposal information.\n" }

Dosage and Administration: See package insert.

{ "type": "p", "children": [], "text": "\nDosage and Administration: See package insert." }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Rrule"> <p class="First">Date of Patch Application</p> <p>MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied</td><td align="center" class="Botrule Lrule Rrule">Time Removed</td><td align="center" class="Botrule Lrule Rrule">Application Side</td><td align="center" class="Botrule Lrule Rrule">Disposal Method</td><td align="center" class="Botrule Lrule Rrule">Date of Patch Application<p class="First">MM/DD/YYYY</p> </td><td align="center" class="Botrule Lrule Rrule">Time Applied </td><td align="center" class="Botrule Lrule Rrule">Time Removed </td><td align="center" class="Botrule Lrule Rrule">Application Side </td><td align="center" class="Botrule Lrule">Disposal Method </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> <tr class="Last"> <td class="Botrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Rrule Toprule"> <p class="First">_Fold &amp; flush</p> <p>_ Fold &amp; trash</p> </td><td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _AM _PM</td><td align="center" class="Botrule Lrule Rrule Toprule"> _Right _Left</td><td align="right" class="Botrule Lrule Toprule">_Fold &amp; flush<p class="First">_ Fold &amp; trash</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Rrule\">\n<p class=\"First\">Date of Patch Application</p>\n<p>MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Disposal Method</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Date of Patch Application<p class=\"First\">MM/DD/YYYY</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Applied </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Time Removed </td><td align=\"center\" class=\"Botrule Lrule Rrule\">Application Side </td><td align=\"center\" class=\"Botrule Lrule\">Disposal Method </td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">_Fold &amp; flush</p>\n<p>_ Fold &amp; trash</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _AM _PM</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> _Right _Left</td><td align=\"right\" class=\"Botrule Lrule Toprule\">_Fold &amp; flush<p class=\"First\">_ Fold &amp; trash</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }