Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in:

{ "type": "p", "children": [], "text": "Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in:\n" }

anesthesia (all ages)

{ "type": "p", "children": [], "text": "\nanesthesia (all ages)\n" }

{ "type": "ul", "children": [ "for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,\n", "intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and\n", "for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.\n" ], "text": "" }

peptic ulcer (adults)

{ "type": "p", "children": [], "text": "\npeptic ulcer (adults)\n" }

{ "type": "ul", "children": [ "as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.\n" ], "text": "" }

Preanesthetic Medication

The recommended dose of Glycopyrrolate Injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.

Intraoperative Medication

Glycopyrrolate Injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes. Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance.

Reversal of Neuromuscular Blockade

The recommended dose of Glycopyrrolate Injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine.

Peptic Ulcer

The usual recommended dose of Glycopyrrolate Injection is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose. Frequency of administration should be dictated by patient response up to a maximum of four times daily.

Preanesthetic Medication

The recommended dose of Glycopyrrolate Injection in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. Patients under 2 years of age may require up to 0.009 mg/kg.

Do not use this prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

Intraoperative Medication

Because of the long duration of action of Glycopyrrolate Injection if used as preanesthetic medication, additional Glycopyrrolate Injection for anticholinergic effect intraoperatively is rarely needed; in the event it is required the recommended pediatric dose is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose which may be repeated, as needed, at intervals of 2 to 3 minutes. Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance.

Do not use this prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

Reversal of Neuromuscular Blockade

The recommended pediatric dose of Glycopyrrolate Injection is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Do not use this prefilled syringe to administer a dose of less than 0.1 mg (0.5 mL).

Peptic Ulcer

Glycopyrrolate Injection is not indicated for the treatment of peptic ulcer in pediatric patients.

Diluent Compatibilities

Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer's Injection.

Diluent Incompatibilities

Lactated Ringer's solution.

Admixture Compatibilities

Physical Compatibility

This list does not constitute an endorsement of the clinical utility or safety of co-administration of Glycopyrrolate Injection with these drugs. Glycopyrrolate Injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; physostigmine salicylate; diphenhydramine HCl; codeine phosphate, USP; benz-quinamide HCl; hydromorphone HCl, USP; droperidol; levorphanol tartrate; lidocaine, USP; meperidine HCl, USP; pyridostigmine bromide; morphine sulfate, USP; nalbuphine HCl; oxymorphone HCl; procaine HCl, USP; promethazine HCl, USP; neostigmine methylsulfate, USP; scopolamine HBr, USP; butorphanol tartrate; fentanyl citrate; trimethobenzamide HCl; and hydroxyzine HCl. Glycopyrrolate Injection may be administered via the tubing of a running infusion of normal saline.

Admixture Incompatibilities

Physical Incompatibility

Because the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine Glycopyrrolate Injection in the same syringe with methohexital Na; chloramphenicol Na succinate; dimenhydrinate; pentobarbital Na; thiopental Na; secobarbital Na; sodium bicarbonate; diazepam; dexamethasone Na phosphate; or pentazocine lactate. These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.

Figure 1: Outer Packaging and Prefilled Syringe

Glycopyrrolate Injection, USP, is a clear, colorless solution available in 0.6 mg/3 mL (0.2 mg/mL) single-dose, prefilled, disposable syringes.

{ "type": "p", "children": [], "text": "Glycopyrrolate Injection, USP, is a clear, colorless solution available in 0.6 mg/3 mL (0.2 mg/mL) single-dose, prefilled, disposable syringes.\n" }

Glycopyrrolate Injection is contraindicated in:

{ "type": "p", "children": [], "text": "Glycopyrrolate Injection is contraindicated in:\n" }

{ "type": "ul", "children": [ "patients with known hypersensitivity to Glycopyrrolate Injection or any of its inactive ingredients.\n", "peptic ulcer patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.\n" ], "text": "" }

Glycopyrrolate Injection may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).

Glycopyrrolate Injection may cause drowsiness or blurred vision. Warn patients not to participate in activities requiring mental alertness, such as operating a motor vehicle or other machinery, or performing hazardous work, until these issues resolve.

In the presence of fever, high environmental temperature, and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including Glycopyrrolate Injection (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving Glycopyrrolate Injection.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Glycopyrrolate Injection is inappropriate and possibly harmful. Avoid use in patients with these conditions.

Investigate any tachycardia before giving Glycopyrrolate Injection because an increase in the heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, and/or hyperthyroidism.

Renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary in this population [see Pharmacokinetics (12.3)]

Use Glycopyrrolate Injection with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia, because anticholinergic drugs may aggravate these conditions. Consider dose reduction and closely monitor the elderly and patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostatic hypertrophy, or hiatal hernia.

The use of anticholinergetic drugs, including Glycopyrrolate Injection, in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis. Monitor patients for symptoms such as vomiting, dyspepsia, early satiety, abdominal distention, and increased abdominal pain. Discontinue Glycopyrrolate Injection treatment if these symptoms develop or worsen on treatment.

Patients may experience sensitivity of the eyes to light. Advise patients to protect their eyes from light after receiving Glycopyrrolate Injection.

The following adverse reactions were identified in clinical studies or postmarketing reports. 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 were identified in clinical studies or postmarketing reports. 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.\n" }

Adverse reactions to anticholinergics include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.

{ "type": "p", "children": [], "text": "Adverse reactions to anticholinergics include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.\n" }

The following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.

{ "type": "p", "children": [], "text": "The following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.\n" }

The concurrent use of Glycopyrrolate Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and result in an increase in anticholinergic side effects.

{ "type": "p", "children": [], "text": "The concurrent use of Glycopyrrolate Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and result in an increase in anticholinergic side effects.\n" }

Concomitant administration of Glycopyrrolate Injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.

{ "type": "p", "children": [], "text": "Concomitant administration of Glycopyrrolate Injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.\n" }

Risk summary

Limited data are available with glycopyrrolate use during pregnancy have not identified a drug-associated risk of birth defects and miscarriage, however, most of the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of Cesarean-section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores (see Data).

In animal reproduction studies in pregnant rats and rabbits administered glycopyrrolate orally (rats) and intramuscularly (rabbits) during the period of organogenesis, no teratogenic effects were seen at 320-times and 5 times the maximum recommended human dose (MRHD) of 2 mg (on a mg/m2 basis), respectively (see Data).

The estimated background risk for 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 the clinically recognized pregnancies is 2-4% and 15−20%, respectively.

Data

Human Data

Published, randomized, controlled trials over several decades, which compared the use of glycopyrrolate to another antimuscarinic agent in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. In normal doses (0.004 mg/kg), glycopyrrolate does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and arterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts.

There are no studies on the safety of glycopyrrolate exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to glycopyrrolate during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to glycopyrrolate.

Animal Data

Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m2 basis). These studies produced no teratogenic effects to the fetus.

A preclinical study on reproductive performance of rats given glycopyrrolate resulted in a decreased rate of conception and survival at weaning.

Risk summary

There are no data on the presence of glycopyrrolate in either human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergics, glycopyrrolate may cause suppression of lactation [see Adverse Reactions (6)]. The developmental and health benefits of breast feeding should be considered along with the mother's clinical need for Glycopyrrolate Injection and any potential adverse effects on the breastfed child from Glycopyrrolate Injection or from the underlying maternal condition.

Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.

Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients.

Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.

A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including Glycopyrrolate Injection. Infants and young children are especially susceptible to the toxic effects of anticholinergics.

Clinical Studies of Glycopyrrolate Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.

Renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary [see Clinical Pharmacology (12.3)].

To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.

{ "type": "p", "children": [], "text": "To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.\n" }

If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients.

{ "type": "p", "children": [], "text": "If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients.\n" }

To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.

{ "type": "p", "children": [], "text": "To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.\n" }

Fever should be treated symptomatically.

{ "type": "p", "children": [], "text": "Fever should be treated symptomatically.\n" }

Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

{ "type": "p", "children": [], "text": "Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.\n" }

Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL contains:

{ "type": "p", "children": [], "text": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL contains:\n" }

Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s., pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives.

{ "type": "p", "children": [], "text": "Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s., pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives.\n" }

Glycopyrrolate is a quaternary ammonium salt with the following chemical name:

{ "type": "p", "children": [], "text": "Glycopyrrolate is a quaternary ammonium salt with the following chemical name:\n" }

3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.

{ "type": "p", "children": [], "text": "3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.\n" }

Its structural formula is as follows:

{ "type": "p", "children": [], "text": "Its structural formula is as follows:\n" }

Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It completely ionized at physiological pH values. Glycopyrrolate Injection, USP, is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).

{ "type": "p", "children": [], "text": "Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It completely ionized at physiological pH values. Glycopyrrolate Injection, USP, is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).\n" }

Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily. For this reason, the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily. With intravenous injection, the onset of action is generally evident within one minute. Following intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine.

The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods.

Distribution

The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22 L/kg.

Elimination

Metabolism

The in vivo metabolism of glycopyrrolate in humans has not been studied.

Excretion

The mean clearance and mean t1/2 values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.27 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of the radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the mean t1/2 value is reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study.

<div class="scrollingtable"><table width="100%"> <col align="left" width="13.441%"/> <col align="left" width="13.241%"/> <col align="left" width="13.241%"/> <col align="left" width="14.255%"/> <col align="left" width="14.255%"/> <col align="left" width="13.241%"/> <col align="left" width="18.326%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="7" valign="top"> <p class="First Footnote">* 0 to 8 hr </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">Group </td><td align="center" class="Botrule Rrule Toprule" valign="top">t<span class="Sub">1/2</span> <br/>(hr) </td><td align="center" class="Botrule Rrule Toprule" valign="top">V<span class="Sub">ss</span> <br/>(L/kg) </td><td align="center" class="Botrule Rrule Toprule" valign="top">CL<br/>(L/kg/hr) </td><td align="center" class="Botrule Rrule Toprule" valign="top">T<span class="Sub">max</span> <br/>(min) </td><td align="center" class="Botrule Rrule Toprule" valign="top">C<span class="Sub">max</span> (mcg /L) </td><td align="center" class="Botrule Rrule Toprule" valign="top">AUC<br/>(mcg/L<span class="Sup">●</span>hr) </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top">(6 mcg/kg IV) </td><td align="center" class="Botrule Rrule" valign="top">0.83 ± 0.27 </td><td align="center" class="Botrule Rrule" valign="top">0.42 ± 0.22 </td><td align="center" class="Botrule Rrule" valign="top">0.54 ± 0.14 </td><td align="center" class="Botrule Rrule" valign="top">- </td><td align="center" class="Botrule Rrule" valign="top">- </td><td align="center" class="Botrule Rrule" valign="top">8.64 ± 1.49* </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top">(8 mcg/kg IM) </td><td align="center" class="Botrule Rrule" valign="top">- </td><td align="center" class="Botrule Rrule" valign="top">- </td><td align="center" class="Botrule Rrule" valign="top">- </td><td align="center" class="Botrule Rrule" valign="top">27.48 ± 6.12 </td><td align="center" class="Botrule Rrule" valign="top">3.47 ± 1.48 </td><td align="center" class="Botrule Rrule" valign="top">6.64 ± 2.33* </td> </tr> </tbody> </table></div>

Specific Populations

Pediatric Patients

Following IV administration (5 mcg/kg glycopyrrolate) to infants and children, the mean t1/2 values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

Patients with Renal Impairment

In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hr- mcg /L), mean plasma clearance (0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly different than those of controls (3.73 hr-mcg/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure.

Carcinogenesis

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenesis

Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted.

Impairment of Fertility

In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.

Glycopyrrolate Injection, USP, 0.2 mg per mL without preservative is available as:

{ "type": "p", "children": [], "text": "Glycopyrrolate Injection, USP, 0.2 mg per mL without preservative is available as:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="17.425%"/> <col align="left" width="25.250%"/> <col align="left" width="25.300%"/> <col align="left" width="32.025%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Product</span> <br/> <span class="Bold">Code</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Unit of Sale</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Strength</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Each</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">720330 </td><td align="left" class="Botrule Rrule" valign="top">NDC 76045-023-30<br/>Unit of 10 </td><td align="left" class="Botrule Rrule" valign="top">0.6 mg/3 mL<br/>(0.2 mg/mL) </td><td align="left" class="Botrule Rrule" valign="top">NDC 76045-023-00<br/>3 mL single-dose pre-filled disposable syringe </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">RF720330 </td><td align="left" class="Botrule Rrule" valign="top">NDC 76045-223-30<br/>Unit of 10 </td><td align="left" class="Botrule Rrule" valign="top">0.6 mg/3 mL<br/>(0.2 mg/mL) </td><td align="left" class="Botrule Rrule" valign="top">NDC 76045-223-03<br/>3 mL single-dose pre-filled disposable syringe<br/>This product contains an RFID. </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"17.425%\"/>\n<col align=\"left\" width=\"25.250%\"/>\n<col align=\"left\" width=\"25.300%\"/>\n<col align=\"left\" width=\"32.025%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Product</span>\n<br/>\n<span class=\"Bold\">Code</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Unit of Sale</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Strength</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\">Each</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">720330\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">NDC 76045-023-30<br/>Unit of 10\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">0.6 mg/3 mL<br/>(0.2 mg/mL)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">NDC 76045-023-00<br/>3 mL single-dose pre-filled disposable syringe\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">RF720330\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">NDC 76045-223-30<br/>Unit of 10\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">0.6 mg/3 mL<br/>(0.2 mg/mL)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">NDC 76045-223-03<br/>3 mL single-dose pre-filled disposable syringe<br/>This product contains an RFID.\n</td>\n</tr>\n</tbody>\n</table></div>" }

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.]\n" }

Sensitive to heat – Do not autoclave. Discard unused portion.

