Sertraline hydrochloride oral solution is indicated for the treatment of the following [See Clinical Studies (14)]:

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The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.

For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 1: Recommended Daily Dosage of Sertraline Hydrochloride in Patients with MDD, OCD, PD, PTSD, and SAD</span> </caption> <col width="35%"/> <col width="31%"/> <col width="33%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Indication</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Starting Dose</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Therapeutic Range</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Adults</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">MDD</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">50 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" rowspan="3" valign="middle"> <p class="First">50-200 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">OCD</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">50 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">PD, PTSD, SAD</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">25 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Pediatric Patients</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">OCD (ages 6-12 years old)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">25 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="middle"> <p class="First">50-200 mg</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">OCD (ages 13-17 years old)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">50 mg</p> </td> </tr> </tbody> </table></div>

The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

Prior to initiating treatment with sertraline hydrochloride or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4)].

Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)]. The use of sertraline hydrochloride in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10-15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride. In addition, at least 14 days must elapse after stopping sertraline hydrochloride before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].

Adverse reactions may occur upon discontinuation of sertraline hydrochloride [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping sertraline hydrochloride abruptly whenever possible.

Sertraline hydrochloride oral solution must be diluted before use.

Instruct patients or caregivers to immediately take the dose after mixing.

Oral solution: a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

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Sertraline hydrochloride is contraindicated in patients:

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In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution is contraindicated in patients:

{ "type": "p", "children": [], "text": "In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution is contraindicated in patients:" }

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In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients</span> </caption> <col width="19%"/> <col width="81%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Age Range (years)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Increases Compared to Placebo</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">&lt;18</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">14 additional patients</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">18-24</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5 additional patients</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Decreases Compared to Placebo</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">25-64</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 fewer patient</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">≥65</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6 fewer patients</p> </td> </tr> </tbody> </table></div>

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing sertraline hydrochloride, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [See Contraindications (4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of sertraline hydrochloride with MAOIs is contraindicated. In addition, do not initiate sertraline hydrochloride in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking sertraline hydrochloride, discontinue sertraline hydrochloride before initiating treatment with the MAOI [See Contraindications (4), Drug Interactions (7.1)].

Monitor all patients taking sertraline hydrochloride for the emergence of serotonin syndrome. Discontinue treatment with sertraline hydrochloride and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of sertraline hydrochloride with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

Drugs that interfere with serotonin reuptake inhibition, including sertraline hydrochloride, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

In patients with bipolar disorder, treating a depressive episode with sertraline hydrochloride or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with sertraline hydrochloride. Prior to initiating treatment with sertraline hydrochloride, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration (2.6)].

Sertraline hydrochloride has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. Sertraline hydrochloride should be prescribed with caution in patients with a seizure disorder.

The pupillary dilation that occurs following use of many antidepressant drugs including sertraline hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including sertraline hydrochloride, in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including sertraline hydrochloride. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue sertraline hydrochloride and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [See Use in Specific Populations (8.5)].

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline hydrochloride. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish sertraline hydrochloride from benzodiazepines [See Drug Interactions (7.3)].

During post-marketing use of sertraline, cases of QTc prolongation and Torsade de Pointes (TdP) have been reported. Most reports were confounded by other risk factors. In a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects, there was a positive relationship between the length of the rate-adjusted QTc interval and serum sertraline concentration. Therefore, sertraline hydrochloride should be used with caution in patients with risk factors for QTc prolongation [See Drug Interactions (7.1), Clinical Pharmacology (12.2)].

Use of SSRIs, including sertraline hydrochloride, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of sertraline hydrochloride and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

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 are from randomized, double-blind, placebo-controlled trials of sertraline hydrochloride (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to sertraline hydrochloride for 8 to12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males.

The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline hydrochloride-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></span> </caption> <col width="66%"/> <col width="17%"/> <col width="16%"/> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Denominator used was for male patients only (n=1316 sertraline hydrochloride; n=973 placebo).</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Sertraline Hydrochloride</span> </p> <p> <span class="Bold">(N=3066)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=2293)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Cardiac disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Palpitations</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Eye disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Visual impairment</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Gastrointestinal disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Nausea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">26%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Diarrhea/Loose stools</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Dry mouth</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">14%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Dyspepsia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Constipation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Vomiting</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">General disorders and administration site conditions</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Fatigue</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Metabolism and nutrition disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Decreased appetite</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Nervous system disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Dizziness</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">12%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Somnolence</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Tremor</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Psychiatric disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Insomnia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">20%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">13%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Agitation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Libido decreased</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Reproductive system and breast disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Ejaculation failure<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Erectile dysfunction<a class="Sup" href="#footnote-2">†</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Ejaculation disorder<a class="Sup" href="#footnote-2">†</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Male sexual dysfunction<a class="Sup" href="#footnote-2">†</a> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Skin and subcutaneous tissue disorders</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">   Hyperhidrosis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3%</p> </td> </tr> </tbody> </table></div>

In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received sertraline hydrochloride discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline hydrochloride-treated patients:

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline hydrochloride-treated patients and twice placebo from pooled placebo-controlled trials. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Table 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from Sertraline Hydrochloride Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD</span> </caption> <col width="44%"/> <col width="30%"/> <col width="26%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Sertraline <br/>Hydrochloride</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Men only</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">(N=1316)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">(N=973)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Ejaculation failure</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Libido decreased</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Erectile dysfunction</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Ejaculation disorder</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">   Male sexual dysfunction</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Women only</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">(N=1750)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">(N=1320)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">   Libido decreased</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2%</p> </td> </tr> </tbody> </table></div>

In 281 pediatric patients treated with sertraline hydrochloride in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with sertraline hydrochloride were:

Cardiac disorders - tachycardia

Ear and labyrinth disorders - tinnitus

Endocrine disorders - hypothyroidism

Eye disorders - mydriasis, blurred vision

Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage

General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia

Hepatobiliary disorders - elevated liver enzymes

Immune system disorders - anaphylaxis

Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite

Musculoskeletal and connective tissue disorders - arthralgia, muscle spasms, tightness, or twitching

Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope

Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination

Renal and urinary disorders - hematuria

Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage

Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning

Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria

Vascular disorders - hemorrhage, hypertension, vasodilation

The following adverse reactions have been identified during postapproval use of sertraline hydrochloride. 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.

Bleeding or clotting disorders - increased coagulation times (altered platelet function)

Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [See Clinical Pharmacology (12.2)]

Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH

Eye disorders - blindness, optic neuritis, cataract

Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis

Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness

Immune system disorders - angioedema

Metabolism and nutrition disorders - hyponatremia, hyperglycemia

Musculoskeletal and connective tissue disorders - rhabdomyolysis, trismus

Nervous system disorders - serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis

Psychiatric disorders - psychosis, enuresis, paroniria

Renal and urinary disorders - acute renal failure

Respiratory, thoracic and mediastinal disorders - pulmonary hypertension, eosinophilic pneumonia, anosmia, hyposmia

Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)

Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

Table 5 includes clinically significant drug interactions with sertraline hydrochloride [See Clinical Pharmacology (12.3)].

Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="22%"/> <col width="78%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Monoamine Oxidase Inhibitors (MAOIs)</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[See <a href="#ID_707b8c08-1c86-4851-ab0d-673dc0dbf37a">Dosage and Administration (2.5)</a>, <a href="#ID_48B2BCC1-2FED-4BD2-B88F-E9FF4318E90F">Contraindications (4)</a>, <a href="#ID_bbb0db31-14ff-44ca-8dc6-fde54f5a584d">Warnings and Precautions (5.2)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Pimozide</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Concomitant use of pimozide and sertraline hydrochloride is contraindicated <span class="Italics">[See <a href="#ID_48B2BCC1-2FED-4BD2-B88F-E9FF4318E90F">Contraindications (4)</a>]</span>.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Other Serotonergic Drugs</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">The concomitant use of serotonergic drugs with sertraline hydrochloride increases the risk of serotonin syndrome.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of sertraline hydrochloride and/or concomitant serotonergic drugs <span class="Italics">[See <a href="#ID_bbb0db31-14ff-44ca-8dc6-fde54f5a584d">Warnings and Precautions (5.2)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">The concurrent use of an antiplatelet agent or anticoagulant with sertraline hydrochloride may potentiate the risk of bleeding.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio <span class="Italics">[See <a href="#ID_4cf97491-67ce-4243-82d1-0cea29ec7384">Warnings and Precautions (5.3)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">aspirin, clopidogrel, heparin, warfarin</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs Highly Bound to Plasma Protein</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Sertraline hydrochloride is highly bound to plasma protein. The concomitant use of sertraline hydrochloride with another drug that is highly bound to plasma protein may increase free concentrations of sertraline hydrochloride or other tightly-bound drugs in plasma <span class="Italics">[See <a href="#ID_D2BF8ED1-FBD3-456B-A93F-66FD79CD1350">Clinical Pharmacology (12.3)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">warfarin</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs Metabolized by CYP2D6</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Sertraline hydrochloride is a CYP2D6 inhibitor <span class="Italics">[See <a href="#ID_D2BF8ED1-FBD3-456B-A93F-66FD79CD1350">Clinical Pharmacology (12.3)</a>]</span>. The concomitant use of sertraline hydrochloride with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline hydrochloride use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride is discontinued.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Phenytoin</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Phenytoin is a narrow therapeutic index drug. Sertraline hydrochloride may increase phenytoin concentrations.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Monitor phenytoin levels when initiating or titrating sertraline hydrochloride. Reduce phenytoin dosage if needed.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">phenytoin, fosphenytoin</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs that Prolong the QTc Interval</span> </p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of other drugs which prolong the QTc interval <span class="Italics">[See <a href="#ID_921575fe-6e10-4e9e-becc-8198b6dc0543">Warnings and Precautions (5.10)</a>, <a href="#ID_200D0DD4-498D-48F7-B213-4820DB60E158">Clinical Pharmacology (12.2)</a>]</span>.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule" valign="middle"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Pimozide is contraindicated for use with sertraline. Avoid the concomitant use of drugs known to prolong the QTc interval.</p> </td> </tr> <tr> <td align="right" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).</p> </td> </tr> </tbody> </table></div>

Based on pharmacokinetic studies, no dosage adjustment of sertraline hydrochloride is necessary when used in combination with cimetidine. Additionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when sertraline hydrochloride is administered concomitantly [See Clinical Pharmacology (12.3)].

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline hydrochloride. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations].

Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data]. There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including sertraline hydrochloride, during the third trimester of pregnancy [See Clinical Considerations].

Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times the MRHD in rabbits on a mg/m2 basis in adolescents. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD [See Data].

The background risk of major birth defects and miscarriage for the indicated population are 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. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride.

Sertraline hydrochloride oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy.

A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Use of sertraline hydrochloride in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3)].

Exposure to SSRIs and SNRIs, including sertraline hydrochloride in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

When treating a pregnant woman with sertraline hydrochloride during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to sertraline hydrochloride in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [See Data].

Human Data

Third Trimester Exposure

Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [See Warnings and Precautions (5.2)].

Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997-2005 found a PPHN risk ratio of 2.4 (95% CI 1.2-4.3) associated with patient-reported maternal use of SSRIs “in early pregnancy” and a PPHN risk ratio of 3.6 (95% CI 1.2-8.3) associated with a combination of patient-reported maternal use of SSRIs “in early pregnancy” and an antenatal SSRI prescription “in later pregnancy”.

First Trimester Exposure

The weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline. A meta-analysis of studies suggest no increase in the risk of total malformations (summary odds ratio=1.01, 95% CI=0.88-1.17) or cardiac malformations (summary odds ratio=0.93, 95% CI=0.70-1.23) among offspring of women with first trimester exposure to sertraline. An increased risk of congenital cardiac defects, specifically septal defects, the most common type of congenital heart defect, was observed in some published epidemiologic studies with first trimester sertraline exposure; however, most of these studies were limited by the use of comparison populations that did not allow for the control of confounders such as the underlying depression and associated conditions and behaviors, which may be factors associated with increased risk of these malformations.

Animal Data

Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 3.1 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis in adolescents. There was no evidence of teratogenicity at any dose level. When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.4 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg (3.1 times the MRHD on a mg/m2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in stillborn pups and pup deaths during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (0.8 times the MRHD on a mg/m2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.4 times the MRHD on a mg/m2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown.

Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data]. There are no data on the effects of sertraline on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sertraline hydrochloride and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

In a published pooled analysis of 53 mother-infant pairs, exclusively human milk-fed infants had an average of 2% (range 0% to 15%) of the sertraline serum levels measured in their mothers. No adverse reactions were observed in these infants.

The safety and efficacy of sertraline hydrochloride have been established in the treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)]. Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients.

Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [See Boxed Warning, Warnings and Precautions (5.1)]. Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with an SSRI such as sertraline hydrochloride.

In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50-200 mg) outpatient trials for MDD (n=373), there was a difference in weight change between sertraline hydrochloride and placebo of roughly 1 kg, for both children (ages 6-11) and adolescents (ages 12-17), in both age groups representing a slight weight loss for the sertraline hydrochloride group compared to a slight gain for the placebo group. For children, about 7% of the sertraline hydrochloride-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for adolescents, about 2% of sertraline hydrochloride-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients.

A subset of patients who completed the randomized controlled trials in patients with MDD (sertraline hydrochloride n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. Those subjects who completed 34 weeks of sertraline hydrochloride treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. However, there are no studies that directly evaluate the long-term effects of sertraline hydrochloride on the growth, development, and maturation in pediatric patients.

Sertraline hydrochloride oral solution contains 12% alcohol.

A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females.

In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period. The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6-17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

Of the total number of patients in clinical studies of sertraline hydrochloride in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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 conservative, 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 drug therapy.

In 354 geriatric subjects treated with sertraline hydrochloride in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 3 [See Adverse Reactions (6.1)], except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients.

SNRIs and SSRIs, including sertraline hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [See Warnings and Precautions (5.8)].

The recommended dosage in patients with mild hepatic impairment (Child-Pugh score 5 or 6) is half the recommended dosage due to increased exposure in this patient population. The use of sertraline hydrochloride in patients with moderate (Child-Pugh score 7 to 10) or severe hepatic impairment (Child-Pugh score 10-15) is not recommended, because sertraline hydrochloride is extensively metabolized, and the effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied [See Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment [See Clinical Pharmacology (12.3)].

Sertraline hydrochloride oral solution contains sertraline, which is not a controlled substance.

In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.

The following have been reported with sertraline tablet overdosage:

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Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

{ "type": "p", "children": [], "text": "Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations." }

Sertraline hydrochloride oral solution contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula:

{ "type": "p", "children": [], "text": "Sertraline hydrochloride oral solution contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula:" }

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

{ "type": "p", "children": [], "text": "Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol." }

Sertraline hydrochloride oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.

{ "type": "p", "children": [], "text": "Sertraline hydrochloride oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber." }

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors. Sertraline does not inhibit monoamine oxidase.

In healthy subjects, the acute cognitive and psychomotor effects of alcohol were not potentiated by sertraline hydrochloride.

The effect of sertraline on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects. At 2-fold the maximum recommended daily dose (~3-fold the steady-state exposure for sertraline and N-desmethylsertraline), the largest mean ΔΔQTc was 10 ms with upper bound of two-sided 90% confidence interval of 12 ms. The length of the QTc interval was also positively correlated with serum concentrations of sertraline and N- desmethylsertraline concentrations. These concentration-based analyses, however, indicated a lesser effect on QTc at maximally observed concentration than in the primary analysis [See Warnings and Precautions (5), Adverse Reactions (6), Drug Interactions (7), Overdosage (10)].

Following oral once-daily sertraline hydrochloride dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing. Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the Cmax and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. The single dose bioavailability of sertraline hydrochloride tablets is approximately equal to an equivalent dose of sertraline hydrochloride oral solution. Administration with food causes a small increase in Cmax and AUC.

Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation. N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline. Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40-45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40-45% of the administered radioactivity was accounted for in feces, including 12-14% unchanged sertraline.

Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0-24-hour), Cmax and Cmin, with about a 5- to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14.

In vitro protein binding studies performed with radiolabeled 3H-sertraline showed that sertraline is highly bound to serum proteins (98%) in the range of 20 to 500 ng/mL. However, at up to 300 and 200 ng/mL concentrations, respectively, sertraline and N-desmethylsertraline did not alter the plasma protein binding of two other highly protein bound drugs, warfarin and propranolol.

Sertraline pharmacokinetics were evaluated in a group of 61 pediatric patients (29 aged 6-12 years, 32 aged 13-17 years) including both males (N=28) and females (N=33). Relative to the adults, pediatric patients aged 6-12 years and 13-17 years showed about 22% lower AUC (0-24 hr) and Cmax values when plasma concentration was adjusted for weight. The half-life was similar to that in adults, and no gender-associated differences were observed [See Dosage and Administration (2.1), Use in Specific Populations (8.4)].

Sertraline plasma clearance in a group of 16 (8 male, 8 female) elderly patients treated with 100 mg/day of sertraline hydrochloride for 14 days was approximately 40% lower than in a similarly studied group of younger (25 to 32 year old) individuals. Steady-state, therefore, was achieved after 2 to 3 weeks in older patients. The same study showed a decreased clearance of desmethylsertraline in older males, but not in older females [See Use in Specific Populations (8.5)].

In patients with chronic mild liver impairment (N=10: 8 patients with Child-Pugh scores of 5-6; and 2 patients with Child-Pugh scores of 7-8) who received 50 mg of sertraline hydrochloride per day for 21 days, sertraline clearance was reduced, resulting in approximately 3-fold greater exposure compared to age-matched volunteers with normal hepatic function (N=10). The exposure to desmethylsertraline was approximately 2-fold greater in patients with mild hepatic impairment compared to age-matched volunteers with normal hepatic function. There were no significant differences in plasma protein binding observed between the two groups. The effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied [See Dosage and Administration (2.4), Use in Specific Populations (8.6)].

Sertraline is extensively metabolized and excretion of unchanged drug in urine is a minor route of elimination. In volunteers with mild to moderate (CLcr=30-60 mL/min), moderate to severe (CLcr=10-29 mL/min) or severe (receiving hemodialysis) renal impairment (N=10 each group), the pharmacokinetics and protein binding of 200 mg sertraline per day maintained for 21 days were not altered compared to age-matched volunteers (N=12) with no renal impairment. Thus sertraline multiple dose pharmacokinetics appear to be unaffected by renal impairment [See Use in Specific Populations (8.7)].

In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline hydrochloride (once daily) co-administration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in ECG. The highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline hydrochloride. The effect on QTc interval and PK parameters at doses higher than 2 mg of pimozide are not known [See Drug Interactions (7.1)].

Many antidepressant drugs (e.g., SSRIs, including sertraline hydrochloride, and most tricyclic antidepressant drugs) inhibit the biochemical activity of the drug metabolizing isozyme CYP2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by CYP2D6. The drugs for which this potential interaction is of greatest concern are those metabolized primarily by CYP2D6 and that have a narrow therapeutic index (e.g., tricyclic antidepressant drugs and the Type 1C antiarrhythmics propafenone and flecainide). The extent to which this interaction is an important clinical problem depends on the extent of the inhibition of CYP2D6 by the antidepressant and the therapeutic index of the co-administered drug. There is variability among the drugs effective in the treatment of MDD in the extent of clinically important 2D6 inhibition, and in fact sertraline hydrochloride at lower doses has a less prominent inhibitory effect on 2D6 than some others in the class. Nevertheless, even sertraline hydrochloride has the potential for clinically important 2D6 inhibition [See Drug Interactions (7.1)].

Clinical trial data suggested that sertraline hydrochloride may increase phenytoin concentrations [See Drug Interactions (7.1)].

In a study assessing disposition of sertraline hydrochloride (100 mg) on the second of 8 days of cimetidine administration (800 mg daily), there were increases in sertraline hydrochloride mean AUC (50%), Cmax (24%) and half-life (26%) compared to the placebo group [See Drug Interactions (7.2)].

In a study comparing the disposition of intravenously administered diazepam before and after 21 days of dosing with either sertraline hydrochloride (50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the sertraline hydrochloride group compared to a 19% decrease relative to baseline for the placebo group (p<0.03). There was a 23% increase in Tmax for desmethyldiazepam in the sertraline hydrochloride group compared to a 20% decrease in the placebo group (p<0.03) [See Drug Interactions (7.2)].

In a placebo-controlled trial in normal volunteers, the administration of two doses of sertraline hydrochloride did not significantly alter steady-state lithium levels or the renal clearance of lithium [See Drug Interactions (7.2)].

In a placebo-controlled trial in normal volunteers, administration of sertraline hydrochloride for 22 days (including 200 mg/day for the final 13 days) caused a statistically significant 16% decrease from baseline in the clearance of tolbutamide following an intravenous 1000 mg dose. Sertraline hydrochloride administration did not noticeably change either the plasma protein binding or the apparent volume of distribution of tolbutamide, suggesting that the decreased clearance was due to a change in the metabolism of the drug [See Drug Interactions (7.2)].

Sertraline hydrochloride (100 mg) when administered to 10 healthy male subjects had no effect on the beta-adrenergic blocking ability of atenolol [See Drug Interactions (7.2)].

In a placebo-controlled trial in normal volunteers, administration of sertraline hydrochloride for 17 days (including 200 mg/day for the last 10 days) did not change serum digoxin levels or digoxin renal clearance [See Drug Interactions (7.2)].

In three separate in vivo interaction studies, sertraline hydrochloride was co-administered with CYP3A4 substrates, terfenadine, carbamazepine, or cisapride under steady-state conditions. The results of these studies indicated that sertraline hydrochloride did not increase plasma concentrations of terfenadine, carbamazepine, or cisapride. These data indicate that sertraline hydrochloride’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance. Results of the interaction study with cisapride indicate that sertraline hydrochloride 200 mg (once daily) induces the metabolism of cisapride (cisapride AUC and Cmax were reduced by about 35%) [See Drug Interactions (7.2)].

Preclinical studies have shown sertraline hydrochloride to induce hepatic microsomal enzymes. In clinical studies, sertraline hydrochloride was shown to induce hepatic enzymes minimally as determined by a small (5%) but statistically significant decrease in antipyrine half-life following administration of 200 mg of sertraline hydrochloride per day for 21 days. This small change in antipyrine half-life reflects a clinically insignificant change in hepatic metabolism.

Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis. There was a dose-related increase of liver adenomas in male mice receiving sertraline at 10-40 mg/kg (0.25-1.0 times the MRHD on a mg/m2 basis). No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg (2 times the MRHD on a mg/m2 basis); this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10-40 mg/kg (0.5-2.0 times the MRHD on a mg/m2 basis) compared to placebo controls, this effect was not clearly drug related.

Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays: bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes.

A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (3.1 times the maximum recommended human dose on a mg/m2 basis in adolescents).

The efficacy of sertraline hydrochloride as a treatment for MDD was established in two randomized, double-blind, placebo-controlled studies and one double-blind, randomized-withdrawal study following an open label study in adult (ages 18 to 65) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria for MDD (studies MDD-1 and MDD-2).

Overall, these studies demonstrated sertraline hydrochloride to be superior to placebo on the Hamilton Rating Scale for Depression (HAMD-17) and the Clinical Global Impression Severity (CGI-S) of Illness and Global Improvement (CGI-I) scores. Study MDD-2 was not readily interpretable regarding a dose response relationship for effectiveness.

A third study (Study MDD-3) involved adult outpatients meeting the DSM-III criteria for MDD who had responded by the end of an initial 8-week open treatment phase on sertraline hydrochloride 50-200 mg/day. These patients (n=295) were randomized to continuation on double-blind sertraline hydrochloride 50-200 mg/day or placebo for 44 weeks. A statistically significantly lower relapse rate was observed for patients taking sertraline hydrochloride compared to those on placebo: sertraline hydrochloride [n=11 (8%)] and placebo [n=31 (39%)]. The mean sertraline hydrochloride dose for completers was 70 mg/day.

Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.

The effectiveness of sertraline hydrochloride in the treatment of OCD was demonstrated in three multicenter placebo-controlled studies of adult (age 18-65) non-depressed outpatients (Studies OCD-1, OCD-2, and OCD-3). Patients in all three studies had moderate to severe OCD (DSM-III or DSM-III-R) with mean baseline ratings on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score ranging from 23 to 25.

Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

The effectiveness of sertraline hydrochloride was studied in the risk reduction of OCD relapse. In Study OCD-4, patients ranging in age from 18–79 meeting DSM-III-R criteria for OCD who had responded during a 52-week single-blind trial on sertraline hydrochloride 50-200 mg/day (n=224) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for analysis of discontinuation due to relapse or insufficient clinical response. Response during the single-blind phase was defined as a decrease in the Y-BOCS score of ≥ 25% compared to baseline and a CGI-I of 1 (very much improved), 2 (much improved) or 3 (minimally improved). Insufficient clinical response during the double-blind phase indicated a worsening of the patient’s condition that resulted in study discontinuation, as assessed by the investigator. Relapse during the double-blind phase was defined as the following conditions being met (on three consecutive visits for 1 and 2, and condition 3 being met at visit 3):

Patients receiving continued sertraline hydrochloride treatment experienced a statistically significantly lower rate of discontinuation due to relapse or insufficient clinical response over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

The effectiveness of sertraline hydrochloride for the treatment of OCD was demonstrated in a 12-week, multicenter, placebo-controlled, parallel group study in a pediatric outpatient population (ages 6-17) (Study OCD-5). Sertraline hydrochloride (N=92) was initiated at doses of either 25 mg/day (pediatric patients ages 6-12) or 50 mg/day (adolescents, ages 13-17), and then titrated at 3 and 4 day intervals (25 mg incremental dose for pediatric patients ages 6-12) or 1 week intervals (50 mg incremental dose adolescents ages 13-17) over the next four weeks to a maximum dose of 200 mg/day, as tolerated. The mean dose for completers was 178 mg/day. Dosing was once a day in the morning or evening. Patients in this study had moderate to severe OCD (DSM-III-R) with mean baseline ratings on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score of 22. Patients receiving sertraline hydrochloride experienced a mean reduction of approximately 7 units on the CY-BOCS total score which was statistically significantly greater than the 3 unit reduction for placebo patients (n=95). Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

The effectiveness of sertraline hydrochloride in the treatment of PD was demonstrated in three double-blind, placebo-controlled studies (Studies PD-1, PD-2, and PD-3) of adult outpatients who had a primary diagnosis of PD (DSM-III-R), with or without agoraphobia.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age, race, or gender.

In Study PD-4, patients meeting DSM-III-R criteria for PD who had responded during a 52-week open trial on sertraline hydrochloride 50-200 mg/day (n=183) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for discontinuation due to relapse or insufficient clinical response. Response during the open phase was defined as a CGI-I score of 1(very much improved) or 2 (much improved). Insufficient clinical response in the double-blind phase indicated a worsening of the patient’s condition that resulted in study discontinuation, as assessed by the investigator. Relapse during the double-blind phase was defined as the following conditions being met on three consecutive visits:

Patients receiving continued sertraline hydrochloride treatment experienced a statistically significantly lower rate of discontinuation due to relapse or insufficient clinical response over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

The effectiveness of sertraline hydrochloride in the treatment of PTSD was established in two multicenter placebo-controlled studies (Studies PSTD-1 and PSTD-2) of adult outpatients who met DSM-III-R criteria for PTSD. The mean duration of PTSD for these patients was 12 years (Studies PSTD-1 and PSTD-2 combined) and 44% of patients (169 of the 385 patients treated) had secondary depressive disorder.

Studies PSTD-1 and PSTD-2 were 12-week flexible dose studies. Sertraline hydrochloride was initiated at 25 mg/day for the first week, and titrated in weekly increments of 50 mg per day to a maximum dose of 200 mg/day on the basis of clinical response and tolerability. The mean sertraline hydrochloride dose for completers was 146 mg/day and 151 mg/day, respectively, for Studies PSTD-1 and PSTD-2. Study outcome was assessed by the Clinician-Administered PTSD Scale Part 2 (CAPS), which is a multi-item instrument that measures the three PTSD diagnostic symptom clusters of reexperiencing/intrusion, avoidance/numbing, and hyperarousal as well as the patient-rated Impact of Event Scale (IES), which measures intrusion and avoidance symptoms. Patients receiving sertraline hydrochloride (N=99 and N=94, respectively) showed statistically significant improvement compared to placebo (N=83 and N=92) on change from baseline to endpoint on the CAPS, IES, and on the Clinical Global Impressions (CGI-S) Severity of Illness and Global Improvement (CGI-I) scores.

In two additional placebo-controlled PTSD trials (Studies PSTD-3 and PSTD-4), the difference in response to treatment between patients receiving sertraline hydrochloride and patients receiving placebo was not statistically significant. One of these additional studies was conducted in patients similar to those recruited for Studies PSTD-1 and PSTD-2, while the second additional study was conducted in predominantly male veterans.

As PTSD is a more common disorder in women than men, the majority (76%) of patients in Studies PSTD-1 and PSTD-2 described above were women. Post hoc exploratory analyses revealed a statistically significant difference between sertraline hydrochloride and placebo on the CAPS, IES and CGI in women, regardless of baseline diagnosis of comorbid major depressive disorder, but essentially no effect in the relatively smaller number of men in these studies. The clinical significance of this apparent gender effect is unknown at this time. There was insufficient information to determine the effect of race or age on outcome.

In Study PSTD-5, patients meeting DSM-III-R criteria for PTSD who had responded during a 24-week open trial on sertraline hydrochloride 50-200 mg/day (n=96) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for relapse. Response during the open phase was defined as a CGI-I of 1 (very much improved) or 2 (much improved), and a decrease in the CAPS-2 score of > 30% compared to baseline. Relapse during the double-blind phase was defined as the following conditions being met on two consecutive visits:

Patients receiving continued sertraline hydrochloride treatment experienced statistically significantly lower relapse rates over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

The effectiveness of sertraline hydrochloride in the treatment of SAD (also known as social phobia) was established in two multicenter, randomized, placebo-controlled studies (Study SAD-1 and SAD-2) of adult outpatients who met DSM-IV criteria for SAD.

Study SAD-1 was a 12-week, flexible dose study comparing sertraline hydrochloride (50-200 mg/day), n=211, to placebo, n=204, in which sertraline hydrochloride was initiated at 25 mg/day for the first week, then titrated to the maximum tolerated dose in 50 mg increments biweekly. Study outcomes were assessed by the:

Sertraline hydrochloride was statistically significantly more effective than placebo as measured by the LSAS and the percentage of responders.

Study SAD-2 was a 20-week, flexible dose study that compared sertraline hydrochloride (50-200 mg/day), n=135, to placebo, n=69. Sertraline hydrochloride was titrated to the maximum tolerated dose in 50 mg increments every 3 weeks. Study outcome was assessed by the:

Sertraline hydrochloride was shown to be statistically significantly more effective than placebo as measured by the BSPS total score and fear, avoidance and physiologic factor scores, as well as the FQ-SPS total score, and to have statistically significantly more responders than placebo as defined by the CGI-I. Subgroup analyses did not suggest differences in treatment outcome on the basis of gender. There was insufficient information to determine the effect of race or age on outcome.

In Study SAD-3, patients meeting DSM-IV criteria for SAD who had responded while assigned to sertraline hydrochloride (CGI-I of 1 or 2) during a 20-week placebo-controlled trial on sertraline hydrochloride 50-200 mg/day were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 24 weeks of observation for relapse. Relapse was defined as ≥ 2 point increase in the Clinical Global Impression Severity of Illness (CGI-S) score compared to baseline or study discontinuation due to lack of efficacy. Patients receiving sertraline hydrochloride continuation treatment experienced a statistically significantly lower relapse rate during this 24-week period than patients randomized to placebo substitution.

The effectiveness of sertraline hydrochloride for the treatment of PMDD was established in two double-blind, parallel group, placebo-controlled flexible dose trials (Studies PMDD-1 and PMDD-2) conducted over 3 menstrual cycles in adult female patients. The effectiveness of sertraline hydrochloride for PMDD for more than 3 menstrual cycles has not been systematically evaluated in controlled trials.

Patients in Study PMDD-1 met DSM-III-R criteria for Late Luteal Phase Dysphoric Disorder (LLPDD), the clinical entity referred to as PMDD in DSM-IV. Patients in Study PMDD-2 met DSM-IV criteria for PMDD. Study PMDD-1 utilized continuous daily dosing throughout the study, while Study PMDD-2 utilized luteal phase dosing (intermittent dosing) for the 2 weeks prior to the onset of menses. The mean duration of PMDD symptoms was approximately 10.5 years in both studies. Patients taking oral contraceptives were excluded from these trials; therefore, the efficacy of sertraline hydrochloride in combination with oral contraceptives for the treatment of PMDD is unknown.

Efficacy was assessed with the Daily Record of Severity of Problems (DRSP), a patient-rated instrument that mirrors the diagnostic criteria for PMDD as identified in the DSM-IV, and includes assessments for mood, physical symptoms, and other symptoms. Other efficacy assessments included the Hamilton Rating Scale for Depression (HAMD-17), and the Clinical Global Impression Severity of Illness (CGI-S) and Improvement (CGI-I) scores.

There was insufficient information to determine the effect of race or age on outcome in these studies.

Sertraline Hydrochloride Oral Solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol

{ "type": "p", "children": [], "text": "Sertraline Hydrochloride Oral Solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol " }

NDC 59762-0067-1      Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

{ "type": "p", "children": [], "text": "NDC 59762-0067-1      Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks." }

Store sertraline hydrochloride oral solution at 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].

{ "type": "p", "children": [], "text": "Store sertraline hydrochloride oral solution at 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]." }

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

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

Suicidal Thoughts and Behaviors

{ "type": "p", "children": [], "text": "\nSuicidal Thoughts and Behaviors\n" }

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1)]." }

Important Administration Instructions for Oral Solution

{ "type": "p", "children": [], "text": "\nImportant Administration Instructions for Oral Solution\n" }

For patients prescribed sertraline hydrochloride oral solution, inform them that:

{ "type": "p", "children": [], "text": "\nFor patients prescribed sertraline hydrochloride oral solution, inform them that:\n" }

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

Disulfiram Contraindication for Sertraline Hydrochloride Oral Solution

{ "type": "p", "children": [], "text": "\nDisulfiram Contraindication for Sertraline Hydrochloride Oral Solution\n" }

Inform patients not to take disulfiram when taking sertraline hydrochloride oral solution. Concomitant use is contraindicated due the alcohol content of the oral solution [See Contraindication (4)].

{ "type": "p", "children": [], "text": "Inform patients not to take disulfiram when taking sertraline hydrochloride oral solution. Concomitant use is contraindicated due the alcohol content of the oral solution [See Contraindication (4)]." }

Serotonin Syndrome

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

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)]." }

Increased Risk of Bleeding

{ "type": "p", "children": [], "text": "\nIncreased Risk of Bleeding\n" }

Inform patients about the concomitant use of sertraline hydrochloride with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients about the concomitant use of sertraline hydrochloride with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3)]." }

Activation of Mania/Hypomania

{ "type": "p", "children": [], "text": "\nActivation of Mania/Hypomania \n" }

Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4)]." }

Discontinuation Syndrome

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

Advise patients not to abruptly discontinue sertraline hydrochloride and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride is discontinued [See Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients not to abruptly discontinue sertraline hydrochloride and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride is discontinued [See Warnings and Precautions (5.5)]." }

Sexual Dysfunction

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

Advise patients that use of sertraline hydrochloride may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11)].

{ "type": "p", "children": [], "text": "Advise patients that use of sertraline hydrochloride may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11)]." }

Allergic Reactions

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

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2)]." }

Pregnancy

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

Inform pregnant women that sertraline hydrochloride may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride during pregnancy.

{ "type": "p", "children": [], "text": "Inform pregnant women that sertraline hydrochloride may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride during pregnancy." }

GREENSTONE® BRANDDistributed by: Greenstone LLC Morgantown, WV 26505 U.S.A.

{ "type": "p", "children": [], "text": "GREENSTONE® BRANDDistributed by:\nGreenstone LLC\nMorgantown, WV 26505 U.S.A." }

© 2024 Viatris Inc.

{ "type": "p", "children": [], "text": "© 2024 Viatris Inc." }

The brands listed are trademarks of their respective owners.