{ "type": "p", "children": [], "text": "Sensitive to heat – Do not autoclave. Discard unused portion.\n" }

Do not place syringe on a sterile field.

{ "type": "p", "children": [], "text": "Do not place syringe on a sterile field.\n" }

Drowsiness or Blurred Vision: Inform patients that Glycopyrrolate Injection may cause drowsiness or blurred vision. Warn patients not to operate a motor vehicle or other machinery or perform hazardous work until these issues resolve. [see Warnings and Precautions (5.2)].

Heat Prostration: Inform patients that in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents, including Glycopyrrolate Injection (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving Glycopyrrolate Injection [see Warnings and Precautions (5.3)].

Light Sensitivity: Advise patients that Glycopyrrolate Injection may cause sensitivity of the eyes to light and to protect their eyes from light after receiving Glycopyrrolate Injection [see Warnings and Precautions (5.9)].

Drug Interactions: Inform patients that Glycopyrrolate Injection may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions (7)].

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

U.S. Patent 9,731,082

www.fresenius-kabi.com/us

451718D

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label\n" }

3 mL Single-Dose Prefilled Syringe. For IM or IV Use. Rx only

{ "type": "p", "children": [], "text": "3 mL Single-Dose Prefilled Syringe. For IM or IV Use. Rx only\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label\n" }

RF720330         NDC 76045-223-03

{ "type": "p", "children": [], "text": "RF720330         NDC 76045-223-03\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

For Intramuscular or Intravenous Use.          Rx only

{ "type": "p", "children": [], "text": "\nFor Intramuscular or Intravenous Use.          Rx only\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label\n" }

Rx only         NDC 76045-223-30

{ "type": "p", "children": [], "text": "Rx only         NDC 76045-223-30\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

For Intramuscular or Intravenous Use.

{ "type": "p", "children": [], "text": "\nFor Intramuscular or Intravenous Use.\n" }

Do NOT place syringe on a Sterile Field.

{ "type": "p", "children": [], "text": "Do NOT place syringe on a Sterile Field.\n" }

10 x 3 ml Single-Dose Prefilled Syringes

{ "type": "p", "children": [], "text": "\n10 x 3 ml Single-Dose Prefilled Syringes\n" }

Discard unused portion.

{ "type": "p", "children": [], "text": "\nDiscard unused portion.\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Syringe Label\n" }

3 ml Single-Dose Prefilled Syringe. For IM or IV Use. Rx only

{ "type": "p", "children": [], "text": "3 ml Single-Dose Prefilled Syringe. For IM or IV Use. Rx only\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Blister Label\n" }

Rx only          NDC 76045-023-00

{ "type": "p", "children": [], "text": "Rx only          NDC 76045-023-00\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

For Intramuscular or Intravenous Use.

{ "type": "p", "children": [], "text": "\nFor Intramuscular or Intravenous Use.\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY – Glycopyrrolate Injection, USP 3 mL Carton Label\n" }

Rx only         NDC 76045-023-30

{ "type": "p", "children": [], "text": "Rx only         NDC 76045-023-30\n" }

Glycopyrrolate Injection, USP

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Injection, USP\n" }

0.6 mg / 3 mL (0.2 mg /mL)

{ "type": "p", "children": [], "text": "\n0.6 mg / 3 mL (0.2 mg /mL)\n" }

For Intramuscular or Intravenous Use.

{ "type": "p", "children": [], "text": "\nFor Intramuscular or Intravenous Use.\n" }

Do NOT place syringe on a Sterile Field.

{ "type": "p", "children": [], "text": "Do NOT place syringe on a Sterile Field.\n" }

10 x 3 ml Single-Dose Prefilled Syringes

{ "type": "p", "children": [], "text": "\n10 x 3 ml Single-Dose Prefilled Syringes\n" }

Discard unused portion.

{ "type": "p", "children": [], "text": "\nDiscard unused portion.\n" }

 Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

{ "type": "p", "children": [], "text": " Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy)." }

Glycopyrrolate oral solution must be measured and administered with an accurate measuring device[seePatient Counseling Information (17)].

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution must be measured and administered with an accurate measuring device[seePatient Counseling Information (17)].\n" }

Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. For greater detail, see Table 1.

{ "type": "p", "children": [], "text": " Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. For greater detail, see Table 1." }

During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver.

{ "type": "p", "children": [], "text": " During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver." }

Glycopyrrolate oral solution  should be dosed at least one hour before or two hours after meals.

{ "type": "p", "children": [], "text": " Glycopyrrolate oral solution  should be dosed at least one hour before or two hours after meals." }

The presence of high fat food reduces the oral bioavailability of glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3)].

{ "type": "p", "children": [], "text": " The presence of high fat food reduces the oral bioavailability of glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3)].\n" }

Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily)

{ "type": "p", "children": [], "text": "\nTable 1: Recommended Dose Titration Schedule (each dose to be given three times daily)\n" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="8.44%"/> <col width="8.3%"/> <col width="8.34%"/> <col width="8.24%"/> <col width="8.36%"/> <col width="7.78%"/> <col width="8.24%"/> <col width="8.74%"/> <col width="8.24%"/> <col width="8.36%"/> <col width="8.24%"/> <col width="8.74%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Weight</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Dose Level 1</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Dose Level 2</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Dose Level 3</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Dose Level 4</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">Dose Level 5</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> <span class="Bold">kg</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> <span class="Bold">lbs</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">(~0.02</span><span class="Bold"> </span><span class="Bold">mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">(~0.04</span><span class="Bold"> </span><span class="Bold">mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">(~0.06</span><span class="Bold"> </span><span class="Bold">mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">(~0.08</span><span class="Bold"> </span><span class="Bold">mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="top">  <br/> <span class="Bold">(~0.1 mg/kg)</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 13-17<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 27-38<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.3 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.6 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.9 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 4.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.2 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 6 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.5 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 7.5 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 18-22<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 39-49<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.4 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.8 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 4 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.2 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 6 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.6 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 8 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 10 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 23-27<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 50-60<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.5 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.5 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 7.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 10 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.5 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 12.5 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 28-32<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 61-71<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.6 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.2 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 6 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.8 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 9 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.4 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 12 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 33-37<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 72-82<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.7 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.4 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 7 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.1 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 10.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.8 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 14 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 38-42<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 83-93<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.8 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 4 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.6 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 8 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.4 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 12 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top">  <br/> 43-47<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 94-104<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.9 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 4.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.8 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 9 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.7 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 13.5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="top">  <br/> ≥48<br/> </td><td align="center" class="Rrule" valign="top">  <br/> ≥105<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 5 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 10 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 mg<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 15 mL<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\">\n<colgroup>\n<col width=\"8.44%\"/>\n<col width=\"8.3%\"/>\n<col width=\"8.34%\"/>\n<col width=\"8.24%\"/>\n<col width=\"8.36%\"/>\n<col width=\"7.78%\"/>\n<col width=\"8.24%\"/>\n<col width=\"8.74%\"/>\n<col width=\"8.24%\"/>\n<col width=\"8.36%\"/>\n<col width=\"8.24%\"/>\n<col width=\"8.74%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Weight</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Dose Level 1</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Dose Level 2</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Dose Level 3</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Dose Level 4</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">Dose Level 5</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> <span class=\"Bold\">kg</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> <span class=\"Bold\">lbs</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">(~0.02</span><span class=\"Bold\"> </span><span class=\"Bold\">mg/kg)</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">(~0.04</span><span class=\"Bold\"> </span><span class=\"Bold\">mg/kg)</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">(~0.06</span><span class=\"Bold\"> </span><span class=\"Bold\">mg/kg)</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">(~0.08</span><span class=\"Bold\"> </span><span class=\"Bold\">mg/kg)</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">  <br/> <span class=\"Bold\">(~0.1 mg/kg)</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 13-17<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 27-38<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.3 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.6 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.9 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 4.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.2 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 6 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.5 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 7.5 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 18-22<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 39-49<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.4 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.8 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 4 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.2 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 6 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.6 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 8 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 10 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 23-27<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 50-60<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.5 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.5 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 7.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 10 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.5 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 12.5 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 28-32<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 61-71<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.6 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.2 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 6 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.8 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 9 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.4 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 12 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 33-37<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 72-82<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.7 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.4 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 7 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.1 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 10.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.8 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 14 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 38-42<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 83-93<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.8 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 4 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.6 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 8 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.4 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 12 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> 43-47<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 94-104<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 0.9 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 4.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.8 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 9 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.7 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 13.5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">  <br/> ≥48<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> ≥105<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 1.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 5 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 2.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 10 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 3.0 mg<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\">  <br/> 15 mL<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

Glycopyrrolate oral solution is available as a 1 mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles.

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution is available as a 1 mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles." }

Glycopyrrolate is contraindicated in:

{ "type": "p", "children": [], "text": "Glycopyrrolate is contraindicated in:" }

{ "type": "ul", "children": [ "Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis).", "Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of glycopyrrolate." ], "text": "" }

Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see Adverse Reactions (6.1) ].Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.

Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with glycopyrrolate and evaluate for intestinal obstruction.

In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as glycopyrrolate. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.

Glycopyyrolate may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking glycopyrrolate.

Use glycopyrrolate with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:

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 data described below reflect exposure to glycopyrrolate in 151 subjects, including 20 subjects who participated in an 8-week placebo-controlled study (Study 1) and 137 subjects who participated in a 24-week open-label study (six subjects who received glycopyrrolate in the placebo-controlled study and 131 new subjects).

Table 2 presents adverse reactions reported by ≥ 15% of glycopyrrolate-treated subjects from the placebo-controlled clinical trial.

Table 2: Adverse Reactions Occurring in ≥ 15% of Glycopyrrolate -Treated Subjects                and at a Greater Frequency than Placebo in Study 1

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="45.48%"/> <col width="26.92%"/> <col width="27.6%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="justify" class="Lrule Rrule" valign="top">  <br/> </td><td align="center" class="Rrule" valign="top"> <span class="Bold">Glycopyrrolate</span><span class="Bold"> </span><span class="Bold">(N=20)</span> <br/> <span class="Bold">n (%)</span> <br/> </td><td align="center" class="Rrule" valign="top"> <span class="Bold">Placebo (N=18)</span> <br/> <br/> <span class="Bold">n (%)</span> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Dry Mouth<br/> </td><td align="center" class="Rrule" valign="top"> 8 (40%)<br/> </td><td align="center" class="Rrule" valign="top"> 2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Vomiting<br/> </td><td align="center" class="Rrule" valign="top"> 8 (40%)<br/> </td><td align="center" class="Rrule" valign="top"> 2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Constipation<br/> </td><td align="center" class="Rrule" valign="top"> 7 (35%)<br/> </td><td align="center" class="Rrule" valign="top"> 4 (22%)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Flushing<br/> </td><td align="center" class="Rrule" valign="top"> 6 (30%)<br/> </td><td align="center" class="Rrule" valign="top"> 3 (17%)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Nasal Congestion<br/> </td><td align="center" class="Rrule" valign="top"> 6 (30%)<br/> </td><td align="center" class="Rrule" valign="top"> 2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Headache<br/> </td><td align="center" class="Rrule" valign="top"> 3 (15%)<br/> </td><td align="center" class="Rrule" valign="top"> <br/> 1 (6%) </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Sinusitis<br/> </td><td align="center" class="Rrule" valign="top"> 3 (15%)<br/> <br/> </td><td align="right" class="Rrule" valign="top"> <br/> <br/> 1 (6%) </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> Upper Respiratory Tract Infection<br/> </td><td align="center" class="Rrule" valign="top"> 3 (15%)<br/> </td><td align="center" class="Rrule" valign="top"> <br/> 0 </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="top"> Urinary Retention<br/> </td><td align="center" class="Rrule" valign="top"> 3 (15%)<br/> <br/> </td><td align="center" class="Rrule" valign="top"> <br/> <br/> 0 </td> </tr> </tbody> </table></div>

The following adverse reactions occurred at a rate of <2% of patients receiving glycopyrrolate in the open-label study. Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue General Disorders: Irritability, pain Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection Investigations: Heart rate increase Metabolism and Nutrition: Dehydration Nervous System: Headache, convulsion, dysgeusia, nystagmus Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness Skin: Dry skin, pruritus, rash Vascular: Pallor

The following adverse reactions have been identified during postapproval use of other formulations of glycopyrrolate for other indications. Because these reactions are 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.

Additional adverse reactions identified during postapproval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.

Drugs Affected by Reduced GI Transit Time Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.

{ "type": "p", "children": [], "text": "\nDrugs Affected by Reduced GI Transit Time\n Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms." }

{ "type": "ul", "children": [ "The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are contraindicated[see  Contraindications(4)].\n", "Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is coadministered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules)." ], "text": "" }

Amantadine The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine.

{ "type": "p", "children": [], "text": "\nAmantadine\n The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine." }

Drugs Whose Plasma Levels May be Increased by Glycopyrrolate Coadministration of glycopyrrolate may result in increased levels of certain drugs.

{ "type": "p", "children": [], "text": "\nDrugs Whose Plasma Levels May be Increased by Glycopyrrolate \n Coadministration of glycopyrrolate may result in increased levels of certain drugs." }

{ "type": "ul", "children": [ "Atenolol’s bioavailability may be increased with coadministration of glycopyrrolate. A reduction in the atenolol dose may be needed.", "Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin’s pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted." ], "text": "" }

Drugs Whose Plasma Levels May be Decreased by Glycopyrrolate Coadministration of glycopyrrolate may result in decreased levels of certain drugs.