{ "type": "p", "children": [], "text": "The brands listed are trademarks of their respective owners." }

GST:SERT:R1

{ "type": "p", "children": [], "text": "GST:SERT:R1" }

<div class="scrollingtable"><table width="100%"> <col width="21%"/> <col width="12%"/> <col width="7%"/> <col width="2%"/> <col width="5%"/> <col width="3%"/> <col width="13%"/> <col width="4%"/> <col width="33%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="9" valign="top"> <p class="First"> <span class="Bold">Sertraline Hydrochloride</span> </p> <p> <span class="Bold"> </span> </p> <p> <span class="Bold">Oral Solution</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about sertraline hydrochloride oral solution?</span> </p> <p> <span class="Bold">Sertraline hydrochloride oral solution and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.</span> </p> <dl> <dt>1.</dt> <dd> <span class="Bold">Suicidal thoughts or actions: </span> </dd> <dt>•</dt> <dd> <span class="Bold">Sertraline hydrochloride oral solution and other antidepressant medicines may increase suicidal thoughts or actions</span> in some people 24 years of age and younger, especially within the <span class="Bold">first few months of treatment or when the dose is changed.</span> </dd> <dt>•</dt> <dd>Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.</dd> <dt>•</dt> <dd>Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.<dl> <dt>o</dt> <dd>Pay particular attention to such changes when sertraline hydrochloride oral solution is started or when the dose is changed.</dd> <dt>o</dt> <dd>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. </dd> </dl> </dd> </dl> <p> <span class="Bold">Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:</span> </p> </td> </tr> <tr> <td class="Lrule" colspan="6" valign="top"> <dl> <dt>o</dt> <dd>attempts to commit suicide</dd> <dt>o</dt> <dd>acting aggressive or violent</dd> <dt>o</dt> <dd>new or worse depression</dd> <dt>o</dt> <dd>feeling agitated, restless, angry or irritable</dd> <dt>o</dt> <dd>an increase in activity or talking more than <br/>what is normal for you</dd> </dl> </td><td class="Rrule" colspan="3" valign="top"> <dl> <dt>o</dt> <dd>acting on dangerous impulses</dd> <dt>o</dt> <dd>thoughts about suicide or dying</dd> <dt>o</dt> <dd>new or worse anxiety or panic attacks</dd> <dt>o</dt> <dd>trouble sleeping</dd> <dt>o</dt> <dd>other unusual changes in behavior or mood</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <dl> <dt>2.</dt> <dd> <span class="Bold">Serotonin Syndrome. </span>This condition can be life-threatening and symptoms may include:</dd> </dl> </td> </tr> <tr> <td class="Lrule" colspan="6" valign="top"> <dl> <dt>•</dt> <dd>agitation, hallucinations, coma, or other changes in mental status</dd> <dt>•</dt> <dd>racing heartbeat, high or low blood pressure</dd> <dt>•</dt> <dd>coordination problems or muscle twitching (overactive reflexes)</dd> </dl> </td><td class="Rrule" colspan="3" valign="top"> <dl> <dt>•</dt> <dd>nausea, vomiting, or diarrhea</dd> <dt>•</dt> <dd>sweating or fever</dd> <dt>•</dt> <dd>muscle rigidity</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <dl> <dt>3.</dt> <dd> <span class="Bold">Increased chance of bleeding: S</span>ertraline hydrochloride oral solution and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin<span class="Sup">®</span>, Jantoven<span class="Sup">®</span>), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.</dd> <dt>4.</dt> <dd> <span class="Bold">Manic episodes. </span>Symptoms may include:<span class="Bold"></span> </dd> </dl> </td> </tr> <tr> <td class="Lrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>greatly increased energy</dd> <dt>•</dt> <dd>racing thoughts</dd> <dt>•</dt> <dd>unusually grand ideas</dd> </dl> </td><td colspan="5" valign="top"> <dl> <dt>•</dt> <dd>severe trouble sleeping</dd> <dt>•</dt> <dd>reckless behavior</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>excessive happiness or irritability</dd> <dt>•</dt> <dd>talking more or faster than usual</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <dl> <dt>5.</dt> <dd> <span class="Bold">Seizures or convulsions.</span> </dd> <dt>6.</dt> <dd> <span class="Bold">Glaucoma (angle-closure glaucoma).</span> Many antidepressant medicines including sertraline hydrochloride oral solution may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.</dd> <dt>7.</dt> <dd> <span class="Bold">Changes in appetite or weight.</span> Children and adolescents should have height and weight monitored during treatment.</dd> <dt>8.</dt> <dd> <span class="Bold">Low salt (sodium) levels in the blood.</span> Elderly people may be at greater risk for this. Symptoms may include: </dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"> <dl> <dt>•</dt> <dd>headache</dd> </dl> </td><td colspan="4" valign="top"> <dl> <dt>•</dt> <dd>weakness or feeling unsteady</dd> </dl> </td><td class="Rrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd>confusion, problems concentrating or thinking, or memory problems</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <dl> <dt>9.</dt> <dd> <span class="Bold">Sexual problems (dysfunction). </span>Taking selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride oral solution, may cause sexual problems.<span class="Bold"></span> </dd> </dl> <p class="First">Symptoms in males may include:</p> <dl> <dt>•</dt> <dd>Delayed ejaculation or inability to have an ejaculation</dd> <dt>•</dt> <dd>Decreased sex drive</dd> <dt>•</dt> <dd>Problems getting or keeping an erection</dd> </dl> <p>Symptoms in females may include:</p> <dl> <dt>•</dt> <dd>Decreased sex drive</dd> <dt>•</dt> <dd>Delayed orgasm or inability to have an orgasm</dd> </dl> <p>Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydrochloride oral solution. There may be treatments your healthcare provider can suggest.</p> <p> <span class="Bold">Do not stop sertraline hydrochloride oral solution without first talking to your healthcare provider.</span> Stopping sertraline hydrochloride oral solution too quickly may cause serious symptoms including: </p> <dl> <dt>•</dt> <dd>anxiety, irritability, high or low mood, feeling restless or changes in sleep habits</dd> <dt>•</dt> <dd>headache, sweating, nausea, dizziness</dd> <dt>•</dt> <dd>electric shock-like sensations, shaking, confusion</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What is sertraline hydrochloride oral solution?</span> </p> <p> </p> <p>Sertraline hydrochloride oral solution is a prescription medicine used to treat: </p> </td> </tr> <tr> <td class="Lrule" colspan="6" valign="top"> <dl> <dt>•</dt> <dd>Major Depressive Disorder (MDD)</dd> <dt>•</dt> <dd>Panic Disorder</dd> <dt>•</dt> <dd>Social Anxiety Disorder</dd> </dl> </td><td class="Rrule" colspan="3" valign="top"> <dl> <dt>•</dt> <dd>Obsessive Compulsive Disorder (OCD)</dd> <dt>•</dt> <dd>Posttraumatic Stress Disorder (PTSD)</dd> <dt>•</dt> <dd>Premenstrual Dysphoric Disorder (PMDD)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First">It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.</p> <p>Sertraline hydrochloride oral solution is safe and effective in treating children with OCD age 6 to 17 years.</p> <p>It is not known if sertraline hydrochloride oral solution is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.</p> <p>Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride oral solution treatment.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">Who should not take sertraline hydrochloride oral solution? </span> </p> <p> <span class="Bold">Do not take sertraline hydrochloride oral solution if you:</span> </p> <dl> <dt>•</dt> <dd>take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.</dd> <dt>•</dt> <dd>have taken an MAOI within 2 weeks of stopping sertraline hydrochloride oral solution unless directed to do so by your healthcare provider.</dd> <dt>•</dt> <dd>have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.</dd> <dt>•</dt> <dd>take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).</dd> <dt>•</dt> <dd>take the antipsychotic medicine pimozide (Orap<span class="Sup">®</span>) because this can cause serious heart problems. </dd> <dt>•</dt> <dd>are allergic to sertraline or any of the ingredients in sertraline hydrochloride oral solution. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride oral solution.</dd> <dt>•</dt> <dd>take Antabuse<span class="Sup">®</span> (disulfiram) (if you are taking the liquid form of sertraline hydrochloride) due to the alcohol content.</dd> </dl> <p> <span class="Bold">People who take sertraline hydrochloride oral solution close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms: </span> </p> </td> </tr> <tr> <td class="Botrule Lrule" colspan="3" valign="top"> <dl> <dt>o</dt> <dd>high fever</dd> <dt>o</dt> <dd>rapid changes in heart rate or blood pressure</dd> </dl> </td><td class="Botrule" colspan="5" valign="top"> <dl> <dt>o</dt> <dd>uncontrolled muscle spasms</dd> <dt>o</dt> <dd>confusion</dd> </dl> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>o</dt> <dd>stiff muscles</dd> <dt>o</dt> <dd>loss of consciousness (pass out)</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule Toprule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What should I tell my healthcare provider before taking sertraline hydrochloride oral solution? </span> </p> <p> <span class="Bold">Before starting sertraline hydrochloride oral solution, tell your healthcare provider:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">if you have:</span> </dd> </dl> </td> </tr> <tr> <td class="Lrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>liver problems</dd> <dt>o</dt> <dd>heart problems</dd> <dt>o</dt> <dd>bipolar disorder or mania</dd> </dl> </td><td colspan="6" valign="top"> <dl> <dt>o</dt> <dd>kidney problems</dd> <dt>o</dt> <dd>or have had seizures or convulsions</dd> <dt>o</dt> <dd>low sodium levels in your blood</dd> </dl> </td><td class="Rrule" valign="top"> <dl> <dt>o</dt> <dd>a history of a stroke</dd> <dt>o</dt> <dd>high blood pressure</dd> <dt>o</dt> <dd>or have had bleeding problems</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">are pregnant or plan to become pregnant.</span> Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride oral solution during pregnancy.<dl> <dt>o</dt> <dd>There is a pregnancy registry for females who are exposed to sertraline hydrochloride during pregnancy. The purpose of the registry is to collect information about the health of females exposed to sertraline hydrochloride and their baby. If you or your child become pregnant during treatment with sertraline hydrochloride, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.</dd> </dl> </dd> <dt>•</dt> <dd> <span class="Bold">are breastfeeding or plan to breastfeed.</span> A small amount of sertraline hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride oral solution. </dd> </dl> <p class="First"> <span class="Bold">Tell your healthcare provider about all the medicines that you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. </p> <p> <span class="Bold">Especially tell your healthcare provider if you or your child take:</span> </p> <dl> <dt>•</dt> <dd>medicines used to treat migraine headaches called triptans</dd> <dt>•</dt> <dd>tricyclic antidepressants</dd> <dt>•</dt> <dd>lithium</dd> <dt>•</dt> <dd>tramadol, fentanyl, meperidine, methadone, or other opioids</dd> <dt>•</dt> <dd>tryptophan</dd> <dt>•</dt> <dd>buspirone</dd> <dt>•</dt> <dd>amphetamines</dd> <dt>•</dt> <dd>phenytoin</dd> <dt>•</dt> <dd>St. John’s Wort</dd> <dt>•</dt> <dd>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants</dd> <dt>•</dt> <dd>diuretics</dd> <dt>•</dt> <dd>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)</dd> </dl> <p>Sertraline hydrochloride oral solution and some medicines may interact with each other, may not work as well, or may cause serious side effects.</p> <p> </p> <p>Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride oral solution with your other medicines. <span class="Bold">Do not</span> start or stop any medicine while taking sertraline hydrochloride oral solution without talking to your healthcare provider first.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">How should I take sertraline hydrochloride oral solution?</span> </p> <dl> <dt>•</dt> <dd>Take sertraline hydrochloride oral solution exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride oral solution until it is the right dose for you.</dd> <dt>•</dt> <dd>Sertraline hydrochloride oral solution may look cloudy or hazy after mixing, this is normal.</dd> <dt>•</dt> <dd>Sertraline hydrochloride oral solution must be diluted before use:<dl> <dt>o</dt> <dd> <span class="Bold">Do not</span> mix sertraline hydrochloride oral solution until you are ready to take it.</dd> <dt>o</dt> <dd>When diluting sertraline hydrochloride oral solution, use <span class="Bold">only</span> water, ginger ale, lemon/lime soda, lemonade, or orange juice.</dd> <dt>o</dt> <dd>The oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or pharmacist about the best way to measure your medicine.</dd> </dl> </dd> <dt>•</dt> <dd>If you miss a dose of sertraline hydrochloride oral solution, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. <span class="Bold">Do not</span> take two doses of sertraline hydrochloride oral solution at the same time.</dd> </dl> <p> <span class="Bold">If you take too much sertraline hydrochloride oral solution, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What should I avoid while taking sertraline hydrochloride oral solution?</span> </p> <p>Sertraline hydrochloride oral solution can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride oral solution affects you. <span class="Bold">Do not</span> drink alcohol while you take sertraline hydrochloride oral solution.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of sertraline hydrochloride oral solution?</span> </p> <p>Sertraline hydrochloride oral solution may cause serious side effects, including:</p> <dl> <dt>•</dt> <dd> <span class="Bold">See “What is the most important information I should know about sertraline hydrochloride oral solution?”</span> </dd> </dl> <p> <span class="Bold">The most common side effects in adults who take sertraline hydrochloride oral solution include: </span> </p> </td> </tr> <tr> <td class="Lrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd>nausea, loss of appetite, diarrhea, or indigestion</dd> <dt>•</dt> <dd>increased sweating</dd> <dt>•</dt> <dd>tremor or shaking</dd> <dt>•</dt> <dd>agitation</dd> </dl> </td><td class="Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd>change in sleep habits including increased sleepiness or insomnia</dd> <dt>•</dt> <dd>sexual problems including decreased libido and ejaculation failure</dd> <dt>•</dt> <dd>feeling tired or fatigued</dd> <dt>•</dt> <dd>anxiety</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">The most common side effects in children and adolescents who take sertraline hydrochloride oral solution include</span> abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride oral solution.</p> <p>Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride oral solution. For more information, ask your healthcare provider or pharmacist. </p> <p>Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">How should I store sertraline hydrochloride oral solution? </span> </p> <dl> <dt>•</dt> <dd>Store sertraline hydrochloride oral solution at room temperature, 68°F to 77°F (20°C to 25°C).</dd> <dt>•</dt> <dd>Keep sertraline hydrochloride oral solution bottle closed tightly.</dd> </dl> <p> <span class="Bold">Keep sertraline hydrochloride oral solution and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="9" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of sertraline hydrochloride oral solution</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride oral solution for a condition for which it was not prescribed. Do not give sertraline hydrochloride oral solution to other people, even if they have the same condition. It may harm them.</p> <p>This Medication Guide summarizes the most important information about sertraline hydrochloride oral solution. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride oral solution that is written for healthcare professionals. </p> <p>For more information about sertraline hydrochloride oral solution, call 1-877-446-3679 (1-877-4-INFO-RX).</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="9" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in sertraline hydrochloride oral solution?</span> </p> <p> <span class="Bold"> </span> </p> <p> <span class="Bold">Active ingredient:</span> sertraline hydrochloride</p> <p> <span class="Bold"> </span> </p> <p> <span class="Bold">Inactive ingredients: </span> </p> <p> <span class="Bold">Oral solution:</span> glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)</p> <p> </p> <p>GREENSTONE<span class="Sup">®</span> BRAND</p> <p>Distributed by:<br/> <span class="Bold">Greenstone LLC</span> <br/>Morgantown, WV 26505 U.S.A.</p> <p>© 2024 Viatris Inc.</p> <p>The brands listed are trademarks of their respective owners.</p> <p>GST:MG:SERT:R1</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"21%\"/>\n<col width=\"12%\"/>\n<col width=\"7%\"/>\n<col width=\"2%\"/>\n<col width=\"5%\"/>\n<col width=\"3%\"/>\n<col width=\"13%\"/>\n<col width=\"4%\"/>\n<col width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Sertraline Hydrochloride</span>\n</p>\n<p>\n<span class=\"Bold\"> </span>\n</p>\n<p>\n<span class=\"Bold\">Oral Solution</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about sertraline hydrochloride oral solution?</span>\n</p>\n<p>\n<span class=\"Bold\">Sertraline hydrochloride oral solution and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>\n<span class=\"Bold\">Suicidal thoughts or actions: </span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Sertraline hydrochloride oral solution and other antidepressant medicines may increase suicidal thoughts or actions</span> in some people 24 years of age and younger, especially within the <span class=\"Bold\">first few months of treatment or when the dose is changed.</span>\n</dd>\n<dt>•</dt>\n<dd>Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.</dd>\n<dt>•</dt>\n<dd>Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.<dl>\n<dt>o</dt>\n<dd>Pay particular attention to such changes when sertraline hydrochloride oral solution is started or when the dose is changed.</dd>\n<dt>o</dt>\n<dd>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. </dd>\n</dl>\n</dd>\n</dl>\n<p>\n<span class=\"Bold\">Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"6\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>attempts to commit suicide</dd>\n<dt>o</dt>\n<dd>acting aggressive or violent</dd>\n<dt>o</dt>\n<dd>new or worse depression</dd>\n<dt>o</dt>\n<dd>feeling agitated, restless, angry or irritable</dd>\n<dt>o</dt>\n<dd>an increase in activity or talking more than <br/>what is normal for you</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>acting on dangerous impulses</dd>\n<dt>o</dt>\n<dd>thoughts about suicide or dying</dd>\n<dt>o</dt>\n<dd>new or worse anxiety or panic attacks</dd>\n<dt>o</dt>\n<dd>trouble sleeping</dd>\n<dt>o</dt>\n<dd>other unusual changes in behavior or mood</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<dl>\n<dt>2.</dt>\n<dd>\n<span class=\"Bold\">Serotonin Syndrome. </span>This condition can be life-threatening and symptoms may include:</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"6\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>agitation, hallucinations, coma, or other changes in mental status</dd>\n<dt>•</dt>\n<dd>racing heartbeat, high or low blood pressure</dd>\n<dt>•</dt>\n<dd>coordination problems or muscle twitching (overactive reflexes)</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>nausea, vomiting, or diarrhea</dd>\n<dt>•</dt>\n<dd>sweating or fever</dd>\n<dt>•</dt>\n<dd>muscle rigidity</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<dl>\n<dt>3.</dt>\n<dd>\n<span class=\"Bold\">Increased chance of bleeding: S</span>ertraline hydrochloride oral solution and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin<span class=\"Sup\">®</span>, Jantoven<span class=\"Sup\">®</span>), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.</dd>\n<dt>4.</dt>\n<dd>\n<span class=\"Bold\">Manic episodes. </span>Symptoms may include:<span class=\"Bold\"></span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>greatly increased energy</dd>\n<dt>•</dt>\n<dd>racing thoughts</dd>\n<dt>•</dt>\n<dd>unusually grand ideas</dd>\n</dl>\n</td><td colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>severe trouble sleeping</dd>\n<dt>•</dt>\n<dd>reckless behavior</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>excessive happiness or irritability</dd>\n<dt>•</dt>\n<dd>talking more or faster than usual</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<dl>\n<dt>5.</dt>\n<dd>\n<span class=\"Bold\">Seizures or convulsions.</span>\n</dd>\n<dt>6.</dt>\n<dd>\n<span class=\"Bold\">Glaucoma (angle-closure glaucoma).</span> Many antidepressant medicines including sertraline hydrochloride oral solution may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.</dd>\n<dt>7.</dt>\n<dd>\n<span class=\"Bold\">Changes in appetite or weight.</span> Children and adolescents should have height and weight monitored during treatment.</dd>\n<dt>8.</dt>\n<dd>\n<span class=\"Bold\">Low salt (sodium) levels in the blood.</span> Elderly people may be at greater risk for this. Symptoms may include: </dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>headache</dd>\n</dl>\n</td><td colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>weakness or feeling unsteady</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>confusion, problems concentrating or thinking, or memory problems</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<dl>\n<dt>9.</dt>\n<dd>\n<span class=\"Bold\">Sexual problems (dysfunction). </span>Taking selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride oral solution, may cause sexual problems.<span class=\"Bold\"></span>\n</dd>\n</dl>\n<p class=\"First\">Symptoms in males may include:</p>\n<dl>\n<dt>•</dt>\n<dd>Delayed ejaculation or inability to have an ejaculation</dd>\n<dt>•</dt>\n<dd>Decreased sex drive</dd>\n<dt>•</dt>\n<dd>Problems getting or keeping an erection</dd>\n</dl>\n<p>Symptoms in females may include:</p>\n<dl>\n<dt>•</dt>\n<dd>Decreased sex drive</dd>\n<dt>•</dt>\n<dd>Delayed orgasm or inability to have an orgasm</dd>\n</dl>\n<p>Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydrochloride oral solution. There may be treatments your healthcare provider can suggest.</p>\n<p>\n<span class=\"Bold\">Do not stop sertraline hydrochloride oral solution without first talking to your healthcare provider.</span> Stopping sertraline hydrochloride oral solution too quickly may cause serious symptoms including: </p>\n<dl>\n<dt>•</dt>\n<dd>anxiety, irritability, high or low mood, feeling restless or changes in sleep habits</dd>\n<dt>•</dt>\n<dd>headache, sweating, nausea, dizziness</dd>\n<dt>•</dt>\n<dd>electric shock-like sensations, shaking, confusion</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is sertraline hydrochloride oral solution?</span>\n</p>\n<p> </p>\n<p>Sertraline hydrochloride oral solution is a prescription medicine used to treat: </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"6\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Major Depressive Disorder (MDD)</dd>\n<dt>•</dt>\n<dd>Panic Disorder</dd>\n<dt>•</dt>\n<dd>Social Anxiety Disorder</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Obsessive Compulsive Disorder (OCD)</dd>\n<dt>•</dt>\n<dd>Posttraumatic Stress Disorder (PTSD)</dd>\n<dt>•</dt>\n<dd>Premenstrual Dysphoric Disorder (PMDD)</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.</p>\n<p>Sertraline hydrochloride oral solution is safe and effective in treating children with OCD age 6 to 17 years.</p>\n<p>It is not known if sertraline hydrochloride oral solution is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.</p>\n<p>Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride oral solution treatment.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not take sertraline hydrochloride oral solution? </span>\n</p>\n<p>\n<span class=\"Bold\">Do not take sertraline hydrochloride oral solution if you:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.</dd>\n<dt>•</dt>\n<dd>have taken an MAOI within 2 weeks of stopping sertraline hydrochloride oral solution unless directed to do so by your healthcare provider.</dd>\n<dt>•</dt>\n<dd>have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.</dd>\n<dt>•</dt>\n<dd>take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).</dd>\n<dt>•</dt>\n<dd>take the antipsychotic medicine pimozide (Orap<span class=\"Sup\">®</span>) because this can cause serious heart problems. </dd>\n<dt>•</dt>\n<dd>are allergic to sertraline or any of the ingredients in sertraline hydrochloride oral solution. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride oral solution.</dd>\n<dt>•</dt>\n<dd>take Antabuse<span class=\"Sup\">®</span> (disulfiram) (if you are taking the liquid form of sertraline hydrochloride) due to the alcohol content.</dd>\n</dl>\n<p>\n<span class=\"Bold\">People who take sertraline hydrochloride oral solution close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms: </span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>high fever</dd>\n<dt>o</dt>\n<dd>rapid changes in heart rate or blood pressure</dd>\n</dl>\n</td><td class=\"Botrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>uncontrolled muscle spasms</dd>\n<dt>o</dt>\n<dd>confusion</dd>\n</dl>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>stiff muscles</dd>\n<dt>o</dt>\n<dd>loss of consciousness (pass out)</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I tell my healthcare provider before taking sertraline hydrochloride oral solution? </span>\n</p>\n<p>\n<span class=\"Bold\">Before starting sertraline hydrochloride oral solution, tell your healthcare provider:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">if you have:</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>liver problems</dd>\n<dt>o</dt>\n<dd>heart problems</dd>\n<dt>o</dt>\n<dd>bipolar disorder or mania</dd>\n</dl>\n</td><td colspan=\"6\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>kidney problems</dd>\n<dt>o</dt>\n<dd>or have had seizures or convulsions</dd>\n<dt>o</dt>\n<dd>low sodium levels in your blood</dd>\n</dl>\n</td><td class=\"Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>a history of a stroke</dd>\n<dt>o</dt>\n<dd>high blood pressure</dd>\n<dt>o</dt>\n<dd>or have had bleeding problems</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">are pregnant or plan to become pregnant.</span> Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride oral solution during pregnancy.<dl>\n<dt>o</dt>\n<dd>There is a pregnancy registry for females who are exposed to sertraline hydrochloride during pregnancy. The purpose of the registry is to collect information about the health of females exposed to sertraline hydrochloride and their baby. If you or your child become pregnant during treatment with sertraline hydrochloride, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">are breastfeeding or plan to breastfeed.</span> A small amount of sertraline hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride oral solution. </dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">Tell your healthcare provider about all the medicines that you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. </p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you or your child take:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>medicines used to treat migraine headaches called triptans</dd>\n<dt>•</dt>\n<dd>tricyclic antidepressants</dd>\n<dt>•</dt>\n<dd>lithium</dd>\n<dt>•</dt>\n<dd>tramadol, fentanyl, meperidine, methadone, or other opioids</dd>\n<dt>•</dt>\n<dd>tryptophan</dd>\n<dt>•</dt>\n<dd>buspirone</dd>\n<dt>•</dt>\n<dd>amphetamines</dd>\n<dt>•</dt>\n<dd>phenytoin</dd>\n<dt>•</dt>\n<dd>St. John’s Wort</dd>\n<dt>•</dt>\n<dd>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants</dd>\n<dt>•</dt>\n<dd>diuretics</dd>\n<dt>•</dt>\n<dd>medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)</dd>\n</dl>\n<p>Sertraline hydrochloride oral solution and some medicines may interact with each other, may not work as well, or may cause serious side effects.</p>\n<p> </p>\n<p>Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride oral solution with your other medicines. <span class=\"Bold\">Do not</span> start or stop any medicine while taking sertraline hydrochloride oral solution without talking to your healthcare provider first.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take sertraline hydrochloride oral solution?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Take sertraline hydrochloride oral solution exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride oral solution until it is the right dose for you.</dd>\n<dt>•</dt>\n<dd>Sertraline hydrochloride oral solution may look cloudy or hazy after mixing, this is normal.</dd>\n<dt>•</dt>\n<dd>Sertraline hydrochloride oral solution must be diluted before use:<dl>\n<dt>o</dt>\n<dd>\n<span class=\"Bold\">Do not</span> mix sertraline hydrochloride oral solution until you are ready to take it.</dd>\n<dt>o</dt>\n<dd>When diluting sertraline hydrochloride oral solution, use <span class=\"Bold\">only</span> water, ginger ale, lemon/lime soda, lemonade, or orange juice.</dd>\n<dt>o</dt>\n<dd>The oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or pharmacist about the best way to measure your medicine.</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>If you miss a dose of sertraline hydrochloride oral solution, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. <span class=\"Bold\">Do not</span> take two doses of sertraline hydrochloride oral solution at the same time.</dd>\n</dl>\n<p>\n<span class=\"Bold\">If you take too much sertraline hydrochloride oral solution, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid while taking sertraline hydrochloride oral solution?</span>\n</p>\n<p>Sertraline hydrochloride oral solution can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride oral solution affects you. <span class=\"Bold\">Do not</span> drink alcohol while you take sertraline hydrochloride oral solution.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of sertraline hydrochloride oral solution?</span>\n</p>\n<p>Sertraline hydrochloride oral solution may cause serious side effects, including:</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">See “What is the most important information I should know about sertraline hydrochloride oral solution?”</span>\n</dd>\n</dl>\n<p>\n<span class=\"Bold\">The most common side effects in adults who take sertraline hydrochloride oral solution include: </span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>nausea, loss of appetite, diarrhea, or indigestion</dd>\n<dt>•</dt>\n<dd>increased sweating</dd>\n<dt>•</dt>\n<dd>tremor or shaking</dd>\n<dt>•</dt>\n<dd>agitation</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>change in sleep habits including increased sleepiness or insomnia</dd>\n<dt>•</dt>\n<dd>sexual problems including decreased libido and ejaculation failure</dd>\n<dt>•</dt>\n<dd>feeling tired or fatigued</dd>\n<dt>•</dt>\n<dd>anxiety</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">The most common side effects in children and adolescents who take sertraline hydrochloride oral solution include</span> abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride oral solution.</p>\n<p>Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride oral solution. For more information, ask your healthcare provider or pharmacist. </p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store sertraline hydrochloride oral solution? </span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store sertraline hydrochloride oral solution at room temperature, 68°F to 77°F (20°C to 25°C).</dd>\n<dt>•</dt>\n<dd>Keep sertraline hydrochloride oral solution bottle closed tightly.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Keep sertraline hydrochloride oral solution and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of sertraline hydrochloride oral solution</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride oral solution for a condition for which it was not prescribed. Do not give sertraline hydrochloride oral solution to other people, even if they have the same condition. It may harm them.</p>\n<p>This Medication Guide summarizes the most important information about sertraline hydrochloride oral solution. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride oral solution that is written for healthcare professionals. </p>\n<p>For more information about sertraline hydrochloride oral solution, call 1-877-446-3679 (1-877-4-INFO-RX).</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"9\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in sertraline hydrochloride oral solution?</span>\n</p>\n<p>\n<span class=\"Bold\"> </span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span> sertraline hydrochloride</p>\n<p>\n<span class=\"Bold\"> </span>\n</p>\n<p>\n<span class=\"Bold\">Inactive ingredients: </span>\n</p>\n<p>\n<span class=\"Bold\">Oral solution:</span> glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)</p>\n<p> </p>\n<p>GREENSTONE<span class=\"Sup\">®</span> BRAND</p>\n<p>Distributed by:<br/>\n<span class=\"Bold\">Greenstone LLC</span>\n<br/>Morgantown, WV 26505 U.S.A.</p>\n<p>© 2024 Viatris Inc.</p>\n<p>The brands listed are trademarks of their respective owners.</p>\n<p>GST:MG:SERT:R1</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

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

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

Revised: 9/2024

{ "type": "p", "children": [], "text": "Revised: 9/2024" }

ALWAYS DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nALWAYS DISPENSE WITH MEDICATION GUIDE\n" }

NDC 59762-0067-1

{ "type": "p", "children": [], "text": "\nNDC 59762-0067-1\n" }

60 mL

{ "type": "p", "children": [], "text": "\n60 mL\n" }

sertralinehydrochlorideORAL SOLUTION CALIBRATED DROPPER ENCLOSED

{ "type": "p", "children": [], "text": "\nsertralinehydrochlorideORAL SOLUTION\nCALIBRATED DROPPER ENCLOSED\n" }

equivalent to20 mg/mL*of sertraline

{ "type": "p", "children": [], "text": "\nequivalent to20 mg/mL*of sertraline\n" }

Must Be Diluted Before Use(see side panel for instructions)

{ "type": "p", "children": [], "text": "\nMust Be Diluted Before Use(see side panel for instructions)\n" }

Rx only

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

Store at 20°C to 25°C (68°F to77°F); excursions permitted to15°C to 30°C (59°F to 86°F)[See USP Controlled RoomTemperature].

{ "type": "p", "children": [], "text": "\nStore at 20°C to 25°C (68°F to77°F); excursions permitted to15°C to 30°C (59°F to 86°F)[See USP Controlled RoomTemperature].\n" }

STORE UPRIGHT.

{ "type": "p", "children": [], "text": "STORE UPRIGHT." }

DOSAGE AND USE See accompanyingprescribing information.

{ "type": "p", "children": [], "text": "\nDOSAGE AND USE\nSee accompanyingprescribing information." }

* Each mL of solutioncontains 22.4 mg sertralinehydrochloride equivalent to20 mg of sertraline.

{ "type": "p", "children": [], "text": "* Each mL of solutioncontains 22.4 mg sertralinehydrochloride equivalent to20 mg of sertraline." }

Contains 12% alcohol.

{ "type": "p", "children": [], "text": "Contains 12% alcohol." }

THE PACKAGING OF THISPRODUCT CONTAINSDRY NATURAL RUBBER.

{ "type": "p", "children": [], "text": "\nTHE PACKAGING OF THISPRODUCT CONTAINSDRY NATURAL RUBBER.\n" }

GST:0067:1C:R1

{ "type": "p", "children": [], "text": "GST:0067:1C:R1" }

SERTRALINE HYDROCHLORIDE ORAL SOLUTION MUST BE DILUTED BEFORE USE.

{ "type": "p", "children": [], "text": "\nSERTRALINE HYDROCHLORIDE ORAL SOLUTION MUST BE DILUTED BEFORE USE.\n" }

MIXING INSTRUCTIONS

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

Just before taking, use the dropper provided to remove the required amount ofSertraline hydrochloride oral solution and mix with 4 oz (1/2 cup) of water, ginger ale,lemon/lime soda, lemonade or orange juice ONLY. Do not mix Sertraline hydrochlorideoral solution with anything other than the liquids listed. At times, a slight haze may appearafter mixing; this is normal. The medicine should be given immediately after mixing.DO NOT MIX IN ADVANCE.

{ "type": "p", "children": [], "text": "Just before taking, use the dropper provided to remove the required amount ofSertraline hydrochloride oral solution and mix with 4 oz (1/2 cup) of water, ginger ale,lemon/lime soda, lemonade or orange juice ONLY. Do not mix Sertraline hydrochlorideoral solution with anything other than the liquids listed. At times, a slight haze may appearafter mixing; this is normal. The medicine should be given immediately after mixing.DO NOT MIX IN ADVANCE." }

Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A.© 2024 Viatris Inc.Made in Spain

{ "type": "p", "children": [], "text": "Distributed by:\nGreenstone LLC\nMorgantown, WV 26505 U.S.A.© 2024 Viatris Inc.Made in Spain" }

Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]:

{ "type": "p", "children": [], "text": "Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]:" }

{ "type": "ul", "children": [ "Major depressive disorder (MDD) in adults", "Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older" ], "text": "" }

Do not initiate treatment with Sertraline HCl Capsules because the only available dose strengths are 150 mg and 200 mg. Use another sertraline HCl product for initial dosage, titration, and dosages below 150 mg once daily. Refer to Prescribing Information of the other sertraline HCl products for the recommended dosage for those products.

Sertraline HCl Capsules can be initiated in patients receiving 100 mg or 125 mg of sertraline HCl for at least one week. The recommended dosage of Sertraline HCl Capsules is 150 mg or 200 mg once daily. The maximum recommended dosage is 200 mg once daily.

Administer Sertraline HCl Capsules orally. Swallow capsules whole; do not open, crush, or chew.

Prior to initiating treatment with Sertraline HCl Capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Sertraline HCl Capsules. In addition, at least 14 days must elapse after stopping Sertraline HCl Capsules before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

Adverse reactions may occur upon discontinuation of Sertraline HCl Capsules [see Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping Sertraline HCl Capsules abruptly whenever possible. Given that dosage strengths lower than 150 mg of Sertraline HCl Capsules are not available, gradual dosage reduction will require the use of another sertraline HCl product.

150 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body.

{ "type": "p", "children": [], "text": "\n150 mg capsules: Hard shell capsules, with \"ALM\" printed axially on the opaque yellow cap and \"664\" printed axially on the opaque white body. " }

200 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body.

{ "type": "p", "children": [], "text": "\n200 mg capsules: Hard shell capsules, with \"ALM\" printed axially on the opaque yellowish green cap and \"672\" printed axially on the opaque white body." }

Dosage strengths are based on the active moiety, sertraline. The 150 mg capsules contain 168 mg of sertraline HCl. The 200 mg capsules contain 224 mg of sertraline HCl.

{ "type": "p", "children": [], "text": "Dosage strengths are based on the active moiety, sertraline. The 150 mg capsules contain 168 mg of sertraline HCl. The 200 mg capsules contain 224 mg of sertraline HCl." }

Sertraline HCl Capsules are contraindicated in patients:

{ "type": "p", "children": [], "text": "Sertraline HCl Capsules are contraindicated in patients:" }

{ "type": "ul", "children": [ "Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. ", "Taking pimozide [see Drug Interactions (7.1)]. ", "With known hypersensitivity to sertraline or the excipients in Sertraline HCl Capsules (e.g., anaphylaxis, angioedema) [see Adverse Reactions (6.1, 6.2)]. " ], "text": "" }

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.

<div class="scrollingtable"><table border="0" width="75%"> <caption> <span>Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients </span> </caption> <colgroup> <col width="9.74%"/> <col width="90.26%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Age Range</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Increases Compared to Placebo </span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">&lt;18 years old<br/> </td><td align="center" class="Rrule" valign="middle">14 additional patients <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">18 to 24 years old<br/> </td><td align="center" class="Rrule" valign="middle">5 additional patients <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Decreases Compared to Placebo </span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">25 to 64 years old<br/> </td><td align="center" class="Rrule" valign="middle">1 fewer patient <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">≥65 years old<br/> </td><td align="center" class="Rrule" valign="middle">6 fewer patients <br/> </td> </tr> </tbody> </table></div>

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Sertraline HCl Capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

SSRIs, including Sertraline HCl Capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of Sertraline HCl Capsules with MAOIs is contraindicated. In addition, do not initiate Sertraline HCl Capsules in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral ingestion or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Sertraline HCl Capsules, discontinue Sertraline HCl Capsules before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7.1)].

Monitor all patients taking Sertraline HCl Capsules for the emergence of serotonin syndrome. Discontinue treatment with Sertraline HCl Capsules and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Sertraline HCl Capsules with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

Drugs that interfere with serotonin reuptake inhibition, including Sertraline HCl Capsules, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients about the increased risk of bleeding associated with the concomitant use of Sertraline HCl Capsules and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

In patients with bipolar disorder, treating a depressive episode with Sertraline HCl Capsules or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials with another sertraline HCl product, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with sertraline. Prior to initiating treatment with Sertraline HCl Capsules, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration (2.3)].

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Dosage and Administration (2.5)].

Sertraline HCl has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. Sertraline HCl Capsules should be prescribed with caution in patients with a seizure disorder.

The pupillary dilation that occurs following use of many antidepressant drugs, including sertraline HCl, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Sertraline HCl Capsules, in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SSRIs, including Sertraline HCl Capsules. Cases with serum sodium lower than 110 mmol/L have been reported with another sertraline HCl product. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue Sertraline HCl Capsules and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations (8.5)].

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking another sertraline HCl product. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of Sertraline HCl Capsules. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish Sertraline HCl Capsules from benzodiazepines [see Drug Interactions (7.3)].

During post-marketing use of sertraline, cases of QTc prolongation and Torsade de Pointes (TdP) have been reported. Most reports were confounded by other risk factors. In a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects, there was a positive relationship between the length of the rate-adjusted QTc interval and serum sertraline concentration. Therefore, Sertraline HCl Capsules should be used with caution in patients with risk factors for QTc prolongation [see Drug Interactions (7.1), Clinical Pharmacology (12.2)].

Sertraline HCl Capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Use of SSRIs, including Sertraline HCl Capsules, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of Sertraline HCl Capsules and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

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 safety of Sertraline HCl Capsules for the treatment of MDD and OCD is based on adequate and well-controlled studies of another sertraline HCl product. Below is a display of adverse reactions of sertraline HCl (referred to as “sertraline” in this section) from those adequate and well-controlled studies in MDD, OCD, and other conditions.

The data described below reflect exposure in randomized, double-blind, placebo-controlled trials of sertraline in 3066 adults. These 3066 patients exposed to sertraline for 8 to 12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males.

The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline-treated patients (MDD, OCD, and other conditions) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 2). The following are the most common adverse reactions in trials of sertraline (≥5% and twice placebo) by indication that were not mentioned previously.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 2: Common Adverse Reactions (Greater than 2% of Adults with MDD, OCD, and Other Conditions Treated with Sertraline Hydrochloride and Greater than or Equal to Twice the Incidence of Placebo) in Pooled Placebo-Controlled Trials* </span> </caption> <colgroup> <col width="67.3%"/> <col width="16.34%"/> <col width="16.34%"/> </colgroup> <tfoot> <tr class="First Last"> <td colspan="3"><span class="Sup">(1) </span>Denominator used was for male patients only (n=1316 sertraline; n=973 placebo).<br/> <span class="Sup">*</span> Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Sertraline Hydrochloride<br/>(N=3066)</span> <br/> <span class="Bold">%</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Placebo </span> <br/> <span class="Bold">(N=2293) <br/>%</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Cardiac disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Palpitations<br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Eye disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Visual impairment<br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Gastrointestinal Disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Nausea<br/> </td><td align="center" class="Rrule" valign="middle">26<br/> </td><td align="center" class="Rrule" valign="middle">12<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Diarrhea/Loose Stools<br/> </td><td align="center" class="Rrule" valign="middle">20<br/> </td><td align="center" class="Rrule" valign="middle">10<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dry mouth<br/> </td><td align="center" class="Rrule" valign="middle">14<br/> </td><td align="center" class="Rrule" valign="middle">9<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dyspepsia<br/> </td><td align="center" class="Rrule" valign="middle">8<br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Constipation<br/> </td><td align="center" class="Rrule" valign="middle">6<br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Vomiting<br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td><td align="center" class="Rrule" valign="middle">1<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> General disorders and administration site conditions</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Fatigue<br/> </td><td align="center" class="Rrule" valign="middle">12<br/> </td><td align="center" class="Rrule" valign="middle">8<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Metabolism and nutrition disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Decreased appetite<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Nervous system disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dizziness<br/> </td><td align="center" class="Rrule" valign="middle">12<br/> </td><td align="center" class="Rrule" valign="middle">8<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Somnolence<br/> </td><td align="center" class="Rrule" valign="middle">11<br/> </td><td align="center" class="Rrule" valign="middle">6<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Tremor<br/> </td><td align="center" class="Rrule" valign="middle">9<br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Psychiatric Disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Insomnia<br/> </td><td align="center" class="Rrule" valign="middle">20<br/> </td><td align="center" class="Rrule" valign="middle">13<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Agitation<br/> </td><td align="center" class="Rrule" valign="middle">8<br/> </td><td align="center" class="Rrule" valign="middle">5<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Libido Decreased<br/> </td><td align="center" class="Rrule" valign="middle">6<br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Reproductive system and breast disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation failure <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">8<br/> </td><td align="center" class="Rrule" valign="middle">1<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Erectile dysfunction <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">4<br/> </td><td align="center" class="Rrule" valign="middle">1<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation disorder <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">3<br/> </td><td align="center" class="Rrule" valign="middle">0<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Male sexual dysfunction <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">2<br/> </td><td align="center" class="Rrule" valign="middle">0<br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Skin and subcutaneous tissue disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"> <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle">   Hyperhidrosis<br/> </td><td align="center" class="Rrule" valign="middle">7<br/> </td><td align="center" class="Rrule" valign="middle">3<br/> </td> </tr> </tbody> </table></div>

Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials

In all placebo-controlled studies, 368 (12%) of the 3066 patients who received sertraline discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline-treated patients:

Male and Female Sexual Dysfunction

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 3 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline -treated patients and twice placebo from pooled placebo-controlled trials of MDD, OCD, and other conditions. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido. 