{ "type": "p", "children": [], "text": "\nDrugs Whose Plasma Levels May be Decreased by Glycopyrrolate\n Coadministration of glycopyrrolate may result in decreased levels of certain drugs." }

{ "type": "ul", "children": [ "Haloperidol’s serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia. Closely monitor patients if coadministration cannot be avoided.", "Levodopa’s therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa." ], "text": "" }

Risk Summary There are no available data in pregnant women for glycopyrrolate to inform decisions concerning any drug-associated risks. In pregnant rats, daily oral administration of glycopyrrolate during organogenesis at dose exposures 2.5 to 113 times the exposure at the maximum recommended human dose (MRHD) did not result in an increased incidence of gross external or visceral defects [see Data]. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis at dose exposures equivalent to up to approximately 7.8 times the exposure at the MRHD, no adverse effects on embryo-fetal development were seen. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Animal Data Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups. There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity.

Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1.0 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 0.8, 4.6, and 7.8 times, respectively, the estimated systemic exposure in humans at the MRHD. Glycopyrrolate did not affect maternal survival under the conditions of this study. Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1.0 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects.

Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter. No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups.

Risk Summary There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glycopyrrolate and any potential adverse effects on the breastfed infant from glycopyrrolate or from the underlying maternal condition.

Glycopyrrolate was evaluated for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling. Glycopyrrolate has not been studied in subjects under the age of 3 years.

Clinical studies of glycopyrrolate did not include subjects aged 65 and over.

Because glycopyrrolate is largely renally eliminated, glycopyrrolate should be used with caution in patients with renal impairment [see Clinical Pharmacology (12.3)].

Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:

{ "type": "p", "children": [], "text": "Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:" }

{ "type": "ul", "children": [ "Maintain an open airway, providing ventilation as necessary.", "Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage.", "Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus.", "Administering activated charcoal orally as appropriate." ], "text": "" }

Glycopyrrolate USP is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(SR)-(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-, [RS-] bromide. The chemical structure is:

{ "type": "p", "children": [], "text": "Glycopyrrolate USP is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(SR)-(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-, [RS-] bromide. The chemical structure is:" }

The molecular formula for glycopyrrolate oral solution is C19H28BrNO3 and the molecular weight is 398.3. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, cherry flavour (Art & Nat), methylparaben, propylene glycol, propylparaben, sodium citrate dihydrate, saccharin sodium, sorbitol solution, and purified water.

{ "type": "p", "children": [], "text": " The molecular formula for glycopyrrolate oral solution is C19H28BrNO3 and the molecular weight is 398.3. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, cherry flavour (Art & Nat), methylparaben, propylene glycol, propylparaben, sodium citrate dihydrate, saccharin sodium, sorbitol solution, and purified water." }

Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

Absorption In a parallel study of children (n=6 per group) aged 7-14 years undergoing intraocular surgery, subjects received either intravenous (IV) or oral glycopyrrolate as a premedication. The mean absolute bioavailability of oral glycopyrrolate tablets was low (approximately 3%) and highly variable among subjects (range 1.3 to 13.3%). A similar pattern of low and variable relative bioavailability is seen in adults.

Analysis of population pharmacokinetic data from normal adults and children with cerebral palsy associated chronic moderate to severe drooling failed to demonstrate linear pharmacokinetics across the dose range. In the same analysis, population estimates of the apparent oral clearance (scaled by weight in children and adults) ranged from 5.28 - 38.95 L/hr/kg for healthy adults and 8.07 - 25.65 L/hr/kg for patients with cerebral palsy, a reflection of the low and highly variable oral bioavailability of glycopyrrolate.

Absorption of glycopyrrolate (fasting) was compared to that of a marketed glycopyrrolate oral tablet. The Cmax after oral solution administration was 23% lower compared to tablet administration and AUC0-inf was 28% lower after oral solution administration. Mean Cmax after oral solution administration in the fasting state was 0.318 ng/mL, and mean AUC0-24 was 1.74 ng•hr/mL. Mean time to maximum plasma concentration for glycopyrrolate was 3.1 hours, and mean plasma half-life was 3.0 hours.

In healthy adults, a high fat meal was shown to significantly affect the absorption of glycopyrrolate oral solution (10 mL, 1 mg/5 mL). The mean Cmax under fed high fat meal conditions was approximately 74% lower than the Cmax observed under fasting conditions. Similarly, mean AUC0-T was reduced by about 78% by the high fat meal compared with the fasting AUC0-T. A high fat meal markedly reduces the oral bioavailability of glycopyrrolate. Therefore, glycopyrrolate should be dosed at least one hour before or two hours after meals. Pharmacokinetic results (mean ± SD) are described in Table 3.

Table 3: Pharmacokinetic Parameters (mean±SD) for Glycopyrrolate, Fasting and Fed, in Healthy Adults

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="16.66%"/> <col width="16.66%"/> <col width="16.66%"/> <col width="16.66%"/> <col width="16.66%"/> <col width="16.68%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="top">  <br/> </td><td class="Rrule" valign="top">  <br/> <span class="Bold">C</span><span class="Bold"><span class="Sub">max</span></span><span class="Bold"> </span><span class="Bold">(ng/mL)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> <span class="Bold">T</span><span class="Bold"><span class="Sub">max </span></span><span class="Bold">(hrs)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> <span class="Bold">AUC</span><span class="Bold"><span class="Sub">0-T</span></span> <br/> <span class="Bold">(ng·hr/mL)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> <span class="Bold">AUC</span><span class="Bold"><span class="Sub">0-Inf</span></span> <br/> <span class="Bold">(ng·hr/mL)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> <span class="Bold">T</span><span class="Bold"><span class="Sub">1/2</span></span> <br/> <span class="Bold">(hrs)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">  <br/> <span class="Bold">Fasting (n=37)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.318 ± 0.190<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.10 ± 1.08<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.74 ± 1.07<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 1.81 ± 1.09<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.0 ± 1.2<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top">  <br/> <span class="Bold">Fed (n=36)</span> <br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.084 ± 0.081<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 2.60 ± 1.12<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.38 ± 0.14<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 0.46 ± 0.13*<br/> </td><td align="center" class="Rrule" valign="top">  <br/> 3.2 ± 1.1*<br/> </td> </tr> </tbody> </table></div>

*n=35

Distribution After IV administration, glycopyrrolate has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg +/- 0.22).

Metabolism In adult patients who underwent surgery for cholelithiasis and were given a single IV dose of tritiated glycopyrrolate, approximately 85% of total radioactivity was excreted in urine and <5% was present in T-tube drainage of bile. In both urine and bile, >80% of the radioactivity corresponded to unchanged drug. These data suggest a small proportion of IV glycopyrrolate is excreted as one or more metabolites.

Elimination Approximately 65-80% of an IV glycopyrrolate dose was eliminated unchanged in urine in adults. In two studies, after IV administration to pediatric patients ages 1-14 years, mean clearance values ranged from 1.01- 1.41 L/kg/hr (range 0.32 -2.22 L/kg/hr). In adults, IV clearance values were 0.54 ± 0.14 L/kg/hr.

Pediatrics The estimated apparent clearance of glycopyrrolate from a population pharmacokinetic analysis (scaled by weight in children and adults) of oral and IV data was found to be 13.2 L/hr/kg or 92.7 L/hr for a typical 70 kg subject. In the same population based analysis, gender was not identified as having an effect on either glycopyrrolate clearance or systemic exposure.

Gender Population pharmacokinetic evaluation of adults and children administered IV or oral glycopyrrolate identified no effect of gender on glycopyrrolate clearance or systemic exposure.

Race The pharmacokinetics of glycopyrrolate by race has not been characterized.

Elderly Glycopyrrolate pharmacokinetics have not been characterized in the elderly.

Renal Impairment In one study, glycopyrrolate 4 mcg/kg was administered intravenously in uremic patients undergoing renal transplantation surgery. Mean AUC (10.6 mcg•h/L), mean plasma clearance (0.43 L/hr/kg) and mean 3-hour urinary excretion (0.7%) for glycopyrrolate were significantly different than those of control patients (3.73 µg•h/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that elimination of glycopyrrolate is severely impaired in patients with renal failure.

Hepatic Impairment Glycopyrrolate is largely renally eliminated. The pharmacokinetics of glycopyrrolate have not been evaluated in patients with hepatic impairment.

When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, resulting in systemic exposures (estimated AUC0-inf values) approximately 0.1, 0.3, and 0.8 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses), no significant changes in tumor incidence were observed when compared to control.

When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, resulting in systemic exposures approximately 0.2, 0.8, and 2 times, respectively, the estimated systemic exposure in humans at the MRHD, no significant changes in tumor incidence were observed when compared to control.

Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay.

Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage, resulting in systemic exposures (estimated AUC0-inf values) in males and females up to approximately 11 and 15 times, respectively, the estimated systemic exposure in humans at the MRHD. No treatment-related effects on fertility or reproductive parameters were observed in either gender in this study.

Glycopyrrolate was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3-23 years; thirty-six subjects were aged 3-16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). Subjects were randomized in a 1:1 fashion to receive glycopyrrolate or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5-7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day.

{ "type": "p", "children": [], "text": "Glycopyrrolate was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3-23 years; thirty-six subjects were aged 3-16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). Subjects were randomized in a 1:1 fashion to receive glycopyrrolate or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5-7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day." }

Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS), which is presented below. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy.

{ "type": "p", "children": [], "text": " Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS), which is presented below. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy." }

Modified Teacher’s Drooling Scale 1= Dry: never drools 2= Mild: only the lips are wet; occasionally 3= Mild: only the lips are wet; frequently 4= Moderate: wet on the lips and chin; occasionally 5= Moderate: wet on the lips and chin; frequently 6= Severe: drools to the extent that clothing becomes damp; occasionally 7= Severe: drools to the extent that clothing becomes damp; frequently 8= Profuse: clothing, hands, tray, and objects become wet; occasionally 9= Profuse: clothing, hands, tray, and objects become wet; frequently Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8.

{ "type": "p", "children": [], "text": "\nModified Teacher’s Drooling Scale \n 1= Dry: never drools 2= Mild: only the lips are wet; occasionally 3= Mild: only the lips are wet; frequently 4= Moderate: wet on the lips and chin; occasionally 5= Moderate: wet on the lips and chin; frequently 6= Severe: drools to the extent that clothing becomes damp; occasionally 7= Severe: drools to the extent that clothing becomes damp; frequently 8= Profuse: clothing, hands, tray, and objects become wet; occasionally 9= Profuse: clothing, hands, tray, and objects become wet; frequently Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8." }

Table 4: Percentage of Responders at Week 8

{ "type": "p", "children": [], "text": "\nTable 4: Percentage of Responders at Week 8\n" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="50.64%"/> <col width="49.36%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="top"> <span class="Bold">Glycopyrrolate</span><span class="Bold"> Group</span> <br/> </td><td align="center" class="Rrule" valign="top"> <span class="Bold">Placebo Group</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="top"> <span class="Bold">(N=20)</span> <br/> </td><td align="center" class="Rrule" valign="top"> <span class="Bold">(N=18)</span> <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="top"> 15/20 (75%)<br/> </td><td align="center" class="Rrule" valign="top"> 2/18 (11%)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\">\n<colgroup>\n<col width=\"50.64%\"/>\n<col width=\"49.36%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">Glycopyrrolate</span><span class=\"Bold\"> Group</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Bold\">Placebo Group</span>\n<br/> </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> <span class=\"Bold\">(N=20)</span>\n<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> <span class=\"Bold\">(N=18)</span>\n<br/> </td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"top\"> 15/20 (75%)<br/> </td><td align=\"center\" class=\"Rrule\" valign=\"top\"> 2/18 (11%)<br/> </td>\n</tr>\n</tbody>\n</table></div>" }

Figure 1. Mean (± 2 Standard Errors) mDTS Scores

{ "type": "p", "children": [], "text": "\nFigure 1. Mean (± 2 Standard Errors) mDTS Scores\n" }

NDC 72205-070-72; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle.

{ "type": "p", "children": [], "text": "NDC 72205-070-72; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle." }

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

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

See FDA-approved patient labeling (Patient Information)

{ "type": "p", "children": [], "text": "See FDA-approved patient labeling (Patient Information)" }

{ "type": "ul", "children": [ "Advise patients/caregivers to measure glycopyrrolate with an accurate measuring device. A household teaspoon is not an accurate measuring device. Patients/caregivers should use a dosing cup available in pharmacies to accurately measure the correct milliliter dose. An oral syringe, also available in pharmacies, should be used to dispense glycopyrrolate into the child’s mouth from the cup. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.", "Administering glycopyrrolate with a high fat meal substantially reduces the amount of glycopyrrolate absorbed. Administer glycopyrrolate at least one hour before or two hours after meals.", "Glycopyrrolate is started at a low dose and gradually titrated over a period of weeks based on therapeutic response and adverse reactions. Patients/caregivers should not increase the dose without the physician’s permission.", "Common adverse reactions from glycopyrrolate include overly dry mouth, constipation, vomiting, flushing of the skin or face, and urinary retention. Side effects can sometimes be difficult to detect in some patients with neurologic problems who cannot adequately communicate how they feel. If side effects become troublesome after increasing a dose, decrease the dose to the prior one and contact your physician.", "Constipation is the most common side effect of glycopyrrolate, and if constipation occurs, stop administering glycopyrrolate to the patient and call their healthcare practitioner.", "Inability of the patient to urinate, dry diapers or undergarments, irritability or crying may be signs of urinary retention, and if urinary retention occurs, patients/caregivers should stop administering glycopyrrolate and call their healthcare practitioner.", "If the patient develops a skin rash, hives or an allergic reaction, parents/caregivers should stop administering glycopyrrolate and call their healthcare practitioner as this could be a sign of hypersensitivity to this product.", "Drugs like glycopyrrolate can reduce sweating, and if the patient is in a hot environment and flushing of the skin occurs this may be due to overheating. Avoid exposure of the patient to hot or very warm environmental temperatures to avoid overheating and the possibility of heat exhaustion or heat stroke." ], "text": "" }

The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse Novadoz Pharmaceuticals LLC.