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 3: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from Sertraline Hydrochloride Pooled Controlled Trials in Adults with MDD, OCD, and Other Conditions </span> </caption> <colgroup> <col width="37.5%"/> <col width="26.92%"/> <col width="35.58%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Sertraline Hydrochloride<br/> %</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Placebo <br/>%</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Men only </span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1316) </span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=973) </span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation failure <br/> </td><td align="center" class="Rrule" valign="middle">8 <br/> </td><td align="center" class="Rrule" valign="middle">1 <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Libido decreased <br/> </td><td align="center" class="Rrule" valign="middle">7 <br/> </td><td align="center" class="Rrule" valign="middle">2 <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Erectile dysfunction <br/> </td><td align="center" class="Rrule" valign="middle">4 <br/> </td><td align="center" class="Rrule" valign="middle">1 <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">   Ejaculation disorder <br/> </td><td align="center" class="Rrule" valign="top">3 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">   Male sexual dysfunction <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td><td align="center" class="Rrule" valign="top">0 <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Women only </span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1750) </span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1320) </span> <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top">   Libido decreased <br/> </td><td align="center" class="Rrule" valign="top">4 <br/> </td><td align="center" class="Rrule" valign="top">2 <br/> </td> </tr> </tbody> </table></div>

Adverse Reactions in Pediatric Patients

In 281 pediatric patients treated with sertraline in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 2 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.

Other Adverse Reactions Observed During the Premarketing Evaluation of Sertraline

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with sertraline were:

Cardiac disorders – tachycardia

Ear and labyrinth disorders – tinnitus

Endocrine disorders - hypothyroidism

Eye disorders - mydriasis, blurred vision

Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage

General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia

Hepatobiliary disorders - elevated liver enzymes

Immune system disorders - anaphylaxis

Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite

Musculoskeletal and connective tissue disorders – arthralgia, muscle spasms, tightness, or twitching

Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope

Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination

Renal and urinary disorders - hematuria

Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage

Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning

Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria

Vascular disorders - hemorrhage, hypertension, vasodilation

The following adverse reactions have been identified during post-approval use of another sertraline product. 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.

Bleeding or clotting disorders - increased coagulation times (altered platelet function)

Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [see Clinical Pharmacology (12.2)]

Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH

Eye disorders - blindness, optic neuritis, cataract

Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis

Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness

Immune system disorders - angioedema

Metabolism and nutrition disorders - hyponatremia, hyperglycemia

Musculoskeletal and connective tissue disorders - rhabdomyolysis, trismus

Nervous system disorders - serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis

Psychiatric disorders - psychosis, enuresis, paroniria

Renal and urinary disorders - acute renal failure

Respiratory, thoracic and mediastinal disorders - pulmonary hypertension, anosmia, hyposmia

Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)

Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

Table 4 includes clinically significant drug interactions with Sertraline HCl Capsules [see Clinical Pharmacology (12.3)]. 

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 4. Clinically-Significant Drug Interactions with Sertraline HCl Capsules </span> </caption> <colgroup> <col width="16.28%"/> <col width="83.72%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Monoamine Oxidase Inhibitors (MAOIs)</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">The concomitant use of SSRIs, including Sertraline HCl Capsules, and MAOIs increases the risk of serotonin syndrome. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline HCl Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[see Dosage and Administration (<a href="#Section_2.5">2.4</a>), Contraindications (<a href="#Section_4">4</a>), Warnings and Precautions (<a href="#Section_5.2">5.2</a>)]</span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Pimozide </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="middle">Concomitant use of pimozide and Sertraline HCl Capsules is contraindicated <span class="Italics">[see Contraindications (<a href="#Section_4">4</a>)]</span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Other Serotonergic Drugs</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Concomitant use of Sertraline HCl Capsules with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of Sertraline HCl Capsules and/or concomitant serotonergic drugs <span class="Italics">[see Warnings and Precautions (<a href="#Section_5.2">5.2</a>)]</span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants)</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">The concurrent use of an antiplatelet agent or anticoagulant with Sertraline HCl Capsules may potentiate the risk of bleeding. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Inform patients of the increased risk of bleeding associated with the concomitant use of Sertraline HCl Capsules and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio <span class="Italics">[see Warnings and Precautions (<a href="#Section_5.3">5.3</a>)]</span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Drugs Highly Bound to Plasma Protein</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline is highly bound to plasma protein. The concomitant use of Sertraline HCl Capsules with another drug that is highly bound to plasma protein may increase free concentrations of sertraline or other tightly-bound drugs in plasma <span class="Italics">[see Clinical Pharmacology (<a href="#Section_12.3">12.3</a>)]</span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor for adverse reactions and reduce dosage of Sertraline HCl Capsules or other protein-bound drugs as warranted. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Drugs Metabolized by CYP2D6</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline HCl Capsules are a CYP2D6 inhibitor <span class="Italics">[see Clinical Pharmacology (<a href="#Section_12.3">12.3</a>)]</span>. The concomitant use of Sertraline HCl Capsules with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Decrease the dosage of a CYP2D6 substrate if needed with concomitant Sertraline HCl Capsules use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if Sertraline HCl Capsules are discontinued. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Phenytoin </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Phenytoin is a narrow therapeutic index drug. Sertraline HCl Capsules may increase phenytoin concentrations. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention: </span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor phenytoin levels when initiating or titrating Sertraline HCl Capsules. Reduce phenytoin dosage if needed. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/>Drugs that Prolong the QTc Interval</span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of Sertraline HCl Capsules with other drugs which prolong the QTc interval <span class="Italics">[see Warnings and Precautions (<a href="#Section_5.10">5.10</a>), Clinical Pharmacology (<a href="#Section_12.2">12.2</a>)]</span>.<br/> </td> </tr> <tr class="Botrule Last"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">Pimozide is contraindicated for use with Sertraline HCl Capsules. Avoid the concomitant use of drugs known to prolong the QTc interval.<br/> </td> </tr> </tbody> </table></div>

Based on pharmacokinetic studies with another sertraline HCl formulation, no dosage adjustment of Sertraline HCl Capsules is necessary when used in combination with cimetidine. Additionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when Sertraline HCl Capsules is administered concomitantly [see Clinical Pharmacology (12.3)].

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking another sertraline HCl product. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of Sertraline HCl Capsules. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

Risk Summary

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations].

Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive (see Data). There are clinical considerations regarding neonates exposed to SSRIs, including Sertraline HCl Capsules, during the third trimester of pregnancy (see Clinical Considerations).

Although no malformations were observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses approximately 4 times the MRHD in rabbits on a mg/m2 basis in adults. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD (see Data).

The background risk of major birth defects and miscarriage for the indicated population are 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. Advise a pregnant woman of possible risks to the fetus when prescribing Sertraline HCl Capsules.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions

Use of Sertraline HCl Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3)].

Fetal/Neonatal Adverse Reactions

Exposure to SSRIs, including Sertraline HCl Capsules, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

When treating a pregnant woman with Sertraline HCl Capsules during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to sertraline in the third trimester of pregnancy for PPHN and drug discontinuation syndrome (see Data).

Data

Human Data

Third Trimester Exposure

Neonates exposed to sertraline and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions (5.2)].

Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997 to 2005 found a PPHN risk ratio of 2.4 (95% CI 1.2 to 4.3) associated with patient-reported maternal use of SSRIs “in early pregnancy” and a PPHN risk ratio of 3.6 (95% CI 1.2 to 8.3) associated with a combination of patient-reported maternal use of SSRIs “in early pregnancy” and an antenatal SSRI prescription “in later pregnancy”.

First Trimester Exposure

The weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline. A meta-analysis of studies suggest no increase in the risk of total malformations (summary odds ratio=1.01, 95% CI=0.88 to 1.17) or cardiac malformations (summary odds ratio=0.93, 95% CI=0.70 to 1.23) among offspring of women with first trimester exposure to sertraline. An increased risk of congenital cardiac defects, specifically septal defects, the most common type of congenital heart defect, was observed in some published epidemiologic studies with first trimester sertraline exposure; however, most of these studies were limited by the use of comparison populations that did not allow for the control of confounders such as the underlying depression and associated conditions and behaviors, which may be factors associated with increased risk of these malformations.

Animal Data

Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis in adults. There was no evidence of malformation at any dose level. When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.5 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg (3.9 times the MRHD on a mg/m2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in stillborn pups and pup deaths during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (1 times the MRHD on a mg/m2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown.

Risk Summary

Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk (see Data). There are no data on the effects of sertraline on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sertraline HCl Capsules and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Data

In a published pooled analysis of 53 mother-infant pairs, exclusively human milk-fed infants had an average of 2% (range 0% to 15%) of the sertraline serum levels measured in their mothers. No adverse reactions were observed in these infants.

The safety and effectiveness of Sertraline HCl Capsules have been established in the treatment of OCD in pediatric patients aged 6 to 17 [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)]. Safety and effectiveness in pediatric patients with OCD below the age of 6 have not been established.

Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted with another sertraline HCl product in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients.

Monitoring Pediatric Patients Treated with Sertraline HCl Capsules

Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [see Boxed Warning, Warnings and Precautions (5.1)]. Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with SSRIs including Sertraline HCl Capsules.

Weight Loss in Studies in Pediatric Patients with MDD

In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for MDD (n=373) with another sertraline HCl product, there was a difference in weight change between sertraline HCl and placebo of roughly 1 kg, for both pediatric patients ages 6 to 11 and pediatric patients ages 12 to 17, in both age groups representing a slight weight loss for the sertraline HCl group compared to a slight gain for the placebo group. For pediatric patients (ages 6 to 11), about 7% of the sertraline HCl-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for pediatric patients (ages 12 to 17), about 2% of sertraline HCl-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients.

A subset of patients who completed the randomized controlled trials in patients with MDD (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. Those subjects who completed 34 weeks of sertraline HCl treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. However, there are no studies that directly evaluate the long-term effects of sertraline HCl on the growth, development, and maturation in pediatric patients.

Juvenile Animal Toxicity Data

A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females.

In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period. The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

Of the total number of patients with MDD, OCD, and other conditions in clinical studies with another sertraline product, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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 conservative, 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 drug therapy.

In 354 geriatric subjects treated with another sertraline HCl product in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 2 [see Adverse Reactions (6.1)], except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients.

SSRIs, including sertraline HCl, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.8)].

Sertraline HCl Capsules are not recommended in patients with mild (Child-Pugh score 5 or 6), moderate (Child-Pugh score 7 to 10), or severe (Child-Pugh score 10 to 15) hepatic impairment. The effect of Sertraline HCl Capsules in patients with mild, moderate, or severe hepatic impairment was not studied.

Sertraline plasma exposure was higher in patients with mild hepatic impairment, compared with those with normal hepatic function [see Clinical Pharmacology (12.3)].

Dosage adjustments are not possible with the available strengths of Sertraline HCl Capsules.

No dose adjustment is necessary in patients with mild (eGFR 60 to 89 mL/minute/1.73 m2), moderate (eGFR 30 to 59 mL/minute/1.73 m2), or severe renal impairment (eGFR 15 to 29 mL/minute/1.73 m2). Sertraline exposure does not appear to be affected by renal impairment [see Clinical Pharmacology (12.3)].

Sertraline HCl Capsules contain sertraline, which is not a controlled substance.

In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of another sertraline HCl product, alprazolam, and d-amphetamine in humans, sertraline HCl did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.

The following have been reported with sertraline HCl tablet overdosage:

{ "type": "p", "children": [], "text": "The following have been reported with sertraline HCl tablet overdosage: " }

{ "type": "ul", "children": [ "Seizures, which may be delayed, and altered mental status including coma.", "Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.", "Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk)." ], "text": "" }

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

{ "type": "p", "children": [], "text": "Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations. " }

Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N • HCl is represented by the following structural formula:

{ "type": "p", "children": [], "text": "Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C17H17Cl2N • HCl is represented by the following structural formula:" }

Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol.

{ "type": "p", "children": [], "text": "Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. " }

Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.

{ "type": "p", "children": [], "text": " Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. " }

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors. Sertraline does not inhibit monoamine oxidase.

Alcohol

In healthy subjects, the acute cognitive and psychomotor effects of alcohol were not potentiated by sertraline.

Cardiac Electrophysiology

The effect of sertraline on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects. At 2-fold the maximum recommended daily dose (~3-fold the steady-state exposure for sertraline and N-desmethylsertraline), the largest mean ΔΔQTc was 10 ms with upper bound of two-sided 90% confidence interval of 12 ms. The length of the QTc interval was also positively correlated with serum concentrations of sertraline and N-desmethylsertraline concentrations. These concentration-based analyses, however, indicated a lesser effect on QTc at maximally observed concentration than in the primary analysis [see Warnings and Precautions (5.10), Adverse Reactions (6), Drug Interactions (7.1), Overdosage (10)].

Absorption

Following a single dose of Sertraline HCl Capsule at 150 mg, the mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5 to 8.4 hours post-dosing.

The average terminal elimination half-life of plasma sertraline is about 26 hours. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing. Linear dose-proportional pharmacokinetics are likely over a range of 150 to 200 mg.

Effect of Food

Administration of Sertraline HCl Capsules with food causes a small increase in Cmax and AUC.

Distribution

In vitro protein binding studies performed with radiolabeled 3H-sertraline showed that sertraline is highly bound to serum proteins (98%) in the range of 20 to 500 ng/mL. However, at up to 300 and 200 ng/mL concentrations, respectively, sertraline and N-desmethylsertraline did not alter the plasma protein binding of two other highly protein bound drugs, warfarin and propranolol.

Elimination

Metabolism

Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation. N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline.

Excretion

Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40 to 45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40 to 45% of the administered radioactivity was accounted for in feces, including 12 to 14% unchanged sertraline.

Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0 to 24-hour), Cmax and Cmin, with about a 5- to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14.

Specific Populations

Pediatric Patients

Sertraline pharmacokinetics were evaluated in a group of 61 pediatric patients (29 aged 6 to 12 years, 32 aged 13 to 17 years) including both males (N=28) and females (N=33). Relative to the adults, pediatric patients aged 6 to 12 years and 13 to 17 years showed about 22% lower AUC (0-24 hr) and Cmax values when plasma concentration was adjusted for weight. The half-life was similar to that in adults, and no gender-associated differences were observed [see Dosage and Administration (2.1), Use in Specific Populations (8.4)].

Geriatric Patients

Sertraline plasma clearance in a group of 16 (8 male, 8 female) elderly patients treated with 100 mg/day of another sertraline HCl product for 14 days was approximately 40% lower than in a similarly studied group of younger (25 to 32 year old) individuals. Steady-state, therefore, was achieved after 2 to 3 weeks in older patients. The same study showed a decreased clearance of desmethylsertraline in older males, but not in older females [see Use in Specific Populations (8.5)].

Patients with Hepatic Impairment

In patients with chronic mild liver impairment (N=10: 8 patients with Child-Pugh scores of 5-6; and 2 patients with Child-Pugh scores of 7-8) who received 50 mg of another sertraline HCl product per day for 21 days, sertraline clearance was reduced, resulting in approximately 3-fold greater exposure compared to age-matched volunteers with normal hepatic function (N=10). The exposure to desmethylsertraline was approximately 2-fold greater in patients with mild hepatic impairment compared to age-matched volunteers with normal hepatic function. There were no significant differences in plasma protein binding observed between the two groups. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied [see Use in Specific Populations (8.6)].

Patients with Renal Impairment

Sertraline is extensively metabolized and excretion of unchanged drug in urine is a minor route of elimination. In volunteers with mild to moderate (CLcr=30-60 mL/min), moderate to severe (CLcr=10-29 mL/min) or severe (receiving hemodialysis) renal impairment (N=10 each group), the pharmacokinetics and protein binding of 200 mg sertraline per day maintained for 21 days were not altered compared to age-matched volunteers (N=12) with no renal impairment. Thus, sertraline multiple dose pharmacokinetics appear to be unaffected by renal impairment [see Use in Specific Populations (8.7)].

Drug Interaction Studies

Pimozide

In a controlled study of a single dose (2 mg) of pimozide, 200 mg of another sertraline HCl product (once daily) co-administration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in ECG. The highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline. The effect on QTc interval and PK parameters at doses higher than 2 mg of pimozide are not known [see Drug Interactions (7.1)].

Drugs Metabolized by CYP2D6

Many antidepressant drugs (e.g., SSRIs, including sertraline, and most tricyclic antidepressant drugs) inhibit the biochemical activity of the drug metabolizing isozyme CYP2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by CYP2D6. The drugs for which this potential interaction is of greatest concern are those metabolized primarily by CYP2D6 and that have a narrow therapeutic index (e.g., tricyclic antidepressant drugs and the Type 1C antiarrhythmics propafenone and flecainide). The extent to which this interaction is an important clinical problem depends on the extent of the inhibition of CYP2D6 by the antidepressant and the therapeutic index of the co-administered drug. There is variability among the drugs effective in the treatment of MDD in the extent of clinically important 2D6 inhibition, and in fact sertraline at lower doses has a less prominent inhibitory effect on 2D6 than some others in the class. Nevertheless, even sertraline has the potential for clinically important 2D6 inhibition [see Drug Interactions (7.1)].

Phenytoin

Clinical trial data suggested that sertraline may increase phenytoin concentrations [see Drug Interactions (7.1)].

Cimetidine

In a study assessing disposition of sertraline (100 mg) on the second of 8 days of cimetidine administration (800 mg daily), there were increases in sertraline mean AUC (50%), Cmax (24%) and half-life (26%) compared to the placebo group [see Drug Interactions (7.2)].

Diazepam

In a study comparing the disposition of intravenously administered diazepam before and after 21 days of dosing with either sertraline (50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the sertraline group compared to a 19% decrease relative to baseline for the placebo group (p<0.03). There was a 23% increase in Tmax for desmethyldiazepam in the sertraline group compared to a 20% decrease in the placebo group (p<0.03) [see Drug Interactions (7.2)].

Lithium

In a placebo-controlled trial in normal volunteers, the administration of two doses of another sertraline HCl product did not significantly alter steady-state lithium levels or the renal clearance of lithium [see Drug Interactions (7.2)].

Tolbutamide

In a placebo-controlled trial in normal volunteers, administration of another sertraline HCl product for 22 days (including 200 mg/day for the final 13 days) caused a statistically significant 16% decrease from baseline in the clearance of tolbutamide following an intravenous 1000 mg dose. Sertraline administration did not noticeably change either the plasma protein binding or the apparent volume of distribution of tolbutamide, suggesting that the decreased clearance was due to a change in the metabolism of the drug [see Drug Interactions (7.2)].

Atenolol

Sertraline (100 mg) when administered to 10 healthy male subjects had no effect on the beta-adrenergic blocking ability of atenolol [see Drug Interactions (7.2)].

Digoxin

In a placebo-controlled trial in normal volunteers, administration of another sertraline HCl product for 17 days (including 200 mg/day for the last 10 days) did not change serum digoxin levels or digoxin renal clearance [see Drug Interactions (7.2)].

Drugs Metabolized by CYP3A4

In three separate in vivo interaction studies, sertraline was co-administered with CYP3A4 substrates, terfenadine, carbamazepine, or cisapride under steady-state conditions. The results of these studies indicated that sertraline did not increase plasma concentrations of terfenadine, carbamazepine, or cisapride. These data indicate that sertraline’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance. Results of the interaction study with cisapride indicate that sertraline 200 mg (once daily) induces the metabolism of cisapride (cisapride AUC and Cmax were reduced by about 35%) [see Drug Interactions (7.2)].

Microsomal Enzyme Induction

Preclinical studies have shown sertraline to induce hepatic microsomal enzymes. In clinical studies, sertraline was shown to induce hepatic enzymes minimally as determined by a small (5%) but statistically significant decrease in antipyrine half-life following administration of 200 mg of sertraline per day for 21 days. This small change in antipyrine half-life reflects a clinically insignificant change in hepatic metabolism.

Carcinogenesis

Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis. There was a dose-related increase of liver adenomas in male mice receiving sertraline at 10 to 40 mg/kg (0.25 to 1.0 times the MRHD on a mg/m2 basis). No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg (2 times the MRHD on a mg/m2 basis); this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10 to 40 mg/kg (0.5 to 2.0 times the MRHD on a mg/m2 basis) compared to placebo controls, this effect was not clearly drug related.

Mutagenesis

Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays: bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes.

Impairment of Fertility

A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (approximately 4 times the maximum recommended human dose on a mg/m2 basis in adults).

The efficacy of Sertraline HCl Capsules for the treatment of major depressive disorder (MDD) in adult patients is based upon adequate and well-controlled studies of another sertraline HCl product (referred to as “sertraline” in this section). The results of these adequate and well-controlled studies of sertraline are presented below.

The efficacy of sertraline as a treatment for MDD was established in two randomized, double-blind, placebo-controlled studies and one double-blind, randomized-withdrawal study following an open label study in adult (ages 18 to 65) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria for MDD (studies MDD-1 and MDD-2).

Overall, these studies demonstrated sertraline to be superior to placebo on the Hamilton Rating Scale for Depression (HAMD-17) and the Clinical Global Impression Severity (CGI-S) of Illness and Global Improvement (CGI-I) scores. Study MDD-2 was not readily interpretable regarding a dose response relationship for effectiveness.

A third study (Study MDD-3) involved adult outpatients meeting the DSM-III criteria for MDD who had responded by the end of an initial 8-week open treatment phase on sertraline 50 to 200 mg/day. These patients (n=295) were randomized to continuation on double-blind sertraline 50 to 200 mg/day or placebo for 44 weeks. A statistically significantly lower relapse rate was observed for patients taking sertraline compared to those on placebo: sertraline [n=11 (8%)] and placebo [n=31 (39%)]. The mean sertraline dose for completers was 70 mg/day.

Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.

The efficacy of Sertraline HCl Capsules for the treatment of OCD in adults and pediatric patients ages 6 to 17 years is based upon adequate and well-controlled studies of another sertraline HCl product (referred to as “sertraline” in this section). The results of these adequate and well-controlled studies of sertraline are presented below.

Adults with OCD

The effectiveness of sertraline in the treatment of OCD was demonstrated in three multicenter placebo-controlled studies of adult (age 18 to 65) non-depressed outpatients (Studies OCD-1, OCD-2, and OCD-3). Patients in all three studies had moderate to severe OCD (DSM-III or DSM-III-R) with mean baseline ratings on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score ranging from 23 to 25.  

Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

The effectiveness of sertraline was studied in the risk reduction of OCD relapse. In Study OCD-4, patients ranging in age from 18 to 79 meeting DSM-III-R criteria for OCD who had responded during a 52-week single-blind trial on sertraline 50 to 200 mg/day (n=224) were randomized to continuation of sertraline or to substitution of placebo for up to 28 weeks of observation for analysis of discontinuation due to relapse or insufficient clinical response. Response during the single-blind phase was defined as a decrease in the Y-BOCS score of ≥ 25% compared to baseline and a CGI-I of 1 (very much improved), 2 (much improved) or 3 (minimally improved). Insufficient clinical response during the double-blind phase indicated a worsening of the patient’s condition that resulted in study discontinuation, as assessed by the investigator. Relapse during the double-blind phase was defined as the following conditions being met (on three consecutive visits for 1 and 2, and condition 3 being met at visit 3):  

Patients receiving continued sertraline treatment experienced a statistically significantly lower rate of discontinuation due to relapse or insufficient clinical response over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

Pediatric Patients (ages 6 to 17 years) with OCD

The effectiveness of sertraline for the treatment of OCD was demonstrated in a 12-week, multicenter, placebo-controlled, parallel group study in a pediatric outpatient population (ages 6 to 17) (Study OCD-5). Sertraline (N=92) was initiated at doses of either 25 mg/day (pediatric patients ages 6 to 12) or 50 mg/day (pediatric patients ages 13 to 17), and then titrated at 3 and 4 day intervals (25 mg incremental dose for pediatric patients ages 6 to 12) or 1 week intervals (50 mg incremental dose for pediatric patients ages 13 to 17) over the next four weeks to a maximum dose of 200 mg/day, as tolerated. The mean dose for completers was 178 mg/day. Dosing was once a day in the morning or evening. Patients in this study had moderate to severe OCD (DSM-III-R) with mean baseline ratings on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score of 22. Patients receiving sertraline experienced a mean reduction of approximately 7 units on the CY-BOCS total score which was statistically significantly greater than the 3 unit reduction for placebo patients (n=95). Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

Sertraline HCl Capsules are supplied as:

{ "type": "p", "children": [], "text": "Sertraline HCl Capsules are supplied as:" }

150 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body.

{ "type": "p", "children": [], "text": "150 mg Capsules: Hard shell capsules, with \"ALM\" printed axially on the opaque yellow cap and \"664\" printed axially on the opaque white body." }

NDC 52427-664-30 Bottles of 30

{ "type": "p", "children": [], "text": "NDC 52427-664-30 Bottles of 30" }

200 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body.

{ "type": "p", "children": [], "text": "200 mg Capsules: Hard shell capsules, with \"ALM\" printed axially on the opaque yellowish green cap and \"672\" printed axially on the opaque white body." }

NDC 52427-672-30 Bottles of 30

{ "type": "p", "children": [], "text": "NDC 52427-672-30 Bottles of 30" }

Store at 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].

{ "type": "p", "children": [], "text": "Store at 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]." }

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

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

Suicidal Thoughts and Behaviors

{ "type": "p", "children": [], "text": "\n Suicidal Thoughts and Behaviors \n" }

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)]." }

Serotonin Syndrome

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

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Sertraline HCl Capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)].

{ "type": "p", "children": [], "text": "Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Sertraline HCl Capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]." }

Increased Risk of Bleeding

{ "type": "p", "children": [], "text": "\n Increased Risk of Bleeding \n" }

Inform patients about the concomitant use of Sertraline HCl Capsules with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients about the concomitant use of Sertraline HCl Capsules with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.3)]." }

Activation of Mania or Hypomania

{ "type": "p", "children": [], "text": "\n Activation of Mania or Hypomania \n" }

Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.4)]." }

Discontinuation Syndrome

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

Advise patients not to abruptly discontinue Sertraline HCl Capsules and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Sertraline HCl Capsules is discontinued [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients not to abruptly discontinue Sertraline HCl Capsules and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Sertraline HCl Capsules is discontinued [see Warnings and Precautions (5.5)]." }

Sexual Dysfunction

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

Advise patients that use of Sertraline HCl Capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.12)].

{ "type": "p", "children": [], "text": "Advise patients that use of Sertraline HCl Capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.12)]." }

Allergic Reactions and Reactions to FD&C Yellow No. 5 (Tartrazine)

{ "type": "p", "children": [], "text": "\n Allergic Reactions and Reactions to FD&C Yellow No. 5 (Tartrazine) \n" }

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.2)]." }

Advise patients that Sertraline HCl Capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons or in patients who also have an aspirin hypersensitivity [see Warnings and Precautions (5.11)].

{ "type": "p", "children": [], "text": "Advise patients that Sertraline HCl Capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons or in patients who also have an aspirin hypersensitivity [see Warnings and Precautions (5.11)]." }

Pregnancy

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

Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with Sertraline HCl Capsules. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to Sertraline HCl Capsules during pregnancy.

{ "type": "p", "children": [], "text": "Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with Sertraline HCl Capsules. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to Sertraline HCl Capsules during pregnancy." }

Inform women that Sertraline HCl Capsules may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)].

{ "type": "p", "children": [], "text": "Inform women that Sertraline HCl Capsules may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)]." }

Distributed by: Almatica Pharma LLC Morristown, NJ 07960 USA

{ "type": "p", "children": [], "text": "Distributed by: Almatica Pharma LLC Morristown, NJ 07960 USA" }