{ "type": "p", "children": [], "text": "The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse Novadoz Pharmaceuticals LLC. " }

Manufactured by: MSN Pharmaceuticals Inc Piscataway, NJ 08854

{ "type": "p", "children": [], "text": "\nManufactured by: MSN Pharmaceuticals Inc\n Piscataway, NJ 08854" }

Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on: June 2022

{ "type": "p", "children": [], "text": "\nDistributed by:\n\nNovadoz Pharmaceuticals LLC\n Piscataway, NJ 08854-3714\nIssued on: June 2022" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0"> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> <span class="Bold">PATIENT and CAREGIVER INFORMATION<br/> Glycopyrrolate Oral Solution</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> Please read the Patient and Caregiver Information that comes with glycopyrrolate oral solution before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child’s medical condition or treatment.</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"> <span class="Bold">What is glycopyrrolate oral solution?</span> <br/> Glycopyrrolate oral solution is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling.</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">Who should not take glycopyrrolate oral solution?</span> <br/> Do not give glycopyrrolate oral solution to anyone who:<br/> <ul class="Disc"> <li>has problems urinating</li> <li>has a bowel problem called paralytic ileus</li> <li>lacks normal bowel tone or tension</li> <li>has severe ulcerative colitis or certain other serious bowel problems with severe ulcerative colitis</li> <li>has myasthenia gravis</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">What should I tell my doctor before giving glycopyrrolate oral solution to my child?</span> <br/> Tell your doctor if your child:<br/> <ul class="Disc"> <li>has any allergies</li> <li>has any stomach or bowel problems, including ulcerative colitis</li> <li>has any problems with constipation</li> <li>has thyroid problems</li> <li>has high blood pressure</li> <li>has heart problems or abnormal heart beats</li> <li>has a hiatal hernia with gastroesophageal reflux disease (GERD)</li> <li>has any eye problems</li> <li>has any problems urinating</li> <li>has any other medical conditions</li> <li>is pregnant or plans to become pregnant. It is not known if glycopyrrolate oral solution can harm an unborn baby.</li> <li>is breastfeeding or plans to breastfeed. It is not known if glycopyrrolate passes into breast milk and if it can harm the baby.</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">Tell your doctor about all of the medicines that your child takes,</span> including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way glycopyrrolate oral solution works, and glycopyrrolate oral solution may affect how some other medicines work.</td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">How should I give glycopyrrolate oral solution?</span> <br/> <ul class="Disc"> <li>Give glycopyrrolate oral solution exactly as prescribed by your child’s doctor.</li> <li>Give glycopyrrolate oral solution 1 hour before or 2 hours after meals.</li> <li>Your doctor will tell you how much (milliliters or mLs) of glycopyrrolate oral solution to give your child.</li> <li>Do not change the dose of glycopyrrolate oral solution unless your doctor tells you to.</li> <li>You must measure the dose of glycopyrrolate oral solution before giving it to your child. Use a special marked dose measuring cup (available at most pharmacies) to measure the right dose of glycopyrrolate oral solution.</li> <li>To help make sure that your child swallows the dose, you should use an oral syringe to give the child each dose of glycopyrrolate oral solution, after you measure the dose needed with a dose measuring cup. Oral syringes are also available at most pharmacies.</li> <li>If you have questions about how to measure the dose or how to use an oral syringe, ask your pharmacist or doctor.</li> <li>The dose of glycopyrrolate oral solution that is needed to control drooling may be different for each child. Glycopyrrolate oral solution is usually started at a low dose, and slowly increased as directed by your doctor. This slow increase in dose continues until the best dose for your child is reached, to control drooling.</li> <li>During this time it is important to stay in close contact with your child’s doctor, and tell the doctor about any side effects that your child has. See “What are the possible side effects of glycopyrrolate oral solution?”</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">What should I avoid while taking glycopyrrolate oral solution?</span> <br/> <ul class="Disc"> <li>Glycopyrrolate oral solution may cause sleepiness or blurred vision. Do not drive a car, operate heavy machinery, or do other dangerous activities while taking glycopyrrolate oral solution.</li> <li>Avoid overheating. See “What are the possible side effects of glycopyrrolate oral solution?”</li> </ul> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">What are the possible side effects of  glycopyrrolate oral solution?</span> <br/> Glycopyrrolate oral solution can cause serious side effects including:<br/> <ul class="Disc"> <li> <span class="Bold">Constipation.</span> Constipation is common with glycopyrrolate oral solution. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of glycopyrrolate oral solution may need to be decreased or stopped.</li> <li> <span class="Bold">Diarrhea and intestinal blockage. </span>Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if your child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking glycopyrrolate oral solution.</li> <li> <span class="Bold">Problems with control of body temperature (overheating or heat stroke).</span> Glycopyrrolate oral solution can cause your child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heat stroke:</li> <li>hot, red skin</li> <li>decreased alertness or passing out (unconsciousness)</li> <li>fast, weak pulse</li> <li>fast, shallow breathing</li> <li>increased body temperature (fever)</li> </ul>The most common side effects of glycopyrrolate oral solution include:<br/> <ul class="Disc"> <li>dry mouth</li> <li>vomiting</li> <li>flushing of the face or skin</li> <li>nasal congestion</li> <li>headache</li> <li>swollen sinuses (sinusitis)</li> <li>upper respiratory tract infection</li> <li>problems urinating, difficulty starting urination</li> </ul>Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of glycopyrrolate oral solution. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">How should I store glycopyrrolate oral solution?</span> <br/> Store glycopyrrolate oral solution between 68°F to 77°F (20°C to 25°C).<br/> <span class="Bold">Keep glycopyrrolate oral solution out of the reach of children.</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">General information about glycopyrrolate oral solution:</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use glycopyrrolate oral solution for a condition for which it was not prescribed. Do not give glycopyrrolate oral solution to other people even if they have the same condition. It may harm them.<br/> This leaflet summarizes the most important information about glycopyrrolate oral solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about glycopyrrolate oral solution that is written for health  professionals.<br/> For more information, go to www.novadozpharma.com or call 1-855-668-2369.<br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle"><span class="Bold">What are the ingredients in glycopyrrolate oral solution?</span> <br/> Active Ingredient: glycopyrrolate<br/> Inactive Ingredients: citric acid monohydrate, glycerin, cherry flavor, methylparaben, propylene glycol, propylparaben, sodium citrate dihydrate, saccharin sodium, sorbitol solution, and purified water.<br/> <br/>The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse Novadoz Pharmaceuticals LLC.<br/> <span class="Bold">Manufactured by: </span> <br/> <span class="Bold">MSN Pharmaceuticals Inc</span> <br/> Piscataway, NJ 08854<br/> <span class="Bold">Distributed by:</span> <br/> <span class="Bold">Novadoz Pharmaceuticals LLC</span> <br/> Piscataway, NJ 08854-3714<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">\n<br/>\n<span class=\"Bold\">PATIENT and CAREGIVER INFORMATION<br/> Glycopyrrolate Oral Solution</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> Please read the Patient and Caregiver Information that comes with glycopyrrolate oral solution before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child’s medical condition or treatment.</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"> <span class=\"Bold\">What is glycopyrrolate oral solution?</span>\n<br/> Glycopyrrolate oral solution is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling.</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">Who should not take glycopyrrolate oral solution?</span>\n<br/> Do not give glycopyrrolate oral solution to anyone who:<br/>\n<ul class=\"Disc\">\n<li>has problems urinating</li>\n<li>has a bowel problem called paralytic ileus</li>\n<li>lacks normal bowel tone or tension</li>\n<li>has severe ulcerative colitis or certain other serious bowel problems with severe ulcerative colitis</li>\n<li>has myasthenia gravis</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">What should I tell my doctor before giving glycopyrrolate oral solution to my child?</span>\n<br/> Tell your doctor if your child:<br/>\n<ul class=\"Disc\">\n<li>has any allergies</li>\n<li>has any stomach or bowel problems, including ulcerative colitis</li>\n<li>has any problems with constipation</li>\n<li>has thyroid problems</li>\n<li>has high blood pressure</li>\n<li>has heart problems or abnormal heart beats</li>\n<li>has a hiatal hernia with gastroesophageal reflux disease (GERD)</li>\n<li>has any eye problems</li>\n<li>has any problems urinating</li>\n<li>has any other medical conditions</li>\n<li>is pregnant or plans to become pregnant. It is not known if glycopyrrolate oral solution can harm an unborn baby.</li>\n<li>is breastfeeding or plans to breastfeed. It is not known if glycopyrrolate passes into breast milk and if it can harm the baby.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">Tell your doctor about all of the medicines that your child takes,</span> including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way glycopyrrolate oral solution works, and glycopyrrolate oral solution may affect how some other medicines work.</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">How should I give glycopyrrolate oral solution?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Give glycopyrrolate oral solution exactly as prescribed by your child’s doctor.</li>\n<li>Give glycopyrrolate oral solution 1 hour before or 2 hours after meals.</li>\n<li>Your doctor will tell you how much (milliliters or mLs) of glycopyrrolate oral solution to give your child.</li>\n<li>Do not change the dose of glycopyrrolate oral solution unless your doctor tells you to.</li>\n<li>You must measure the dose of glycopyrrolate oral solution before giving it to your child. Use a special marked dose measuring cup (available at most pharmacies) to measure the right dose of glycopyrrolate oral solution.</li>\n<li>To help make sure that your child swallows the dose, you should use an oral syringe to give the child each dose of glycopyrrolate oral solution, after you measure the dose needed with a dose measuring cup. Oral syringes are also available at most pharmacies.</li>\n<li>If you have questions about how to measure the dose or how to use an oral syringe, ask your pharmacist or doctor.</li>\n<li>The dose of glycopyrrolate oral solution that is needed to control drooling may be different for each child. Glycopyrrolate oral solution is usually started at a low dose, and slowly increased as directed by your doctor. This slow increase in dose continues until the best dose for your child is reached, to control drooling.</li>\n<li>During this time it is important to stay in close contact with your child’s doctor, and tell the doctor about any side effects that your child has. See “What are the possible side effects of glycopyrrolate oral solution?”</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">What should I avoid while taking glycopyrrolate oral solution?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Glycopyrrolate oral solution may cause sleepiness or blurred vision. Do not drive a car, operate heavy machinery, or do other dangerous activities while taking glycopyrrolate oral solution.</li>\n<li>Avoid overheating. See “What are the possible side effects of glycopyrrolate oral solution?”</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">What are the possible side effects of  glycopyrrolate oral solution?</span>\n<br/> Glycopyrrolate oral solution can cause serious side effects including:<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Constipation.</span> Constipation is common with glycopyrrolate oral solution. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of glycopyrrolate oral solution may need to be decreased or stopped.</li>\n<li>\n<span class=\"Bold\">Diarrhea and intestinal blockage. </span>Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if your child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking glycopyrrolate oral solution.</li>\n<li>\n<span class=\"Bold\">Problems with control of body temperature (overheating or heat stroke).</span> Glycopyrrolate oral solution can cause your child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heat stroke:</li>\n<li>hot, red skin</li>\n<li>decreased alertness or passing out (unconsciousness)</li>\n<li>fast, weak pulse</li>\n<li>fast, shallow breathing</li>\n<li>increased body temperature (fever)</li>\n</ul>The most common side effects of glycopyrrolate oral solution include:<br/>\n<ul class=\"Disc\">\n<li>dry mouth</li>\n<li>vomiting</li>\n<li>flushing of the face or skin</li>\n<li>nasal congestion</li>\n<li>headache</li>\n<li>swollen sinuses (sinusitis)</li>\n<li>upper respiratory tract infection</li>\n<li>problems urinating, difficulty starting urination</li>\n</ul>Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of glycopyrrolate oral solution. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">How should I store glycopyrrolate oral solution?</span>\n<br/> Store glycopyrrolate oral solution between 68°F to 77°F (20°C to 25°C).<br/>\n<span class=\"Bold\">Keep glycopyrrolate oral solution out of the reach of children.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">General information about glycopyrrolate oral solution:</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use glycopyrrolate oral solution for a condition for which it was not prescribed. Do not give glycopyrrolate oral solution to other people even if they have the same condition. It may harm them.<br/> This leaflet summarizes the most important information about glycopyrrolate oral solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about glycopyrrolate oral solution that is written for health  professionals.<br/> For more information, go to www.novadozpharma.com or call 1-855-668-2369.<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">What are the ingredients in glycopyrrolate oral solution?</span>\n<br/> Active Ingredient: glycopyrrolate<br/> Inactive Ingredients: citric acid monohydrate, glycerin, cherry flavor, methylparaben, propylene glycol, propylparaben, sodium citrate dihydrate, saccharin sodium, sorbitol solution, and purified water.<br/> <br/>The brands listed are trademarks or registered trademarks of their respective owners and are not affiliated with and do not endorse Novadoz Pharmaceuticals LLC.<br/>\n<span class=\"Bold\">Manufactured by: </span>\n<br/>\n<span class=\"Bold\">MSN Pharmaceuticals Inc</span>\n<br/> Piscataway, NJ 08854<br/>\n<span class=\"Bold\">Distributed by:</span>\n<br/>\n<span class=\"Bold\">Novadoz Pharmaceuticals LLC</span>\n<br/> Piscataway, NJ 08854-3714<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration                                                                  Revised:06/2022

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration                                                                  Revised:06/2022" }

Glycopyrrolate Oral Solution, 1 mg/5 mL (16 Fl.Oz) Bottle Label:

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Oral Solution, 1 mg/5 mL (16 Fl.Oz) Bottle Label:\n" }

Glycopyrrolate Oral Solution, 1 mg/5 mL (16 Fl.Oz) Carton Label

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Oral Solution, 1 mg/5 mL (16 Fl.Oz) Carton Label\n" }

Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy)." }

Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information  (17)].

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information  (17)]. " }

Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5 to 3 mg per dose based upon weight. For greater detail, see Table 1.

{ "type": "p", "children": [], "text": "Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5 to 7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5 to 3 mg per dose based upon weight. For greater detail, see Table 1." }

During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver.

{ "type": "p", "children": [], "text": "During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver. " }

Glycopyrrolate oral solution should be dosed at least one hour before or two hours after meals.

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution should be dosed at least one hour before or two hours after meals. " }

The presence of high fat food reduces the oral bioavailability of glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3)].

{ "type": "p", "children": [], "text": "The presence of high fat food reduces the oral bioavailability of glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3)]." }

Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily) 

{ "type": "p", "children": [], "text": "\nTable 1: Recommended Dose Titration Schedule (each dose to be given three times daily) \n" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="8.54%"/> <col width="8.32%"/> <col width="8.14%"/> <col width="8.54%"/> <col width="8.12%"/> <col width="8.56%"/> <col width="8.1%"/> <col width="9.66%"/> <col width="7.86%"/> <col width="7.72%"/> <col width="8.08%"/> <col width="8.36%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Weight</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">Dose </span><span class="Bold">Level 1</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">Dose </span><span class="Bold">Level </span><span class="Bold">2</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">Dose </span><span class="Bold">Level </span><span class="Bold">3</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">Dose </span><span class="Bold">Level </span><span class="Bold">4</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">Dose </span><span class="Bold">Level </span><span class="Bold">5</span> <br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle"><span class="Bold">kg</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">lbs</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">(~0.02 mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold"> (~0.04 mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold"> (~0.06 mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold"> (~0.08 mg/kg)</span> <br/> </td><td align="center" class="Rrule" colspan="2" valign="middle"><span class="Bold">(~0.1</span><span class="Bold"></span><span class="Bold"> mg/kg)</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">13 to 17<br/> </td><td align="center" class="Rrule" valign="middle">27 to 38<br/> </td><td align="center" class="Rrule" valign="middle">0.3 mg<br/> </td><td align="center" class="Rrule" valign="middle">1.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">0.6 mg<br/> </td><td align="center" class="Rrule" valign="middle">3 mL<br/> </td><td align="center" class="Rrule" valign="middle">0.9 mg<br/> </td><td align="center" class="Rrule" valign="middle">4.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.2 mg<br/> </td><td align="center" class="Rrule" valign="middle">6 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.5 mg<br/> </td><td align="center" class="Rrule" valign="middle">7.5 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">18 to 22<br/> </td><td align="center" class="Rrule" valign="middle">39 to 49<br/> </td><td align="center" class="Rrule" valign="middle">0.4 mg<br/> </td><td align="center" class="Rrule" valign="middle">2 mL<br/> </td><td align="center" class="Rrule" valign="middle">0.8 mL<br/> </td><td align="center" class="Rrule" valign="middle">4 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.2 mg<br/> </td><td align="center" class="Rrule" valign="middle">6 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.6 mg<br/> </td><td align="center" class="Rrule" valign="middle">8 mL<br/> </td><td align="center" class="Rrule" valign="middle">2 mg<br/> </td><td align="center" class="Rrule" valign="middle">10 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">23 to 27<br/> </td><td align="center" class="Rrule" valign="middle">50 to 60<br/> </td><td align="center" class="Rrule" valign="middle">0.5 mg<br/> </td><td align="center" class="Rrule" valign="middle">2.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">1 mg<br/> </td><td align="center" class="Rrule" valign="middle">5 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.5 mg<br/> </td><td align="center" class="Rrule" valign="middle">7.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">2 mg<br/> </td><td align="center" class="Rrule" valign="middle">10 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.5 mg<br/> </td><td align="center" class="Rrule" valign="middle">12.5 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">28 to 32<br/> </td><td align="center" class="Rrule" valign="middle">61 to 71<br/> </td><td align="center" class="Rrule" valign="middle">0.6 mg<br/> </td><td align="center" class="Rrule" valign="middle">3 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.2 mg<br/> </td><td align="center" class="Rrule" valign="middle">6 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.8 mg<br/> </td><td align="center" class="Rrule" valign="middle">9 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.4 mg<br/> </td><td align="center" class="Rrule" valign="middle">12 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">33 to 37<br/> </td><td align="center" class="Rrule" valign="middle">72 to 82<br/> </td><td align="center" class="Rrule" valign="middle">0.7 mg<br/> </td><td align="center" class="Rrule" valign="middle">3.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.4 mg<br/> </td><td align="center" class="Rrule" valign="middle">7 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.1 mg<br/> </td><td align="center" class="Rrule" valign="middle">10.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.8 mg<br/> </td><td align="center" class="Rrule" valign="middle">14 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">38 to 42<br/> </td><td align="center" class="Rrule" valign="middle">83 to 93<br/> </td><td align="center" class="Rrule" valign="middle">0.8 mg<br/> </td><td align="center" class="Rrule" valign="middle">4 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.6 mg<br/> </td><td align="center" class="Rrule" valign="middle">8 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.4 mg<br/> </td><td align="center" class="Rrule" valign="middle">12 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">43 to 47<br/> </td><td align="center" class="Rrule" valign="middle">94 to 104<br/> </td><td align="center" class="Rrule" valign="middle">0.9 mg<br/> </td><td align="center" class="Rrule" valign="middle">4.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">1.8 mg<br/> </td><td align="center" class="Rrule" valign="middle">9 mL<br/> </td><td align="center" class="Rrule" valign="middle">2.7 mg<br/> </td><td align="center" class="Rrule" valign="middle">13.5 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">≥48<br/> </td><td align="center" class="Rrule" valign="middle">≥105<br/> </td><td align="center" class="Rrule" valign="middle">1  mg<br/> </td><td align="center" class="Rrule" valign="middle">5 mL<br/> </td><td align="center" class="Rrule" valign="middle">2 mg<br/> </td><td align="center" class="Rrule" valign="middle">10 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td><td align="center" class="Rrule" valign="middle">3 mg<br/> </td><td align="center" class="Rrule" valign="middle">15 mL<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\">\n<colgroup>\n<col width=\"8.54%\"/>\n<col width=\"8.32%\"/>\n<col width=\"8.14%\"/>\n<col width=\"8.54%\"/>\n<col width=\"8.12%\"/>\n<col width=\"8.56%\"/>\n<col width=\"8.1%\"/>\n<col width=\"9.66%\"/>\n<col width=\"7.86%\"/>\n<col width=\"7.72%\"/>\n<col width=\"8.08%\"/>\n<col width=\"8.36%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Weight</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Dose </span><span class=\"Bold\">Level 1</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Dose </span><span class=\"Bold\">Level </span><span class=\"Bold\">2</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Dose </span><span class=\"Bold\">Level </span><span class=\"Bold\">3</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Dose </span><span class=\"Bold\">Level </span><span class=\"Bold\">4</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">Dose </span><span class=\"Bold\">Level </span><span class=\"Bold\">5</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">kg</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\">lbs</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">(~0.02 mg/kg)</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\"> (~0.04 mg/kg)</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\"> (~0.06 mg/kg)</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\"> (~0.08 mg/kg)</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"middle\"><span class=\"Bold\">(~0.1</span><span class=\"Bold\"></span><span class=\"Bold\"> mg/kg)</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">13 to 17<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">27 to 38<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.6 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.9 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">4.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">6 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.5 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">7.5 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">18 to 22<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">39 to 49<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.4 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.8 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">4 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">6 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.6 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">8 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">10 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">23 to 27<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">50 to 60<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.5 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.5 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">7.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">10 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.5 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">12.5 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">28 to 32<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">61 to 71<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.6 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">6 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.8 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">9 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.4 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">12 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">33 to 37<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">72 to 82<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.7 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.4 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">7 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.1 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">10.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.8 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">14 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">38 to 42<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">83 to 93<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.8 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">4 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.6 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">8 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.4 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">12 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">43 to 47<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">94 to 104<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">0.9 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">4.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1.8 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">9 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2.7 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">13.5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">≥48<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">≥105<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">1  mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">5 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">10 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">3 mg<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">15 mL<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Glycopyrrolate oral solution is available as a 1 mg/5 mL clear, colorless strawberry flavored solution for oral administration in 16 ounce bottles.

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution is available as a 1 mg/5 mL clear, colorless strawberry flavored solution for oral administration in 16 ounce bottles." }

Glycopyrrolate oral solution is contraindicated in:

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

{ "type": "ul", "children": [ "Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis).", "Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of glycopyrrolate oral solution. " ], "text": "" }

Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see Adverse Reactions (6.1)]. Assess patients for constipation, particularly within 4 to 5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.

Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with glycopyrrolate and evaluate for intestinal obstruction.

In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as glycopyrrolate. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.

Glycopyrrolate may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking glycopyrrolate.

Use glycopyrrolate with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:

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 data described below reflect exposure to glycopyrrolate in 151 subjects, including 20 subjects who participated in an 8-week placebo-controlled study (Study 1) and 137 subjects who participated in a 24-week open-label study (six subjects who received glycopyrrolate  in the placebo-controlled study and 131 new subjects).

Table 2 presents adverse reactions reported by ≥ 15% of glycopyrrolate-treated subjects from the placebo-controlled clinical trial. 

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 2: Adverse Reactions Occurring in ≥ 15% of Glycopyrrolate-Treated Subjects and at a Greater Frequency than Placebo in Study 1</span> </caption> <colgroup> <col width="45.64%"/> <col width="25.7%"/> <col width="28.66%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" valign="top"> <br/> </td><td align="left" class="Rrule" valign="middle"><span class="Bold">Glycopyrrolate (N=20)</span> <br/>n (%)<br/> </td><td align="left" class="Rrule" valign="middle"><span class="Bold">Placebo</span> <br/> <span class="Bold">(N=18)</span> <br/>n (%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Dry Mouth<br/> </td><td align="left" class="Rrule" valign="middle">8 (40%)<br/> </td><td align="left" class="Rrule" valign="middle">2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Vomiting<br/> </td><td align="left" class="Rrule" valign="middle">8 (40%)<br/> </td><td align="left" class="Rrule" valign="middle">2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Constipation<br/> </td><td align="left" class="Rrule" valign="middle">7 (35%)<br/> </td><td align="left" class="Rrule" valign="middle">4 (22%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Flushing<br/> </td><td align="left" class="Rrule" valign="middle">6 (30%)<br/> </td><td align="left" class="Rrule" valign="middle">3 (17%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Nasal Congestion<br/> </td><td align="left" class="Rrule" valign="middle">6 (30%)<br/> </td><td align="left" class="Rrule" valign="middle">2 (11%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Headache<br/> </td><td align="left" class="Rrule" valign="middle">3 (15%)<br/> </td><td align="left" class="Rrule" valign="middle">1 (6%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Sinusitis<br/> </td><td align="left" class="Rrule" valign="middle">3 (15%)<br/> </td><td align="left" class="Rrule" valign="middle">1 (6%)<br/> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" valign="middle">Upper Respiratory Tract Infection<br/> </td><td align="left" class="Rrule" valign="middle">3 (15%)<br/> </td><td align="left" class="Rrule" valign="middle">0<br/> </td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" valign="middle">Urinary Retention<br/> </td><td align="left" class="Rrule" valign="middle">3 (15%)<br/> </td><td align="left" class="Rrule" valign="middle">0<br/> </td> </tr> </tbody> </table></div>

The following adverse reactions occurred at a rate of <2% of patients receiving glycopyrrolate in the open-label study.

        Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue

        General Disorders: Irritability, pain

        Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection

        Investigations: Heart rate increase

        Metabolism and Nutrition: Dehydration

        Nervous System: Headache, convulsion, dysgeusia, nystagmus

        Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered

        Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness

        Skin: Dry skin, pruritus, rash

        Vascular: Pallor

The following adverse reactions have been identified during postapproval use of other formulations of glycopyrrolate for other indications. Because these reactions are 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. 

Additional adverse reactions identified during postapproval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.

Drugs Affected by Reduced GI Transit Time

{ "type": "p", "children": [], "text": "\nDrugs Affected by Reduced GI Transit Time\n" }

Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.  

{ "type": "p", "children": [], "text": "Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.  " }

{ "type": "ul", "children": [ "The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are contraindicated [see Contraindications (4)]. ", "Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is coadministered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules). " ], "text": "" }

Amantadine The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine.

{ "type": "p", "children": [], "text": "\nAmantadine\n\n The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine." }

Drugs Whose Plasma Levels May be Increased by Glycopyrrolate Coadministration of glycopyrrolate may result in increased levels of certain drugs.