PI664-01

{ "type": "p", "children": [], "text": "PI664-01" }

<div class="scrollingtable"><table frame="box" rules="all" width="100%"> <tfoot> <tr class="First Last"> <td>This Medication Guide has been approved by the U.S. Food and Drug Administration.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center"><span class="Bold">MEDICATION GUIDE <br/>Sertraline (ser' tra leen) HCl <br/>capsules</span></td> </tr> <tr> <td><span class="Bold">What is the most important information I should know about Sertraline Hydrochloride (HCl) Capsules?</span> <br/> <span class="Bold">Sertraline HCl Capsules may cause serious side effects, including:</span> <ul> <li> <span class="Bold">Increased risk of suicidal thoughts or actions.</span> </li> <li>Sertraline HCl Capsules and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the <span class="Bold">first few months of treatment or when the dose is changed.</span> <br/> <span class="Bold">How can I watch for and try to prevent suicidal thoughts and actions?</span> <ul> <li>Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.</li> <li>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</li> <li>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions.</li> <li>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.</li> </ul> <br/> <span class="Bold">Call your healthcare provider or get emergency help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you:</span> <ul> <li>attempts to commit suicide</li> <li>acting aggressive or violent</li> <li>new or worse depression</li> <li>feeling agitated, restless, angry, or irritable</li> <li>an increase in activity and talking more than what is normal for you</li> <li>acting on dangerous impulses</li> <li>thoughts about suicide or dying</li> <li>new or worse anxiety or panic attacks</li> <li>trouble sleeping</li> <li>other unusual changes in behavior or mood</li> </ul> </li> </ul> </td> </tr> <tr> <td><span class="Bold">What are Sertraline HCl Capsules?</span> <br/>Sertraline HCl Capsules are a prescription medicine used to treat:<ul> <li>A certain type of depression called Major Depressive Disorder (MDD) in adults.</li> <li>Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older.</li> <li>It is not known if Sertraline HCl Capsules are safe and effective for use in children under 6 years of age with OCD or children with other behavioral health conditions.</li> </ul> </td> </tr> <tr> <td><span class="Bold">Do not take Sertraline HCl Capsules if you or your child:</span> <ul> <li>are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI).</li> <li>are being treated with the antibiotic linezolid or intravenous methylene blue.</li> <li>are taking the antipsychotic medicine pimozide because this can cause serious problems.</li> <li>are allergic to sertraline or any of the ingredients in Sertraline HCl Capsules. See the end of this Medication Guide for a complete list of ingredients in Sertraline HCl Capsules.</li> </ul>Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. <br/> <span class="Bold">Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Sertraline HCl Capsules.</span></td> </tr> <tr> <td><span class="Bold">Before taking Sertraline HCl Capsules, tell your healthcare provider about all medical conditions, including if you or your child:</span> <ul> <li>have or have had bleeding problems</li> <li>have, or have a family history of, bipolar disorder, mania, or hypomania</li> <li>have or have had seizures or convulsions</li> <li>have high pressure in the eye (glaucoma)</li> <li>have low sodium levels in your blood</li> <li>have heart problems</li> <li>have kidney or liver problems</li> <li>have an allergy or sensitivity to FD&amp;C Yellow No. 5 (Tartrazine)</li> <li>are pregnant or plan to become pregnant. Sertraline HCl Capsules may harm the unborn baby. Taking Sertraline HCl Capsules during the third trimester of pregnancy may cause the baby to have withdrawal symptoms after birth or may cause the baby to be at an increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risk to the mother and the unborn baby if Sertraline HCl Capsules are taken during pregnancy.<ul> <li>Tell your healthcare provider right away if you or your child becomes pregnant during treatment with Sertraline HCl Capsules.</li> <li>There is a pregnancy registry for females who are exposed to Sertraline HCl Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Sertraline HCl Capsules and their baby. If you or your child become pregnant during treatment with Sertraline HCl Capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.</li> </ul> </li> <li>are breastfeeding or plan to breastfeed. Sertraline HCl Capsules may pass into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Sertraline HCl Capsules.</li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines that you or your child take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/>Sertraline HCl Capsules and some medicines may interact with each other causing serious side effects. Sertraline HCl Capsules may affect the way other medicines work and other medicines may affect the way Sertraline HCl Capsules works. Sometimes the doses of other medicines will need to be changed during treatment with Sertraline HCl Capsules. Your healthcare provider will decide whether Sertraline HCl Capsules can be taken with other medicines. <br/> <span class="Bold">Especially tell your healthcare provider if you or your child take:</span> <ul> <li>medicines used to treat migraine headaches called triptans</li> <li>tricyclic antidepressants</li> <li>lithium</li> <li>tramadol, fentanyl, meperidine, methadone, or other opioids</li> <li>tryptophan</li> <li>buspirone</li> <li>amphetamines</li> <li>phenytoin</li> <li>St. John’s Wort</li> <li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants</li> <li>diuretics</li> </ul>Ask your healthcare provider if you are not sure if you or your child take any of these medicines. Your healthcare provider or pharmacist can tell you if it is safe to take Sertraline HCl Capsules with other medicines. <br/>Do not start or stop any other medicines during treatment with Sertraline HCl Capsules without talking to your healthcare provider first. Stopping Sertraline HCl Capsules suddenly may cause you or your child to have serious side effects. See, “<span class="Bold">What are the possible side effects of Sertraline HCl Capsules?</span>” <br/>Know the medicines you or your child take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.</td> </tr> <tr> <td><span class="Bold">How should I take Sertraline HCl Capsules?</span> <ul> <li>Take Sertraline HCl Capsules exactly as prescribed. Your healthcare provider may need to change the dose of Sertraline HCl Capsules until it is the right dose.</li> <li>Take Sertraline HCl Capsules with or without food.</li> <li>Swallow Sertraline HCl Capsules whole. Do not open, crush, or chew Sertraline HCl Capsules.</li> <li>If you miss a dose of Sertraline HCl Capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take 2 doses of Sertraline HCl Capsules at the same time.</li> <li>In case of overdose, get medical help or contact a live Poison Control expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.</li> </ul> </td> </tr> <tr> <td><span class="Bold">What are the possible side effects of Sertraline HCl Capsules?</span> <br/> <span class="Bold">Sertraline HCl Capsules may cause serious side effects, including:</span> <ul> <li>See, <span class="Bold">"What is the most important information I should know about Sertraline HCl Capsules?"</span> </li> <li> <span class="Bold">Serotonin Syndrome.</span> A potentially life-threatening problem called serotonin syndrome can happen when Sertraline HCl Capsules are taken with certain other medicines. See, <span class="Bold">“Who should not take Sertraline HCl Capsules?” Call your healthcare provider or go to the nearest hospital emergency room right away</span> if you or your child have any of the following signs and symptoms of serotonin syndrome:<ul> <li>agitation</li> <li>seeing or hearing things that are not real (hallucinations)</li> <li>confusion</li> <li>coma</li> <li>fast heartbeat</li> <li>changes in blood pressure</li> <li>dizziness</li> <li>sweating</li> <li>flushing</li> <li>high body temperature (hyperthermia)</li> <li>shaking (tremors), stiff muscles, or muscle twitching</li> <li>loss of coordination</li> <li>seizures</li> <li>nausea, vomiting, diarrhea</li> </ul> </li> <li> <span class="Bold">Increased chance of bleeding.</span> Taking Sertraline HCl Capsules with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider about any unusual bleeding or bruising.</li> <li> <span class="Bold">Manic episodes.</span> Manic episodes may happen in people with bipolar disorder who take Sertraline HCl Capsules. Symptoms may include:<ul> <li>greatly increased energy</li> <li>unusually grand ideas</li> <li>reckless behavior</li> <li>talking more or faster than usual</li> <li>racing thoughts</li> <li>severe problems sleeping</li> <li>excessive happiness or irritability</li> </ul> </li> <li> <span class="Bold">Discontinuation syndrome.</span> Suddenly stopping Sertraline HCl Capsules may cause you or your child to have serious side effects. Your healthcare provider may want to decrease the Sertraline HCl Capsules dose slowly. Symptoms may include:<ul> <li>nausea</li> <li>sweating</li> <li>changes in mood</li> <li>irritability and agitation</li> <li>dizziness</li> <li>electric shock feeling (paresthesia)</li> <li>tremor</li> <li>anxiety</li> <li>confusion</li> <li>headache</li> <li>tiredness</li> <li>problems sleeping</li> <li>hypomania</li> <li>ringing in the ears (tinnitus)</li> <li>seizures</li> </ul> </li> <li> <span class="Bold">Seizures or convulsions.</span> </li> <li> <span class="Bold">Eye problems (angle-closure glaucoma).</span> Sertraline HCl Capsules may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You or your child may want to undergo an eye examination to see if you or your child are at risk and receive preventative treatment if you are. Call your healthcare provider if you or your child have eye pain, changes in vision, or swelling or redness in or around the eye.</li> <li> <span class="Bold">Low sodium levels in your blood (hyponatremia).</span> Low sodium levels in the blood that may be serious and may cause death, can happen during treatment with Sertraline HCl Capsules. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in the blood. Stop taking Sertraline HCl Capsules and call your healthcare provider or get emergency medical help right away if you have any signs or symptoms of hyponatremia. Signs and symptoms may include: <ul> <li>headache</li> <li>difficulty concentrating</li> <li>memory changes</li> <li>confusion</li> <li>weakness and unsteadiness which can lead to falls</li> </ul> <span class="Bold">In more severe or more sudden cases, signs and symptoms include:</span> <ul> <li>seeing or hearing things that are not real (hallucinations)</li> <li>fainting</li> <li>seizures</li> <li>coma</li> <li>stopping breathing (respiratory arrest)</li> </ul> </li> <li> <span class="Bold">Changes in the electrical activity of the heart.</span> Changes in the electrical activity of the heart including QTc prolongation and Torsade de Pointes (TdP) have happened in people who take sertraline which is the medicine contained in Sertraline HCl Capsules. </li> <li> <span class="Bold">FD&amp;C Yellow No. 5.</span> Sertraline HCl Capsules contains FD&amp;C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.</li> <li> <span class="Bold">Sexual problems (dysfunction).</span> Taking selective serotonin reuptake inhibitors (SSRIs), including Sertraline HCl Capsules, may cause sexual problems.<ul> <li>Symptoms in males may include:<ul> <li>Delayed ejaculation or inability to have an ejaculation</li> <li>Decreased sex drive</li> <li>Problems getting or keeping an erection</li> </ul> </li> <li>Symptoms in females may include:<ul> <li>Decreased sex drive</li> <li>Delayed orgasm or inability to have an orgasm</li> </ul> </li> </ul> Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Sertraline HCl Capsules. There may be treatments your healthcare provider can suggest.</li> </ul> <span class="Bold">The most common side effects of Sertraline HCl Capsules include:</span> <ul> <li>nausea, diarrhea, or loose stool</li> <li>tremor or shaking</li> <li>indigestion</li> <li>decreased appetite</li> <li>increased sweating</li> <li>sexual problems including decreased libido and ejaculation problems</li> </ul>These are not all the possible side effects of Sertraline HCl Capsules. <br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr> <td><span class="Bold">How should I store Sertraline HCl Capsules?</span> <ul> <li>Store Sertraline HCl Capsules at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Keep Sertraline HCl Capsules bottle tightly closed.</li> </ul> <span class="Bold">Keep Sertraline HCl Capsules and all medicines out of the reach of children.</span></td> </tr> <tr> <td><span class="Bold">General information about the safe and effective use of Sertraline HCl Capsules.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sertraline HCl Capsules for a condition for which it was not prescribed. Do not give Sertraline HCl Capsules to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about Sertraline HCl Capsules that is written for healthcare professionals.</td> </tr> <tr class="Last"> <td><span class="Bold">What are the ingredients in Sertraline HCl Capsules?</span> <br/> <span class="Bold">Active ingredient:</span> sertraline hydrochloride<br/> <span class="Bold">Inactive ingredients:</span> croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&amp;C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&amp;C Blue No. 1 and FD&amp;C Yellow No. 5 as color additives. <br/> <br/>Distributed by: <br/>Almatica Pharma LLC <br/>Morristown, NJ 07960 USA <br/>For more information about Sertraline Hydrochloride Capsules call Almatica Pharma LLC at 1-877-447-7979.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table frame=\"box\" rules=\"all\" width=\"100%\">\n<tfoot>\n<tr class=\"First Last\">\n<td>This Medication Guide has been approved by the U.S. Food and Drug Administration.</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\"><span class=\"Bold\">MEDICATION GUIDE <br/>Sertraline (ser' tra leen) HCl <br/>capsules</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What is the most important information I should know about Sertraline Hydrochloride (HCl) Capsules?</span>\n<br/>\n<span class=\"Bold\">Sertraline HCl Capsules may cause serious side effects, including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Increased risk of suicidal thoughts or actions.</span>\n</li>\n<li>Sertraline HCl Capsules and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the <span class=\"Bold\">first few months of treatment or when the dose is changed.</span>\n<br/>\n<span class=\"Bold\">How can I watch for and try to prevent suicidal thoughts and actions?</span>\n<ul>\n<li>Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.</li>\n<li>Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.</li>\n<li>Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions.</li>\n<li>Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.</li>\n</ul>\n<br/>\n<span class=\"Bold\">Call your healthcare provider or get emergency help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you:</span>\n<ul>\n<li>attempts to commit suicide</li>\n<li>acting aggressive or violent</li>\n<li>new or worse depression</li>\n<li>feeling agitated, restless, angry, or irritable</li>\n<li>an increase in activity and talking more than what is normal for you</li>\n<li>acting on dangerous impulses</li>\n<li>thoughts about suicide or dying</li>\n<li>new or worse anxiety or panic attacks</li>\n<li>trouble sleeping</li>\n<li>other unusual changes in behavior or mood</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What are Sertraline HCl Capsules?</span>\n<br/>Sertraline HCl Capsules are a prescription medicine used to treat:<ul>\n<li>A certain type of depression called Major Depressive Disorder (MDD) in adults.</li>\n<li>Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older.</li>\n<li>It is not known if Sertraline HCl Capsules are safe and effective for use in children under 6 years of age with OCD or children with other behavioral health conditions.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Do not take Sertraline HCl Capsules if you or your child:</span>\n<ul>\n<li>are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI).</li>\n<li>are being treated with the antibiotic linezolid or intravenous methylene blue.</li>\n<li>are taking the antipsychotic medicine pimozide because this can cause serious problems.</li>\n<li>are allergic to sertraline or any of the ingredients in Sertraline HCl Capsules. See the end of this Medication Guide for a complete list of ingredients in Sertraline HCl Capsules.</li>\n</ul>Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. <br/>\n<span class=\"Bold\">Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Sertraline HCl Capsules.</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Before taking Sertraline HCl Capsules, tell your healthcare provider about all medical conditions, including if you or your child:</span>\n<ul>\n<li>have or have had bleeding problems</li>\n<li>have, or have a family history of, bipolar disorder, mania, or hypomania</li>\n<li>have or have had seizures or convulsions</li>\n<li>have high pressure in the eye (glaucoma)</li>\n<li>have low sodium levels in your blood</li>\n<li>have heart problems</li>\n<li>have kidney or liver problems</li>\n<li>have an allergy or sensitivity to FD&amp;C Yellow No. 5 (Tartrazine)</li>\n<li>are pregnant or plan to become pregnant. Sertraline HCl Capsules may harm the unborn baby. Taking Sertraline HCl Capsules during the third trimester of pregnancy may cause the baby to have withdrawal symptoms after birth or may cause the baby to be at an increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risk to the mother and the unborn baby if Sertraline HCl Capsules are taken during pregnancy.<ul>\n<li>Tell your healthcare provider right away if you or your child becomes pregnant during treatment with Sertraline HCl Capsules.</li>\n<li>There is a pregnancy registry for females who are exposed to Sertraline HCl Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Sertraline HCl Capsules and their baby. If you or your child become pregnant during treatment with Sertraline HCl Capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.</li>\n</ul>\n</li>\n<li>are breastfeeding or plan to breastfeed. Sertraline HCl Capsules may pass into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Sertraline HCl Capsules.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines that you or your child take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/>Sertraline HCl Capsules and some medicines may interact with each other causing serious side effects. Sertraline HCl Capsules may affect the way other medicines work and other medicines may affect the way Sertraline HCl Capsules works. Sometimes the doses of other medicines will need to be changed during treatment with Sertraline HCl Capsules. Your healthcare provider will decide whether Sertraline HCl Capsules can be taken with other medicines. <br/>\n<span class=\"Bold\">Especially tell your healthcare provider if you or your child take:</span>\n<ul>\n<li>medicines used to treat migraine headaches called triptans</li>\n<li>tricyclic antidepressants</li>\n<li>lithium</li>\n<li>tramadol, fentanyl, meperidine, methadone, or other opioids</li>\n<li>tryptophan</li>\n<li>buspirone</li>\n<li>amphetamines</li>\n<li>phenytoin</li>\n<li>St. John’s Wort</li>\n<li>medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants</li>\n<li>diuretics</li>\n</ul>Ask your healthcare provider if you are not sure if you or your child take any of these medicines. Your healthcare provider or pharmacist can tell you if it is safe to take Sertraline HCl Capsules with other medicines. <br/>Do not start or stop any other medicines during treatment with Sertraline HCl Capsules without talking to your healthcare provider first. Stopping Sertraline HCl Capsules suddenly may cause you or your child to have serious side effects. See, “<span class=\"Bold\">What are the possible side effects of Sertraline HCl Capsules?</span>” <br/>Know the medicines you or your child take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">How should I take Sertraline HCl Capsules?</span>\n<ul>\n<li>Take Sertraline HCl Capsules exactly as prescribed. Your healthcare provider may need to change the dose of Sertraline HCl Capsules until it is the right dose.</li>\n<li>Take Sertraline HCl Capsules with or without food.</li>\n<li>Swallow Sertraline HCl Capsules whole. Do not open, crush, or chew Sertraline HCl Capsules.</li>\n<li>If you miss a dose of Sertraline HCl Capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take 2 doses of Sertraline HCl Capsules at the same time.</li>\n<li>In case of overdose, get medical help or contact a live Poison Control expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">What are the possible side effects of Sertraline HCl Capsules?</span>\n<br/>\n<span class=\"Bold\">Sertraline HCl Capsules may cause serious side effects, including:</span>\n<ul>\n<li>See, <span class=\"Bold\">\"What is the most important information I should know about Sertraline HCl Capsules?\"</span>\n</li>\n<li>\n<span class=\"Bold\">Serotonin Syndrome.</span> A potentially life-threatening problem called serotonin syndrome can happen when Sertraline HCl Capsules are taken with certain other medicines. See, <span class=\"Bold\">“Who should not take Sertraline HCl Capsules?” Call your healthcare provider or go to the nearest hospital emergency room right away</span> if you or your child have any of the following signs and symptoms of serotonin syndrome:<ul>\n<li>agitation</li>\n<li>seeing or hearing things that are not real (hallucinations)</li>\n<li>confusion</li>\n<li>coma</li>\n<li>fast heartbeat</li>\n<li>changes in blood pressure</li>\n<li>dizziness</li>\n<li>sweating</li>\n<li>flushing</li>\n<li>high body temperature (hyperthermia)</li>\n<li>shaking (tremors), stiff muscles, or muscle twitching</li>\n<li>loss of coordination</li>\n<li>seizures</li>\n<li>nausea, vomiting, diarrhea</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Increased chance of bleeding.</span> Taking Sertraline HCl Capsules with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider about any unusual bleeding or bruising.</li>\n<li>\n<span class=\"Bold\">Manic episodes.</span> Manic episodes may happen in people with bipolar disorder who take Sertraline HCl Capsules. Symptoms may include:<ul>\n<li>greatly increased energy</li>\n<li>unusually grand ideas</li>\n<li>reckless behavior</li>\n<li>talking more or faster than usual</li>\n<li>racing thoughts</li>\n<li>severe problems sleeping</li>\n<li>excessive happiness or irritability</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Discontinuation syndrome.</span> Suddenly stopping Sertraline HCl Capsules may cause you or your child to have serious side effects. Your healthcare provider may want to decrease the Sertraline HCl Capsules dose slowly. Symptoms may include:<ul>\n<li>nausea</li>\n<li>sweating</li>\n<li>changes in mood</li>\n<li>irritability and agitation</li>\n<li>dizziness</li>\n<li>electric shock feeling (paresthesia)</li>\n<li>tremor</li>\n<li>anxiety</li>\n<li>confusion</li>\n<li>headache</li>\n<li>tiredness</li>\n<li>problems sleeping</li>\n<li>hypomania</li>\n<li>ringing in the ears (tinnitus)</li>\n<li>seizures</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Seizures or convulsions.</span>\n</li>\n<li>\n<span class=\"Bold\">Eye problems (angle-closure glaucoma).</span> Sertraline HCl Capsules may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You or your child may want to undergo an eye examination to see if you or your child are at risk and receive preventative treatment if you are. Call your healthcare provider if you or your child have eye pain, changes in vision, or swelling or redness in or around the eye.</li>\n<li>\n<span class=\"Bold\">Low sodium levels in your blood (hyponatremia).</span> Low sodium levels in the blood that may be serious and may cause death, can happen during treatment with Sertraline HCl Capsules. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in the blood. Stop taking Sertraline HCl Capsules and call your healthcare provider or get emergency medical help right away if you have any signs or symptoms of hyponatremia. Signs and symptoms may include: <ul>\n<li>headache</li>\n<li>difficulty concentrating</li>\n<li>memory changes</li>\n<li>confusion</li>\n<li>weakness and unsteadiness which can lead to falls</li>\n</ul>\n<span class=\"Bold\">In more severe or more sudden cases, signs and symptoms include:</span>\n<ul>\n<li>seeing or hearing things that are not real (hallucinations)</li>\n<li>fainting</li>\n<li>seizures</li>\n<li>coma</li>\n<li>stopping breathing (respiratory arrest)</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Changes in the electrical activity of the heart.</span> Changes in the electrical activity of the heart including QTc prolongation and Torsade de Pointes (TdP) have happened in people who take sertraline which is the medicine contained in Sertraline HCl Capsules. </li>\n<li>\n<span class=\"Bold\">FD&amp;C Yellow No. 5.</span> Sertraline HCl Capsules contains FD&amp;C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.</li>\n<li>\n<span class=\"Bold\">Sexual problems (dysfunction).</span> Taking selective serotonin reuptake inhibitors (SSRIs), including Sertraline HCl Capsules, may cause sexual problems.<ul>\n<li>Symptoms in males may include:<ul>\n<li>Delayed ejaculation or inability to have an ejaculation</li>\n<li>Decreased sex drive</li>\n<li>Problems getting or keeping an erection</li>\n</ul>\n</li>\n<li>Symptoms in females may include:<ul>\n<li>Decreased sex drive</li>\n<li>Delayed orgasm or inability to have an orgasm</li>\n</ul>\n</li>\n</ul> Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Sertraline HCl Capsules. There may be treatments your healthcare provider can suggest.</li>\n</ul>\n<span class=\"Bold\">The most common side effects of Sertraline HCl Capsules include:</span>\n<ul>\n<li>nausea, diarrhea, or loose stool</li>\n<li>tremor or shaking</li>\n<li>indigestion</li>\n<li>decreased appetite</li>\n<li>increased sweating</li>\n<li>sexual problems including decreased libido and ejaculation problems</li>\n</ul>These are not all the possible side effects of Sertraline HCl Capsules. <br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr>\n<td><span class=\"Bold\">How should I store Sertraline HCl Capsules?</span>\n<ul>\n<li>Store Sertraline HCl Capsules at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Keep Sertraline HCl Capsules bottle tightly closed.</li>\n</ul>\n<span class=\"Bold\">Keep Sertraline HCl Capsules and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">General information about the safe and effective use of Sertraline HCl Capsules.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sertraline HCl Capsules for a condition for which it was not prescribed. Do not give Sertraline HCl Capsules to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about Sertraline HCl Capsules that is written for healthcare professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td><span class=\"Bold\">What are the ingredients in Sertraline HCl Capsules?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> sertraline hydrochloride<br/>\n<span class=\"Bold\">Inactive ingredients:</span> croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&amp;C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&amp;C Blue No. 1 and FD&amp;C Yellow No. 5 as color additives. <br/>\n<br/>Distributed by: <br/>Almatica Pharma LLC <br/>Morristown, NJ 07960 USA <br/>For more information about Sertraline Hydrochloride Capsules call Almatica Pharma LLC at 1-877-447-7979.</td>\n</tr>\n</tbody>\n</table></div>" }

Revised: 8/2023 MG664-01

{ "type": "p", "children": [], "text": "Revised: 8/2023 MG664-01" }

NDC 52427-664-30

{ "type": "p", "children": [], "text": "\nNDC 52427-664-30" }

Sertraline HCl Capsules

{ "type": "p", "children": [], "text": "\nSertraline HCl Capsules\n" }

150 mg

{ "type": "p", "children": [], "text": "\n150 mg\n" }

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

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

Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

{ "type": "p", "children": [], "text": "Contains FD&C Yellow No. 5 (tartrazine) as a color additive." }

NDC 52427-672-30

{ "type": "p", "children": [], "text": "\nNDC 52427-672-30" }

Sertraline HCl Capsules

{ "type": "p", "children": [], "text": "\nSertraline HCl Capsules\n" }

200 mg

{ "type": "p", "children": [], "text": "\n200 mg\n" }

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

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

Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

{ "type": "p", "children": [], "text": "Contains FD&C Yellow No. 5 (tartrazine) as a color additive." }

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets are indicated for the treatment of the following\n \n [See\n \n Clinical Studies (14)]\n \n :\n\n " }

{ "type": "ul", "children": [ "Major depressive disorder (MDD)", "Obsessive-compulsive disorder (OCD)", "Panic disorder (PD)", "Posttraumatic stress disorder (PTSD)", "Social anxiety disorder (SAD)", "Premenstrual dysphoric disorder (PMDD)" ], "text": "" }

The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.

For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <col width="34.76%"/> <col width="23.9%"/> <col width="41.36%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="3" valign="middle"><span class="Bold">Table 1: Recommended Daily Dosage of Sertraline Hydrochloride in Patients with MDD, OCD, PD, PTSD, and SAD</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold">  Indication</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Starting Dose</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Therapeutic Range</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="3" valign="middle"><span class="Bold">  Adults</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">  MDD <br/> </td><td align="center" class="Rrule" valign="middle">50 mg <br/> </td><td align="center" class="Rrule" rowspan="3" valign="middle">50 to 200 mg <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">  OCD <br/> </td><td align="center" class="Rrule" valign="middle">50 mg <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">  PD, PTSD, SAD <br/> </td><td align="center" class="Rrule" valign="middle">25 mg <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="3" valign="middle"><span class="Bold">  Pediatric Patients</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">  OCD (ages 6 to 12 years old) <br/> </td><td align="center" class="Rrule" valign="middle">25 mg <br/> </td><td align="center" class="Rrule" rowspan="2" valign="middle">50 to 200 mg <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle">  OCD (ages 13 to 17 years old) <br/> </td><td align="center" class="Rrule" valign="middle">50 mg <br/> </td> </tr> </tbody> </table></div>

The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

Prior to initiating treatment with sertraline hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4)].

Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)]. The use of sertraline hydrochloride tablets in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride tablets. In addition, at least 14 days must elapse after stopping sertraline hydrochloride tablets before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].

Adverse reactions may occur upon discontinuation of sertraline hydrochloride tablets [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping sertraline hydrochloride tablets abruptly whenever possible.

Sertraline Hydrochloride Tablets USP,100 mgare yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and �8’ on the other side.

{ "type": "p", "children": [], "text": "\nSertraline Hydrochloride Tablets USP,100 mgare yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and �8’ on the other side.\n " }

Sertraline hydrochloride tablets are contraindicated in patients:

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets are contraindicated in patients:" }

{ "type": "ul", "children": [ "Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome\n \n [See\n \n Warnings and Precautions (5.2),\n \n Drug Interactions (7.1)]\n \n .\n \n ", "Taking pimozide\n \n [See\n \n Drug Interactions (7.1)]\n \n .\n \n ", "With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema)\n \n [See\n \n Adverse Reactions (6.1,\n \n 6.2)].\n \n \n" ], "text": "" }

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients</span> </caption> <col width="9.74%"/> <col width="90.26%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle"><span class="Bold">Age Range (years)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Increases Compared to Placebo</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">&lt;18 <br/> </td><td align="center" class="Rrule" valign="middle">14 additional patients <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">18 to 24 <br/> </td><td align="center" class="Rrule" valign="middle">5 additional patients <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold">Decreases Compared to Placebo</span> <br/> </td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" valign="middle">25 to 64 <br/> </td><td align="center" class="Rrule" valign="middle">1 fewer patient <br/> </td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule" valign="middle">≥65 <br/> </td><td align="center" class="Rrule" valign="middle">6 fewer patients <br/> </td> </tr> </tbody> </table></div>

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing sertraline hydrochloride, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use ofother serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [See Contraindications (4), Drug Interactions (7.1)]. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of sertraline hydrochloride with MAOIs is contraindicated. In addition, do not initiate sertraline hydrochloride in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking sertraline hydrochloride tablets, discontinue sertraline hydrochloride tablets before initiating treatment with the MAOI [See Contraindications (4), Drug Interactions (7.1)].