{ "type": "p", "children": [], "text": "\nDrugs Whose Plasma Levels May be Increased by Glycopyrrolate\n\n Coadministration of glycopyrrolate may result in increased levels of certain drugs. " }

{ "type": "ul", "children": [ "Atenolol’s bioavailability may be increased with coadministration of glycopyrrolate. A reduction in the atenolol dose may be needed. ", "Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin’s pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted. " ], "text": "" }

Drugs Whose Plasma Levels May be Decreased by Glycopyrrolate Coadministration of glycopyrrolate may result in decreased levels of certain drugs.

{ "type": "p", "children": [], "text": "\nDrugs Whose Plasma Levels May be Decreased by Glycopyrrolate\n\n Coadministration of glycopyrrolate may result in decreased levels of certain drugs. " }

{ "type": "ul", "children": [ "Haloperidol’s serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia. Closely monitor patients if coadministration cannot be avoided. ", "Levodopa’s therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa." ], "text": "" }

Risk Summary

There are no available data in pregnant women for glycopyrrolate to inform decisions concerning any drug-associated risks. In pregnant rats, daily oral administration of glycopyrrolate during organogenesis at dose exposures 2.5 to 113 times the exposure at the maximum recommended human dose (MRHD) did not result in an increased incidence of gross external or visceral defects [see Data]. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis at dose exposures equivalent to up to approximately 7.8 times the exposure at the MRHD, no adverse effects on embryo-fetal development were seen. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Animal Data

Glycopyrrolate was orally administered to pregnant rats at dosages of 50, 200, and 400 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Glycopyrrolate had no effect on maternal survival, but significantly reduced mean maternal body weight gain over the period of dosing at all dosages evaluated. Mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day dose groups. There were two litters with all resorbed fetuses in the 400 mg/kg/day dose group. There were no effects of treatment on the incidence of gross external or visceral defects. Minor treatment-related skeletal effects included reduced ossification of various bones in the 200 and 400 mg/kg/day dose groups; these skeletal effects were likely secondary to maternal toxicity.

Glycopyrrolate was intravenously administered to pregnant rabbits at dosages of 0.1, 0.5, and 1 mg/kg/day during the period of organogenesis. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 0.8, 4.6, and 7.8 times, respectively, the estimated systemic exposure in humans at the MRHD. Glycopyrrolate did not affect maternal survival under the conditions of this study. Mean maternal body weight gain and mean food consumption over the period of dosing were lower than the corresponding control value in the 0.5 and 1 mg/kg/day treatment groups. There were no effects of treatment on fetal parameters, including fetal survival, mean fetal weight, and the incidence of external, visceral, or skeletal defects.

Female rats that were pregnant or nursing were orally dosed with glycopyrrolate daily at dosages of 0, 50, 200, or 400 mg/kg/day, beginning on day 7 of gestation, and continuing until day 20 of lactation. These dosages resulted in systemic exposures (estimated AUC0-inf values) approximately 2.5, 23, and 113 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses). Mean body weight of pups in all treatment groups was reduced compared to the control group during the period of nursing, but eventually recovered to be comparable to the control group, post-weaning. No other notable delivery or litter parameters were affected by treatment in any group, including no effects on mean duration of gestation or mean numbers of live pups per litter. No treatment-related effects on survival or adverse clinical signs were observed in pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups.

Risk Summary There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glycopyrrolate and any potential adverse effects on the breastfed infant from glycopyrrolate or from the underlying maternal condition.

Glycopyrrolate was evaluated for chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling. Glycopyrrolate  has not been studied in subjects under the age of 3 years.

Clinical studies of glycopyrrolate did not include subjects aged 65 and over.

Because glycopyrrolate is largely renally eliminated, glycopyrrolate should be used with caution in patients with renal impairment [see Clinical Pharmacology (12.3)].

Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:

{ "type": "p", "children": [], "text": "Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:" }

{ "type": "ul", "children": [ "Maintain an open airway, providing ventilation as necessary.", "Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage. ", "Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus.", " Administering activated charcoal orally as appropriate." ], "text": "" }

Glycopyrrolate is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate USP per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is:

{ "type": "p", "children": [], "text": "Glycopyrrolate is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate USP per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is:" }

The molecular formula for glycopyrrolate is C19H28BrNO3 and the molecular weight is 398.33. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate).

{ "type": "p", "children": [], "text": " The molecular formula for glycopyrrolate is C19H28BrNO3 and the molecular weight is 398.33. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate)." }

Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

Absorption

In a parallel study of children (n=6 per group) aged 7 to 14 years undergoing intraocular surgery, subjects received either intravenous (IV) or oral glycopyrrolate as a premedication. The mean absolute bioavailability of oral glycopyrrolate tablets was low (approximately 3%) and highly variable among subjects (range 1.3 to 13.3%). A similar pattern of low and variable relative bioavailability is seen in adults.

Analysis of population pharmacokinetic data from normal adults and children with cerebral palsy associated chronic moderate to severe drooling failed to demonstrate linear pharmacokinetics across the dose range. In the same analysis, population estimates of the apparent oral clearance (scaled by weight in children and adults) ranged from 5.28 to 38.95 L/hr/kg for healthy adults and 8.07 to 25.65 L/hr/kg for patients with cerebral palsy, a reflection of the low and highly variable oral bioavailability of glycopyrrolate.

Absorption of glycopyrrolate (fasting) was compared to that of a marketed glycopyrrolate oral tablet. The Cmax after oral solution administration was 23% lower compared to tablet administration and AUC0-inf was 28% lower after oral solution administration. Mean Cmax after oral solution administration in the fasting state was 0.318 ng/mL, and mean AUC0-24 was 1.74 ng·hr/mL. Mean time to maximum plasma concentration for glycopyrrolate was 3.1 hours, and mean plasma half-life was 3.0 hours.

In healthy adults, a high fat meal was shown to significantly affect the absorption of glycopyrrolate oral solution (10 mL, 1 mg/5 mL). The mean Cmax under fed high fat meal conditions was approximately 74% lower than the Cmax observed under fasting conditions. Similarly, mean AUC0-T was reduced by about 78% by the high fat meal compared with the fasting AUC0-T. A high fat meal markedly reduces the oral bioavailability of glycopyrrolate. Therefore, glycopyrrolate should be dosed at least one hour before or two hours after meals. Pharmacokinetic results (mean ± SD) are described in Table 3.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 3:  Pharmacokinetic Parameters (mean±SD) for Glycopyrrolate, Fasting and Fed, in  Healthy Adults</span> </caption> <colgroup> <col width="15.58%"/> <col width="17.12%"/> <col width="17.3%"/> <col width="17.3%"/> <col width="16.54%"/> <col width="16.16%"/> </colgroup> <tfoot> <tr class="First Last"> <td colspan="6">* n=35</td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" valign="top"> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">C<span class="Sub">max</span></span> <br/> <span class="Bold">(ng/mL</span><span class="Bold">)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">T<span class="Sub">max</span></span> <br/> <span class="Bold">(hrs)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">AUC<span class="Sub">0-T</span></span> <br/> <span class="Bold">(ng·hr/mL)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">AUC<span class="Sub">0-Inf</span> (ng·hr/mL)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">T<span class="Sub">1/2</span></span> <br/> <span class="Bold">(hrs)</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Fasting</span> <br/> <span class="Bold">(n=37)</span> <br/> </td><td align="center" class="Rrule" valign="middle">0.318 ± 0.190<br/> </td><td align="center" class="Rrule" valign="middle">3.10 ± 1.08<br/> </td><td align="center" class="Rrule" valign="middle">1.74 ± 1.07<br/> </td><td align="center" class="Rrule" valign="middle">1.81 ± 1.09<br/> </td><td align="center" class="Rrule" valign="middle">3.0 ± 1.2<br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Fed</span> <br/> <span class="Bold">(n=36)</span> <br/> </td><td align="center" class="Rrule" valign="middle">0.084 ± 0.081<br/> </td><td align="center" class="Rrule" valign="middle">2.60 ± 1.12<br/> </td><td align="center" class="Rrule" valign="middle">0.38 ± 0.14<br/> </td><td align="center" class="Rrule" valign="middle">0.46 ± 0.13*<br/> </td><td align="center" class="Rrule" valign="middle">3.2 ± 1.1*<br/> </td> </tr> </tbody> </table></div>

Distribution

After IV administration, glycopyrrolate has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged 60 to 75 years, the volume of distribution was lower (0.42 L/kg +/- 0.22).

Metabolism

In adult patients who underwent surgery for cholelithiasis and were given a single IV dose of tritiated glycopyrrolate, approximately 85% of total radioactivity was excreted in urine and <5% was present in T-tube drainage of bile. In both urine and bile, >80% of the radioactivity corresponded to unchanged drug. These data suggest a small proportion of IV glycopyrrolate is excreted as one or more metabolites.

Elimination

Approximately 65 to 80% of an IV glycopyrrolate dose was eliminated unchanged in urine in adults. In two studies, after IV administration to pediatric patients ages 1 to 14 years, mean clearance values ranged from 1.01 to 1.41 L/kg/hr (range 0.32 to 2.22 L/kg/hr). In adults, IV clearance values were 0.54 ± 0.14 L/kg/hr.

Pediatrics

The estimated apparent clearance of glycopyrrolate from a population pharmacokinetic analysis (scaled by weight in children and adults) of oral and IV data was found to be 13.2 L/hr/kg or 92.7 L/hr for a typical 70 kg subject. In the same population based analysis, gender was not identified as having an effect on either glycopyrrolate clearance or systemic exposure.

Gender

Population pharmacokinetic evaluation of adults and children administered IV or oral glycopyrrolate identified no effect of gender on glycopyrrolate clearance or systemic exposure.

Race

The pharmacokinetics of glycopyrrolate by race has not been characterized.

Elderly

Glycopyrrolate pharmacokinetics have not been characterized in the elderly.

Renal Impairment

In one study, glycopyrrolate 4 mcg/kg was administered intravenously in uremic patients undergoing renal transplantation surgery. Mean AUC (10.6 mcg·h/L), mean plasma clearance (0.43 L/hr/kg) and mean 3-hour urinary excretion (0.7%) for glycopyrrolate were significantly different than those of control patients (3.73 mcg·h/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that elimination of glycopyrrolate is severely impaired in patients with renal failure.

Hepatic Impairment

Glycopyrrolate is largely renally eliminated. The pharmacokinetics of glycopyrrolate have not been evaluated in patients with hepatic impairment.

When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, resulting in systemic exposures (estimated AUC0-inf values) approximately 0.1, 0.3, and 0.8 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses), no significant changes in tumor incidence were observed when compared to control.

When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, resulting in systemic exposures approximately 0.2, 0.8, and 2 times, respectively, the estimated systemic exposure in humans at the MRHD, no significant changes in tumor incidence were observed when compared to control.

Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay.

Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage, resulting in systemic exposures (estimated AUC0-inf values) in males and females up to approximately 11 and 15 times, respectively, the estimated systemic exposure in humans at the MRHD. No treatment-related effects on fertility or reproductive parameters were observed in either gender in this study.

Glycopyrrolate was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3 to 23 years; thirty-six subjects were aged 3 to 16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). Subjects were randomized in a 1:1 fashion to receive glycopyrrolate or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5 to 7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day.

{ "type": "p", "children": [], "text": "Glycopyrrolate was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3 to 23 years; thirty-six subjects were aged 3 to 16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). Subjects were randomized in a 1:1 fashion to receive glycopyrrolate or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5 to 7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day. " }

Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS), which is presented below. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy.

{ "type": "p", "children": [], "text": "Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS), which is presented below. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy. " }

Modified Teacher’s Drooling Scale

{ "type": "p", "children": [], "text": "\nModified Teacher’s Drooling Scale\n" }

1= Dry: never drools

{ "type": "p", "children": [], "text": "1= Dry: never drools " }

2= Mild: only the lips are wet; occasionally

{ "type": "p", "children": [], "text": "2= Mild: only the lips are wet; occasionally " }

3= Mild: only the lips are wet; frequently

{ "type": "p", "children": [], "text": "3= Mild: only the lips are wet; frequently" }

4= Moderate: wet on the lips and chin; occasionally

{ "type": "p", "children": [], "text": "4= Moderate: wet on the lips and chin; occasionally" }

 5= Moderate: wet on the lips and chin; frequently

{ "type": "p", "children": [], "text": " 5= Moderate: wet on the lips and chin; frequently" }

6= Severe: drools to the extent that clothing becomes damp; occasionally

{ "type": "p", "children": [], "text": "6= Severe: drools to the extent that clothing becomes damp; occasionally " }

7= Severe: drools to the extent that clothing becomes damp; frequently

{ "type": "p", "children": [], "text": "7= Severe: drools to the extent that clothing becomes damp; frequently" }

8= Profuse: clothing, hands, tray, and objects become wet; occasionally

{ "type": "p", "children": [], "text": "8= Profuse: clothing, hands, tray, and objects become wet; occasionally " }

9= Profuse: clothing, hands, tray, and objects become wet; frequently

{ "type": "p", "children": [], "text": "9= Profuse: clothing, hands, tray, and objects become wet; frequently " }

Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8.

{ "type": "p", "children": [], "text": "Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8." }

Table 4: Percentage of Responders at Week 8

{ "type": "p", "children": [], "text": "\nTable 4: Percentage of Responders at Week 8\n" }

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="49.52%"/> <col width="50.48%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="bottom"><span class="Bold">Glycopyrrolate Group </span> <br/> </td><td align="center" class="Rrule" valign="bottom"><span class="Bold">Placebo Group</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">(N=20)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">(N=18)</span> <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">15/20 (75%)<br/> </td><td align="center" class="Rrule" valign="middle">2/18 (11%)<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\">\n<colgroup>\n<col width=\"49.52%\"/>\n<col width=\"50.48%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"bottom\"><span class=\"Bold\">Glycopyrrolate Group </span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\"><span class=\"Bold\">Placebo Group</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\"><span class=\"Bold\">(N=20)</span>\n<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\"><span class=\"Bold\">(N=18)</span>\n<br/>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\" valign=\"middle\">15/20 (75%)<br/>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">2/18 (11%)<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Glycopyrrolate Oral Solution 1 mg/5 mL is clear, colorless strawberry flavored solution supplied as follows:

{ "type": "p", "children": [], "text": "Glycopyrrolate Oral Solution 1 mg/5 mL is clear, colorless strawberry flavored solution supplied as follows:" }

                 16 oz.  (473 mL) bottle                   NDC 59651-435-47

{ "type": "p", "children": [], "text": "                 16 oz.  (473 mL) bottle                   NDC 59651-435-47" }

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

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

See FDA-approved patient labeling (Patient Information)

{ "type": "p", "children": [], "text": "See FDA-approved patient labeling (Patient Information)" }

{ "type": "ul", "children": [ "Advise patients/caregivers to measure glycopyrrolate with an accurate measuring device. A household teaspoon is not an accurate measuring device. Patients/caregivers should use a dosing cup available in pharmacies to accurately measure the correct milliliter dose. An oral syringe, also available in pharmacies, should be used to dispense glycopyrrolate into the child’s mouth from the cup. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.  ", "Administering glycopyrrolate with a high fat meal substantially reduces the amount of glycopyrrolate absorbed. Administer glycopyrrolate at least one hour before or two hours after meals.  ", "Glycopyrrolate is started at a low dose and gradually titrated over a period of weeks based on therapeutic response and adverse reactions. Patients/caregivers should not increase the dose without the physician’s permission.  ", "Common adverse reactions from glycopyrrolate include overly dry mouth, constipation, vomiting, flushing of the skin or face, and urinary retention. Side effects can sometimes be difficult to detect in some patients with neurologic problems who cannot adequately communicate how they feel. If side effects become troublesome after increasing a dose, decrease the dose to the prior one and contact your physician. ", "Constipation is the most common side effect of glycopyrrolate, and if constipation occurs, stop administering glycopyrrolate to the patient and call their healthcare practitioner.  ", "Inability of the patient to urinate, dry diapers or undergarments, irritability or crying may be signs of urinary retention, and if urinary retention occurs, patients/caregivers should stop administering glycopyrrolate and call their healthcare practitioner.  ", "If the patient develops a skin rash, hives or an allergic reaction, parents/caregivers should stop administering glycopyrrolate and call their healthcare practitioner as this could be a sign of hypersensitivity to this product.  ", "Drugs like glycopyrrolate can reduce sweating, and if the patient is in a hot environment and flushing of the skin occurs this may be due to overheating. Avoid exposure of the patient to hot or very warm environmental temperatures to avoid overheating and the possibility of heat exhaustion or heat stroke." ], "text": "" }

Glycopyrrolate (glye" koe pir' oh late)

{ "type": "p", "children": [], "text": "\nGlycopyrrolate (glye\" koe pir' oh late)\n" }

Oral Solution

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

Please read the Patient and Caregiver Information that comes with glycopyrrolate oral solution before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child’s medical condition or treatment.

{ "type": "p", "children": [], "text": "Please read the Patient and Caregiver Information that comes with glycopyrrolate oral solution before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child’s medical condition or treatment. " }

What is glycopyrrolate oral solution?

{ "type": "p", "children": [], "text": "\nWhat is glycopyrrolate oral solution? \n" }

Glycopyrrolate oral solution is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling.

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling. " }

Who should not take glycopyrrolate oral solution? Do not give glycopyrrolate oral solution to anyone who:

{ "type": "p", "children": [], "text": "\nWho should not take glycopyrrolate oral solution?\n\n Do not give glycopyrrolate oral solution to anyone who: " }

{ "type": "ul", "children": [ "has problems urinating ", "has a bowel problem called paralytic ileus ", "lacks normal bowel tone or tension", "has severe ulcerative colitis or certain other serious bowel problems with severe ulcerative colitis", "has myasthenia gravis" ], "text": "" }

What should I tell my doctor before giving glycopyrrolate oral solution to my child?

{ "type": "p", "children": [], "text": "\nWhat should I tell my doctor before giving glycopyrrolate oral solution to my child?\n" }

Tell your doctor if your child:

{ "type": "p", "children": [], "text": "Tell your doctor if your child:" }

{ "type": "ul", "children": [ "has any allergies", "has any stomach or bowel problems, including ulcerative colitis ", "has any problems with constipation", "has thyroid problems ", "has high blood pressure", "has heart problems or abnormal heart beats ", "has a hiatal hernia with gastroesophageal reflux disease (GERD) ", "has any eye problems ", "has any problems urinating ", "has any other medical conditions ", "is pregnant or plans to become pregnant. It is not known if glycopyrrolate oral solution can harm an unborn baby. ", "is breastfeeding or plans to breastfeed. It is not known if glycopyrrolate passes into breast milk and if it can harm the baby." ], "text": "" }

Tell your doctor about all of the medicines that your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way glycopyrrolate oral solution works, and glycopyrrolate oral solution may affect how some other medicines work.

{ "type": "p", "children": [], "text": "\nTell your doctor about all of the medicines that your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way glycopyrrolate oral solution works, and glycopyrrolate oral solution may affect how some other medicines work." }

How should I give glycopyrrolate oral solution?

{ "type": "p", "children": [], "text": "\nHow should I give glycopyrrolate oral solution?\n" }

{ "type": "ul", "children": [ "Give glycopyrrolate oral solution exactly as prescribed by your child’s doctor.", "Give glycopyrrolate oral solution 1 hour before or 2 hours after meals. ", "Your doctor will tell you how much (milliliters or mLs) of glycopyrrolate oral solution to give your child.", "Do not change the dose of glycopyrrolate oral solution unless your doctor tells you to. ", "You must measure the dose of glycopyrrolate oral solution before giving it to your child. Use a special marked dose measuring cup (available at most pharmacies) to measure the right dose of glycopyrrolate oral solution.", "To help make sure that your child swallows the dose, you should use an oral syringe to give the child each dose of glycopyrrolate oral solution, after you measure the dose needed with a dose measuring cup. Oral syringes are also available at most pharmacies.", "If you have questions about how to measure the dose or how to use an oral syringe, ask your pharmacist or doctor. ", "The dose of glycopyrrolate oral solution that is needed to control drooling may be different for each child. Glycopyrrolate oral solution is usually started at a low dose, and slowly increased as directed by your doctor. This slow increase in dose continues until the best dose for your child is reached, to control drooling. ", "During this time it is important to stay in close contact with your child’s doctor, and tell the doctor about any side effects that your child has. See “What are the possible side effects of glycopyrrolate oral solution?”" ], "text": "" }

What should I avoid while taking glycopyrrolate oral solution?

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

{ "type": "ul", "children": [ "Glycopyrrolate oral solution may cause sleepiness or blurred vision. Do not drive a car, operate heavy machinery, or do other dangerous activities while taking glycopyrrolate oral solution.", "Avoid overheating. See “What are the possible side effects of glycopyrrolate oral solution?”" ], "text": "" }

What are the possible side effects of glycopyrrolate oral solution?

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

Glycopyrrolate oral solution can cause serious side effects including:

{ "type": "p", "children": [], "text": "Glycopyrrolate oral solution can cause serious side effects including:" }

{ "type": "ul", "children": [ "\n Constipation. Constipation is common with glycopyrrolate oral solution. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of glycopyrrolate oral solution may need to be decreased or stopped.", "\nDiarrhea and intestinal blockage. Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if your child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking glycopyrrolate oral solution. ", "\nProblems with control of body temperature (overheating or heat stroke). Gycopyrrolate oral solution can cause your child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heatstroke: \nhot, red skin  \ndecreased alertness or passing out (unconsciousness) \nfast, weak pulse  \nfast, shallow breathing \nincreased body temperature (fever)  \n\n" ], "text": "" }

The most common side effects of glycopyrrolate oral solution include:

{ "type": "p", "children": [], "text": "The most common side effects of glycopyrrolate oral solution include:" }

{ "type": "ul", "children": [ " dry mouth  ", " vomiting                   ", " flushing of the face or skin  ", " nasal congestion ", " headache  ", " swollen sinuses (sinusitis) ", " upper respiratory tract infection ", " problems urinating, difficulty starting urination" ], "text": "" }

Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of glycopyrrolate oral solution.

{ "type": "p", "children": [], "text": "Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of glycopyrrolate oral solution. " }

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

How should I store glycopyrrolate oral solution?

{ "type": "p", "children": [], "text": "\nHow should I store glycopyrrolate oral solution?\n" }

Store glycopyrrolate oral solution between 68°F to 77°F (20°C to 25°C).

{ "type": "p", "children": [], "text": "Store glycopyrrolate oral solution between 68°F to 77°F (20°C to 25°C). " }

Keep glycopyrrolate oral solution out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep glycopyrrolate oral solution out of the reach of children.\n" }

General information about glycopyrrolate oral solution:

{ "type": "p", "children": [], "text": "\n General information about glycopyrrolate oral solution:\n" }

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use glycopyrrolate oral solution for a condition for which it was not prescribed. Do not give glycopyrrolate oral solution 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 Patient Information leaflet. Do not use glycopyrrolate oral solution for a condition for which it was not prescribed. Do not give glycopyrrolate oral solution to other people even if they have the same condition. It may harm them. " }

This leaflet summarizes the most important information about glycopyrrolate oral solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about glycopyrrolate oral solution that is written for health professionals.

{ "type": "p", "children": [], "text": "This leaflet summarizes the most important information about glycopyrrolate oral solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about glycopyrrolate oral solution that is written for health professionals. " }

For more information, call Aurobindo Pharma USA, Inc. 1-866-850-2876. What are the ingredients in glycopyrrolate oral solution? Active Ingredient: glycopyrrolate Inactive Ingredients: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate). Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 04/2025

{ "type": "p", "children": [], "text": "For more information, call Aurobindo Pharma USA, Inc. 1-866-850-2876.\n\n What are the ingredients in glycopyrrolate oral solution?\n\n Active Ingredient: glycopyrrolate\n\n Inactive Ingredients: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate).\n Distributed by:\nAurobindo Pharma USA, Inc.\n279 Princeton-Hightstown RoadEast Windsor, NJ 08520\n Manufactured by:\nAurobindo Pharma Limited\nHyderabad-500 032, India\n Revised: 04/2025" }

NDC 59651-435-47

{ "type": "p", "children": [], "text": "\nNDC 59651-435-47\n" }

Rx only

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

Glycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL)

{ "type": "p", "children": [], "text": "\nGlycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL)\n" }

For Oral Use Only                                    16 fl. oz. Aurobindo                  (473 mL)

{ "type": "p", "children": [], "text": "\nFor Oral Use Only                                    16 fl. oz. Aurobindo                  (473 mL)\n\n" }

NDC 59651-435-47 Rx only Glycopyrrolate Oral Solution 1 mg/5 mL (0.2 mg/mL) For Oral Use Only AUROBINDO               16 fl. oz.                                        (473 mL)  

{ "type": "p", "children": [], "text": "NDC 59651-435-47\n\nRx only\n\n\n Glycopyrrolate Oral Solution\n 1 mg/5 mL (0.2 mg/mL)\n For Oral Use Only\n\nAUROBINDO               16 fl. oz.                                        (473 mL)  \n\n\n\n\n" }

Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer." }

Limitations of Use

{ "type": "p", "children": [], "text": "\nLimitations of Use\n" }

Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established." }

{ "type": "ul", "children": [ "Glycopyrrolate tablets USP, 1 mg are white to off-white, round, flat faced bevel edged tablets debossed \"T\" above and \"12\" below the bisect on one side and plain on the other side.", "Glycopyrrolate tablets USP, 2 mg are white to off-white, round, flat faced bevel edged tablets debossed \"T\" above and \"13\" below the bisect on one side and plain on the other side." ], "text": "" }

Glycopyrrolate tablets are contraindicated in:

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets are contraindicated in:" }

{ "type": "ul", "children": [ "Patients at risk for anticholinergic toxicity due to an underlying medical condition, including:\nGlaucoma [see Warnings and Precautions (5.1)]\nObstructive uropathies, including prostatic hypertrophy\nMechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [see Warnings and Precautions (5.2)]\nGastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [see Warnings and Precautions (5.3)]\nBleeding gastrointestinal ulcer\nActive inflammatory or infectious colitis which can lead to toxic megacolon\nHistory of or current toxic megacolon\nMyasthenia gravis\n\n", "Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in Glycopyrrolate tablet 1 mg and Glycopyrrolate tablet 2 mg [see Adverse Reactions (6) and Description (11)]" ], "text": "" }

Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. Instruct patients to discontinue Glycopyrrolate tablets and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [see Contraindications (4)].

Glycopyrrolate tablets may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. If partial or complete intestinal obstruction is suspected, discontinue the use of Glycopyrrolate tablets and evaluate for potential intestinal obstruction [see Contraindications (4)].

Glycopyrrolate reduces gastrointestinal motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon [see Contraindications (4)]. The risk of  gastrointestinal adverse reactions is further increased with the use of other anticholinergics and other medications that decrease gastrointestinal peristalsis.

Monitor patients for symptoms of decreased gastrointestinal motility. Concomitant use of Glycopyrrolate tablets and other anticholinergics or other medications that decrease GI peristalsis is not recommended [see Drug Interactions (7.2)].

Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work [see Adverse Reactions (6)]. Concomitant use of other drugs that have anticholinergic properties may increase these effects [see Drug Interactions (7.1)].

Inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that Glycopyrrolate tablets does not affect them adversely.

Discontinue Glycopyrrolate tablets if signs or symptoms of cognitive or visual impairment develop.

In the presence of a high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of Glycopyrrolate tablets due to decreased sweating, particularly in geriatric patients [see Adverse Reactions (6)]. Advise patients to avoid exposure to hot or very warm environmental temperatures when taking Glycopyrrolate tablets. Glycopyrrolate tablets are not recommended in geriatric patients [see Warnings and Precautions (5.7)].

Glycopyrrolate tablets are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications [see Drug Interactions (7.1)].

Geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. Glycopyrrolate tablet 1 mg and Glycopyrrolate tablet 2 mg are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [see Contraindications(4), Warnings and Precautions (5.2,5.5), Adverse Reactions (6) and Use in Specific Populations (8.5)].

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

{ "type": "p", "children": [], "text": "The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:" }

•     Precipitation of Acute Glaucoma [see Warnings and Precautions (5.1)]

{ "type": "p", "children": [], "text": "•     Precipitation of Acute Glaucoma [see Warnings and Precautions (5.1)]" }

•     Partial or Complete Mechanical Intestinal Obstruction [see Warnings and Precautions (5.2)]

{ "type": "p", "children": [], "text": "•     Partial or Complete Mechanical Intestinal Obstruction [see Warnings and Precautions (5.2)]" }

•     Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)]

{ "type": "p", "children": [], "text": "•     Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3)]" }

•     Cognitive and Visual Adverse Reactions [see Warnings and Precautions (5.4)]

{ "type": "p", "children": [], "text": "•     Cognitive and Visual Adverse Reactions [see Warnings and Precautions (5.4)]" }

•     Heat Prostration at High Environmental Temperatures [see Warnings and Precautions (5.5)]

{ "type": "p", "children": [], "text": "•     Heat Prostration at High Environmental Temperatures [see Warnings and Precautions (5.5)]" }

•     Other Conditions Exacerbated by Anticholinergic Adverse Reactions [see Warnings and Precautions (5.6)]

{ "type": "p", "children": [], "text": "•     Other Conditions Exacerbated by Anticholinergic Adverse Reactions [see Warnings and Precautions (5.6)]" }

•     Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients [see Warnings and Precautions (5.7)]

{ "type": "p", "children": [], "text": "•     Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients [see Warnings and Precautions (5.7)]" }

The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or postmarketing reports.

{ "type": "p", "children": [], "text": "The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or postmarketing reports." }

Because some of these reactions are 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": "Because some of these reactions are 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." }

Cardiac Disorders: chest pain, hypertension, tachycardia

{ "type": "p", "children": [], "text": "\nCardiac Disorders: chest pain, hypertension, tachycardia" }

Endocrine Disorders: decreased sweating

{ "type": "p", "children": [], "text": "\nEndocrine Disorders: decreased sweating" }

Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension

{ "type": "p", "children": [], "text": "\nEye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension" }

Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting

{ "type": "p", "children": [], "text": "\nGastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting" }

Immune System Disorders: anaphylaxis [see Contraindications (4)]

{ "type": "p", "children": [], "text": "\nImmune System Disorders: anaphylaxis [see Contraindications (4)]" }

Nervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness

{ "type": "p", "children": [], "text": "\nNervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness" }

Respiratory Disorders: respiratory depression, throat irritation

{ "type": "p", "children": [], "text": "\nRespiratory Disorders: respiratory depression, throat irritation" }

Renal and Urinary Disorders: urinary hesitancy, urinary retention

{ "type": "p", "children": [], "text": "\nRenal and Urinary Disorders: urinary hesitancy, urinary retention" }

Reproductive System and Breast Disorders: impotence, suppression of lactation

{ "type": "p", "children": [], "text": "\nReproductive System and Breast Disorders: impotence, suppression of lactation" }

Vascular Disorders: flushing

{ "type": "p", "children": [], "text": "\nVascular Disorders: flushing" }

There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e.g., tricyclic antidepressants, anti-epileptics, class I antiarrhythmics, antispasmodics, amantadine) resulting in increased anticholinergic adverse reactions. Co-administration of antipsychotics with glycopyrrolate may lead to worsening of tardive dyskinesia. Glycopyrrolate tablets are not recommended in patients taking other anticholinergic drugs [see Warnings and Precautions(5.3, 5.4,5.6)].

Decreased gastrointestinal motility by glycopyrrolate may impact absorption of other drugs leading to increased or decreased drug exposure. Glycopyrrolate tablets are not recommended in patients taking other drugs that are affected by altered gastrointestinal motility [see Warnings and Precautions (5.3)].

Oral glycopyrrolate may worsen gastrointestinal mucosal injury reported with solid oral dosage forms of potassium chloride due to decreased gastric motility and increased transit time, leading to prolonged contact with the gastrointestinal mucosa. Glycopyrrolate tablets are not recommended in patients taking solid oral dosage forms of potassium chloride.

Risk Summary

Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animalstudies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits. A pre-and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean body weight that recovered post nursing, with no other developmental effects observed (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.

Data

Animal Data

At non-maternally toxic doses of oral glycopyrrolate, there were no effects on embryo-fetal development or toxicity in rats or rabbits. A pre-and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean body weight that recovered post nursing, with no other developmental effects observed.

In a published reproductive and developmental study, male and female rats were administered glycopyrrolate in the diet at 0 mg/kg/day, 32.5 mg/kg/day, 63 mg/kg/day, and 130 mg/kg/day for 3 weeks to 5 weeks and through up to three consecutive litters. There was no indication of abnormalities in the pups of treated dams. There was a decreased rate of conception and in survival rate at weaning for all treated animals in a dose-related manner. Diminished rates of conception may be due to diminished seminal secretion [see Nonclinical Toxicology (13.1)].

Risk Summary

There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Glycopyrrolate tablets and any potential adverse effects on the breastfed infant from Glycopyrrolate tablets.

Safety and effectiveness in pediatric patients have not been established.

Geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures; therefore, Glycopyrrolate tablets are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [see Contraindications (4) and Warnings and Precautions (5)].

Glycopyrrolate is substantially excreted by the kidneys [see Clinical Pharmacology (12.3)].

Monitor patients with renal impairment for anticholinergic adverse reactions [see Adverse Reactions (6)]. If anticholinergic adverse reactions occur, discontinue Glycopyrrolate tablets.

Signs and symptoms of glycopyrrolate overdosage are related to excessive anti-muscarinic anticholinergic activity and are generally peripheral (e.g., flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation, and light sensitivity due to mydriasis), but central nervous system toxicity (agitation, seizures, hyperthermia) may also occur.

{ "type": "p", "children": [], "text": "Signs and symptoms of glycopyrrolate overdosage are related to excessive anti-muscarinic anticholinergic activity and are generally peripheral (e.g., flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation, and light sensitivity due to mydriasis), but central nervous system toxicity (agitation, seizures, hyperthermia) may also occur." }

If over-exposure occurs, call the Poison Control Center at 1-800-222-1222 for current information on the management of glycopyrrolate poisoning and overdosage.

{ "type": "p", "children": [], "text": "\nIf over-exposure occurs, call the Poison Control Center at 1-800-222-1222 for current information on the management of glycopyrrolate poisoning and overdosage.\n" }

Management of glycopyrrolate overdosage is based upon presenting signs and symptoms, including close observation for severe or life-threatening complications which may require respiratory and cardiovascular monitoring and support. Consider administration of activated charcoal and/or use of a reversible anticholinesterase as appropriate or recommended by Poison Control.

{ "type": "p", "children": [], "text": "Management of glycopyrrolate overdosage is based upon presenting signs and symptoms, including close observation for severe or life-threatening complications which may require respiratory and cardiovascular monitoring and support. Consider administration of activated charcoal and/or use of a reversible anticholinesterase as appropriate or recommended by Poison Control." }

Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:" }

Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.

{ "type": "p", "children": [], "text": "Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate." }

Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.

No formal pharmacodynamic studies have been conducted with Glycopyrrolate tablets.

Patients with Renal Impairment

In the published literature, glycopyrrolate 4 mcg/kg was administered intravenously (Glycopyrrolate tablets are not recommended for intravenous use) in uremic patients undergoing renal transplantation surgery. The mean AUC (10.6 mcg·h/L) and 24-hour urinary excretion (7%) for glycopyrrolate were significantly different from normal healthy adult subjects undergoing general surgery (3.7 mcg·h/L, and 65%, respectively) [see Use in Specific Populations (8.6)].

Reproduction studies in rats resulted in diminished rates of conception in a dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate.

Glycopyrrolate tablets USP 1 mg are white to off-white, round, flat faced bevel edged tablets debossed "T" above and "12" below the bisect on one side and plain on the other side.

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets USP 1 mg are white to off-white, round, flat faced bevel edged tablets debossed \"T\" above and \"12\" below the bisect on one side and plain on the other side." }

•  Available in bottles of 100 (NDC 70752-108-10).

{ "type": "p", "children": [], "text": "•  Available in bottles of 100 (NDC 70752-108-10)." }

•  Available in bottles of 1000 (NDC 70752-108-11).

{ "type": "p", "children": [], "text": "•  Available in bottles of 1000 (NDC 70752-108-11)." }

Glycopyrrolate tablets USP 2 mg are white to off-white, round, flat faced bevel edged tablets debossed "T" above and "13" below the bisect on one side and plain on the other side.

{ "type": "p", "children": [], "text": "Glycopyrrolate tablets USP 2 mg are white to off-white, round, flat faced bevel edged tablets debossed \"T\" above and \"13\" below the bisect on one side and plain on the other side." }

•  Available in bottles of 100 (NDC 70752-109-10).

{ "type": "p", "children": [], "text": "•  Available in bottles of 100 (NDC 70752-109-10)." }

•  Available in bottles of 1000 (NDC 70752-109-11).

{ "type": "p", "children": [], "text": "•  Available in bottles of 1000 (NDC 70752-109-11)." }

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

{ "type": "p", "children": [], "text": "Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children." }

Dispense in a tight container.

{ "type": "p", "children": [], "text": "Dispense in a tight container." }

Precipitation of Acute Glaucoma

{ "type": "p", "children": [], "text": "\nPrecipitation of Acute Glaucoma\n" }

Advise patients to discontinue Glycopyrrolate tablets and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients to discontinue Glycopyrrolate tablets and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [see Warnings and Precautions (5.1)]." }

Partial or Complete Mechanical Intestinal Obstruction

{ "type": "p", "children": [], "text": "\nPartial or Complete Mechanical Intestinal Obstruction\n" }

Advise patients to contact their healthcare provider if diarrhea occurs, especially in patients with ileostomy or colostomy [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients to contact their healthcare provider if diarrhea occurs, especially in patients with ileostomy or colostomy [see Warnings and Precautions (5.2)]." }

Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

{ "type": "p", "children": [], "text": "\nGastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility\n" }

Inform patients that Glycopyrrolate tablets may cause adverse reactions related to decreased gastrointestinal motility and report to their healthcare provider if they experience symptoms such as vomiting, early satiety, abdominal distention, and constipation [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients that Glycopyrrolate tablets may cause adverse reactions related to decreased gastrointestinal motility and report to their healthcare provider if they experience symptoms such as vomiting, early satiety, abdominal distention, and constipation [see Warnings and Precautions (5.3)]." }

Cognitive and Visual Adverse Reactions

{ "type": "p", "children": [], "text": "\nCognitive and Visual Adverse Reactions\n" }

Inform patients that Glycopyrrolate tablets may cause cognitive or visual impairment and not operate motor vehicles or other dangerous machinery or perform

{ "type": "p", "children": [], "text": "Inform patients that Glycopyrrolate tablets may cause cognitive or visual impairment and not operate motor vehicles or other dangerous machinery or perform" }

other hazardous tasks until they are reasonably certain that Glycopyrrolate tablets do not affect them adversely. Advise patients to discontinue Glycopyrrolate tablets immediately and contact their healthcare provider if symptoms develop (e.g., drowsiness or blurred vision) [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "other hazardous tasks until they are reasonably certain that Glycopyrrolate tablets do not affect them adversely. Advise patients to discontinue Glycopyrrolate tablets immediately and contact their healthcare provider if symptoms develop (e.g., drowsiness or blurred vision) [see Warnings and Precautions (5.4)]." }

Heat Prostration at High Environmental Temperatures

{ "type": "p", "children": [], "text": "\nHeat Prostration at High Environmental Temperatures\n" }

Inform patients that Glycopyrrolate tablets can reduce sweating, leading to the possibility of heat exhaustion or heat stroke. Advise patients to avoid exposure to hot or very warm environmental temperatures [see Warnings and Precautions (5.5)]

{ "type": "p", "children": [], "text": "Inform patients that Glycopyrrolate tablets can reduce sweating, leading to the possibility of heat exhaustion or heat stroke. Advise patients to avoid exposure to hot or very warm environmental temperatures [see Warnings and Precautions (5.5)]" }

Manufactured by:  Quagen Pharmaceuticals LLC West Caldwell, NJ 07006

{ "type": "p", "children": [], "text": "Manufactured by: \nQuagen Pharmaceuticals LLC\nWest Caldwell, NJ 07006" }

52008

{ "type": "p", "children": [], "text": "52008" }

Rev. 06/24

{ "type": "p", "children": [], "text": "Rev. 06/24" }