Monitor all patients taking sertraline hydrochloride for the emergence of serotonin syndrome. Discontinue treatment with sertraline hydrochloride and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of sertraline hydrochloride with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

Drugs that interfere with serotonin reuptake inhibition, including sertraline hydrochloride, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with aless than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

In patients with bipolar disorder, treating a depressive episode with sertraline hydrochloride or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with sertraline hydrochloride. Prior to initiating treatment with sertraline hydrochloride, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration (2.6)].

Sertraline hydrochloride has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. Sertraline hydrochloride should be prescribed with caution in patients with a seizure disorder.

The pupillary dilation that occurs following use of many antidepressant drugs including sertraline hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including sertraline hydrochloride, in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including sertraline hydrochloride. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In patients with symptomatic hyponatremia, discontinue sertraline hydrochloride and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [See Use in Specific Populations (8.5)] .

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline hydrochloride. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish sertraline hydrochloride from benzodiazepines [See Drug Interactions (7.3)] .

During post-marketing use of sertraline, cases of QTc prolongation and Torsade de Pointes (TdP) have been reported. Most reports were confounded by other risk factors. In a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in    54 healthy adult subjects, there was a positive relationship between the length of the rate-adjusted QTc interval and serum sertraline concentration. Therefore, sertraline hydrochloride should be used with caution in patients with risk factors for QTc prolongation   [See Drug Interactions (7.1), Clinical Pharmacology (12.2)].

Use of SSRIs, including sertraline hydrochloride, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)] . In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of sertraline hydrochloride and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

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 are from randomized, double-blind, placebo-controlled trials of sertraline hydrochloride (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to sertraline hydrochloride for 8 to12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males. The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline hydrochloride-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD*</span> </caption> <col width="67.3%"/> <col width="16.34%"/> <col width="16.34%"/> <tfoot> <tr class="First Last"> <td colspan="3"><span class="Sup">(1)</span>Denominator used was for male patients only (n=1316 sertraline hydrochloride; n=973 placebo). <br/> <span class="Sup">*</span>Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients. </td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Sertraline Hydrochloride (N=3066)</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Placebo</span> <br/> <span class="Bold">(N=2293)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Cardiac disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Palpitations <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Eye disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Visual impairment <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Gastrointestinal disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Nausea <br/> </td><td align="center" class="Rrule" valign="middle">26% <br/> </td><td align="center" class="Rrule" valign="middle">12% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Diarrhea/Loose stools <br/> </td><td align="center" class="Rrule" valign="middle">20% <br/> </td><td align="center" class="Rrule" valign="middle">10% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dry mouth <br/> </td><td align="center" class="Rrule" valign="middle">14% <br/> </td><td align="center" class="Rrule" valign="middle">9% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dyspepsia <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Constipation <br/> </td><td align="center" class="Rrule" valign="middle">6% <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Vomiting <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td><td align="center" class="Rrule" valign="middle">1% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> General disorders and administration site conditions</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Fatigue <br/> </td><td align="center" class="Rrule" valign="middle">12% <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Metabolism and nutrition disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Decreased appetite <br/> </td><td align="center" class="Rrule" valign="middle">7% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Nervous system disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Dizziness <br/> </td><td align="center" class="Rrule" valign="middle">12% <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Somnolence <br/> </td><td align="center" class="Rrule" valign="middle">11% <br/> </td><td align="center" class="Rrule" valign="middle">6% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Tremor <br/> </td><td align="center" class="Rrule" valign="middle">9% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Psychiatric Disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Insomnia <br/> </td><td align="center" class="Rrule" valign="middle">20% <br/> </td><td align="center" class="Rrule" valign="middle">13% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Agitation <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td><td align="center" class="Rrule" valign="middle">5% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Libido decreased <br/> </td><td align="center" class="Rrule" valign="middle">6% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Reproductive system and breast disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation failure <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td><td align="center" class="Rrule" valign="middle">1% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Erectile dysfunction <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td><td align="center" class="Rrule" valign="middle">1% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation disorder <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">3% <br/> </td><td align="center" class="Rrule" valign="middle">0% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Male sexual dysfunction <span class="Sup">(1)</span> <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td><td align="center" class="Rrule" valign="middle">0% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Skin and subcutaneous tissue disorders</span> <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle">  <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle">   Hyperhidrosis <br/> </td><td align="center" class="Rrule" valign="middle">7% <br/> </td><td align="center" class="Rrule" valign="middle">3% <br/> </td> </tr> </tbody> </table></div>

Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received sertraline hydrochloride discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline hydrochloride-treated patients:

Male and Female Sexual Dysfunction Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline hydrochloride-treated patients and twice placebo from pooled placebo-controlled trials. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido. 

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from Sertraline Hydrochloride Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD</span> </caption> <col width="37.5%"/> <col width="26.92%"/> <col width="35.58%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" valign="middle">  <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Sertraline Hydrochloride</span> <br/> </td><td align="center" class="Rrule" valign="middle"><span class="Bold">Placebo</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Men only</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1316)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=973)</span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Ejaculation failure <br/> </td><td align="center" class="Rrule" valign="middle">8% <br/> </td><td align="center" class="Rrule" valign="middle">1% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Libido decreased <br/> </td><td align="center" class="Rrule" valign="middle">7% <br/> </td><td align="center" class="Rrule" valign="middle">2% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle">   Erectile dysfunction <br/> </td><td align="center" class="Rrule" valign="middle">4% <br/> </td><td align="center" class="Rrule" valign="middle">1% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">   Ejaculation disorder <br/> </td><td align="center" class="Rrule" valign="top">3% <br/> </td><td align="center" class="Rrule" valign="top">0% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top">   Male sexual dysfunction <br/> </td><td align="center" class="Rrule" valign="top">2% <br/> </td><td align="center" class="Rrule" valign="top">0% <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Bold"> Women only</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1750)</span> <br/> </td><td align="center" class="Rrule" valign="top"><span class="Bold">(N=1320)</span> <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="top">   Libido decreased <br/> </td><td align="center" class="Rrule" valign="top">4% <br/> </td><td align="center" class="Rrule" valign="top">2% <br/> </td> </tr> </tbody> </table></div>

Adverse Reactions in Pediatric Patients In 281 pediatric patients treated with sertraline hydrochloride in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety. Other Adverse Reactions Observed During the Premarketing Evaluation of Sertraline Hydrochloride

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with sertraline hydrochloride were: Cardiac disorders  - tachycardia Ear and labyrinth disorders  - tinnitus Endocrine disorders - hypothyroidism Eye disorders - mydriasis, blurred vision Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia Hepatobiliary disorders - elevated liver enzymes Immune system disorders - anaphylaxis Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite Musculoskeletal and connective tissue disorders  - arthralgia, muscle spasms, tightness, or twitching Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination Renal and urinary disorders - hematuria Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria Vascular disorders - hemorrhage, hypertension, vasodilation

The following adverse reactions have been identified during postapproval use of sertraline hydrochloride. 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. Bleeding or clotting disorders - increased coagulation times (altered platelet function) Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [See Clinical Pharmacology (12.2)]   Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH Eye disorders - blindness, optic neuritis, cataract Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness Immune system disorders - angioedema Metabolism and nutrition disorders - hyponatremia, hyperglycemia Musculoskeletal and connective tissue disorders- rhabdomyolysis, trismus Nervous system disorders- serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis Psychiatric disorders – psychosis, enuresis, paroniria Renal and urinary disorders - acute renal failure Respiratory, thoracic and mediastinal  disorders- pulmonary hypertension, eosinophilic pneumonia, anosmia, hyposmia Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

Table 5 includes clinically significant drug interactions with sertraline hydrochloride [See Clinical Pharmacology (12.3)] . 

<div class="scrollingtable"><table border="0" cellpadding="0" cellspacing="0" width="100%"> <caption> <span>Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride</span> </caption> <col width="16.28%"/> <col width="83.72%"/> <tbody class="Headless"> <tr class="Botrule First"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Monoamine Oxidase Inhibitors (MAOIs) </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue <span class="Italics">[See <a href="#Section_2.5">Dosage and Administration (2.5)</a>, <a href="#Section_4">Contraindications (4)</a>, <a href="#Section_5.2">Warnings and Precautions (5.2)</a>]. </span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="top"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Pimozide </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">Concomitant use of pimozide and sertraline hydrochloride is contraindicated <span class="Italics">[See <a href="#Section_4">Contraindications (4)</a>]. </span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Other Serotonergic Drugs </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">The concomitant use of serotonergic drugs with sertraline hydrochloride increases the risk of serotonin syndrome. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of sertraline hydrochloride and/or concomitant serotonergic drugs <span class="Italics">[See <a href="#Section_5.2">Warnings and Precautions (5.2)</a>]. </span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">The concurrent use of an antiplatelet agent or anticoagulant with sertraline hydrochloride may potentiate the risk of bleeding. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio <span class="Italics">[See <a href="#Section_5.3">Warnings and Precautions (5.3)</a>]. </span> <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">aspirin, clopidogrel, heparin, warfarin <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Drugs Highly Bound to Plasma Protein </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline hydrochloride is highly bound to plasma protein. The concomitant use of sertraline hydrochloride with another drug that is highly bound to plasma protein may increase free concentrations of sertraline hydrochloride or other tightly-bound drugs in plasma <span class="Italics">[See <a href="#Section_12.3">Clinical Pharmacology (12.3)</a>] </span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">warfarin <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Drugs Metabolized by CYP2D6 </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Sertraline hydrochloride is a CYP2D6 inhibitor <span class="Italics">[See <a href="#Section_12.3">Clinical Pharmacology (12.3)</a>] </span>. The concomitant use of sertraline hydrochloride with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Decrease the dosage of a CYP2D6 substrate if needed with concomitant sertraline hydrochloride use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride is discontinued. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="top">propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Phenytoin </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Phenytoin is a narrow therapeutic index drug. Sertraline hydrochloride may increase phenytoin concentrations. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span> <br/> </td><td align="justify" class="Rrule" valign="top">Monitor phenytoin levels when initiating or titrating sertraline hydrochloride. Reduce phenytoin dosage if needed. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">phenytoin, fosphenytoin <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" colspan="2" valign="middle"><span class="Bold"> <br/> Drugs that Prolong the QTc Interval </span></td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span><span class="Italics"></span> <br/> </td><td align="justify" class="Rrule" valign="middle">The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of other drugs which prolong the QTc interval <span class="Italics">[See <a href="#Section_5.10">Warnings and Precautions (5.10)</a>, <a href="#Section_12.2">Clinical Pharmacology (12.2)</a>] </span>. <br/> </td> </tr> <tr class="Botrule"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Intervention:</span><span class="Italics"></span> <br/> </td><td align="justify" class="Rrule" valign="middle">Pimozide is contraindicated for use with sertraline. Avoid the concomitant use of drugs known to prolong the QTc interval. <br/> </td> </tr> <tr class="Last"> <td class="Lrule Rrule" valign="middle"><span class="Italics">Examples:</span> <br/> </td><td align="justify" class="Rrule" valign="middle">Specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). <br/> </td> </tr> </tbody> </table></div>

Based on pharmacokinetic studies, no dosage adjustment of sertraline hydrochloride is necessary when used in combination with cimetidine. Additionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when sertraline hydrochloride is administered concomitantly [See Clinical Pharmacology (12.3)] .

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline hydrochloride. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline hydrochloride. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

Risk Summary

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see  Warnings and Precautions (5.3)and Clinical Considerations] . Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data]. There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including sertraline hydrochloride, during the third trimester of pregnancy [See Clinical Considerations].

Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times the MRHD in rabbits on a mg/m 2basis in adolescents. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD [See Data].

The background risk of major birth defects and miscarriage for the indicated population are 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. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride. Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of sertraline hydrochloride in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3)].

Fetal/Neonatal adverse reactions

Exposure to SSRIs and SNRIs, including sertraline hydrochloride in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

When treating a pregnant woman with sertraline hydrochloride during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to sertraline hydrochloride in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [See Data].

Data

Human Data

Third Trimester Exposure

Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [See Warnings and Precautions (5.2)] .

Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20 thweek of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997 to 2005 found a PPHN risk ratio of 2.4 (95% CI 1.2 to 4.3) associated with patient-reported maternal use of SSRIs “in early pregnancy” and a PPHN risk ratio of 3.6 (95% CI 1.2 to 8.3) associated with a combination of patient-reported maternal use of SSRIs “in early pregnancy” and an antenatal SSRI prescription “in later pregnancy”.

First Trimester Exposure

The weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline. A meta-analysis of studies suggest no increase in the risk of total malformations (summary odds ratio=1.01, 95% CI=0.88 to 1.17) or cardiac malformations (summary odds ratio=0.93, 95% CI=0.70 to 1.23) among offspring of women with first trimester exposure to sertraline. An increased risk of congenital cardiac defects, specifically septal defects, the most common type of congenital heart defect, was observed in some published epidemiologic studies with first trimester sertraline exposure; however, most of these studies were limited by the use of comparison populations that did not allow for the control of confounders such as the underlying depression and associated conditions and behaviors, which may be factors associated with increased risk of these malformations. Animal Data  

Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 3.1 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m 2basis in adolescents. There was no evidence of teratogenicity at any dose level. When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.4 times the MRHD on a mg/m 2basis) in rats and 40 mg/kg (3.1 times the MRHD on a mg/m 2basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in stillborn pups and pup deaths during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (0.8 times the MRHD on a mg/m 2basis). The no effect dose for rat pup mortality was 10 mg/kg (0.4 times the MRHD on a mg/m 2basis). The decrease in pup survival was shown to be due to in uteroexposure to sertraline. The clinical significance of these effects is unknown.

Risk Summary Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data]. There are no data on the effects of sertraline on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sertraline hydrochloride and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Data In a published pooled analysis of 53 mother-infant pairs, exclusively human milk-fed infants had an average of 2% (range 0% to 15%) of the sertraline serum levels measured in their mothers. No adverse reactions were observed in these infants.

The safety and efficacy of sertraline hydrochloride have been established in the treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)] . Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients. Monitoring Pediatric Patients Treated with Sertraline Hydrochloride Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [See Boxed Warning, Warnings and Precautions (5.1)] . Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with an SSRI such as sertraline hydrochloride. Weight Loss in Studies in Pediatric Patients with MDD In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for MDD (n=373), there was a difference in weight change between sertraline hydrochloride and placebo of roughly 1 kg, for both children (ages 6 to 11) and adolescents (ages 12 to 17), in both age groups representing a slight weight loss for the sertraline hydrochloride group compared to a slight gain for the placebo group. For children, about 7% of the sertraline hydrochloride-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for adolescents, about 2% of sertraline hydrochloride-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients. A subset of patients who completed the randomized controlled trials in patients with MDD (sertraline hydrochloride n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. Those subjects who completed 34 weeks of sertraline hydrochloride treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. However, there are no studies that directly evaluate the long-term effects of sertraline hydrochloride on the growth, development, and maturation in pediatric patients. Juvenile Animal Data A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females. In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period. The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

Of the total number of patients in clinical studies of sertraline hydrochloride in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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 conservative, 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 drug therapy. In 354 geriatric subjects treated with sertraline hydrochloride in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 3 [See Adverse Reactions (6.1)], except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients. SNRIs and SSRIs, including sertraline hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [SeeWarnings and Precautions (5.8)].

The recommended dosage in patients with mild hepatic impairment (Child-Pugh score 5 or 6) is half the recommended dosage due to increased exposure in this patient population. The use of sertraline hydrochloride in patients with moderate (Child-Pugh score 7 to 10) or severe hepatic impairment (Child-Pugh score 10 to 15) is not recommended, because sertraline hydrochloride is extensively metabolized, and the effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied [See Dosage and Administration (2.4), Clinical Pharmacology (12.3)] .

No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment [See Clinical Pharmacology (12.3)] .

Sertraline hydrochloride tablets contain sertraline, which is not a controlled substance.

In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.

The following have been reported with sertraline tablet overdosage:

{ "type": "p", "children": [], "text": "The following have been reported with sertraline tablet overdosage:" }

{ "type": "ul", "children": [ "Seizures, which may be delayed, and altered mental status including coma.", "Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.", "Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk)." ], "text": "" }

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

{ "type": "p", "children": [], "text": "Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations." }

Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2•HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C\n \n 17H\n \n 17NCl\n \n 2•HCl is represented by the following structural formula: \n \n\n\n Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. \n \n Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. \n \n Meets USP dissolution test 3.\n\n " }

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitrostudies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitrostudies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors. The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors. Sertraline does not inhibit monoamine oxidase. Alcohol In healthy subjects, the acute cognitive and psychomotor effects of alcohol were not potentiated by sertraline hydrochloride. Cardiac Electrophysiology

The effect of sertraline on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects. At 2-fold the maximum recommended daily dose (~3-fold the steady-state exposure for sertraline and N-desmethylsertraline), the largest mean ΔΔQTc was 10 ms with upper bound of two-sided 90% confidence interval of 12 ms. The length of the QTc interval was also positively correlated with serum concentrations of sertraline and N-desmethylsertraline concentrations. These concentration-based analyses, however, indicated a lesser effect on QTc at maximally observed concentration than in the primary analysis [See Warnings and Precautions (5), Adverse Reactions (6), Drug Interactions (7), Overdosage (10)] .

Absorption Following oral once-daily sertraline hydrochloride dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (C max) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing. Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the C maxand area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. The single dose bioavailability of sertraline hydrochloride tablets is approximately equal to an equivalent dose of sertraline hydrochloride oral solution. Administration with food causes a small increase in C maxand AUC. Metabolism Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation. N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitrobiochemical and in vivopharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline. Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40 to 45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40 to 45% of the administered radioactivity was accounted for in feces, including 12 to 14% unchanged sertraline. Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0 to 24-hour), C maxand C min, with about a 5- to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14. Protein Binding In vitro protein binding studies performed with radiolabeled 3H-sertraline showed that sertraline is highly bound to serum proteins (98%) in the range of 20 to 500 ng/mL. However, at up to 300 and 200 ng/mL concentrations, respectively, sertraline and N-desmethylsertraline did not alter the plasma protein binding of two other highly protein bound drugs, warfarin and propranolol. Studies in Specific Populations Pediatric Patients Sertraline pharmacokinetics were evaluated in a group of 61 pediatric patients (29 aged 6 to 12 years, 32 aged 13 to 17 years) including both males (N=28) and females (N=33). Relative to the adults, pediatric patients aged 6 to 12 years and 13 to 17 years showed about 22% lower AUC (0 to 24 hr) and C maxvalues when plasma concentration was adjusted for weight. The half-life was similar to that in adults, and no gender-associated differences were observed [See Dosage and Administration (2.1), Use in Specific Populations (8.4)] . Geriatric Patients Sertraline plasma clearance in a group of 16 (8 male, 8 female) elderly patients treated with 100 mg/day of sertraline hydrochloride for 14 days was approximately 40% lower than in a similarly studied group of younger (25 to 32 year old) individuals. Steady-state, therefore, was achieved after 2 to 3 weeks in older patients. The same study showed a decreased clearance of desmethylsertraline in older males, but not in older females [See Use in Specific Populations (8.5)] . Hepatic Impairment In patients with chronic mild liver impairment (N=10: 8 patients with Child-Pugh scores of 5 to 6; and 2 patients with Child-Pugh scores of 7 to 8) who received 50 mg of sertraline hydrochloride per day for 21 days, sertraline clearance was reduced, resulting in approximately 3-fold greater exposure compared to age-matched volunteers with normal hepatic function (N=10). The exposure to desmethylsertraline was approximately 2-fold greater in patients with mild hepatic impairment compared to age-matched volunteers with normal hepatic function. There were no significant differences in plasma protein binding observed between the two groups. The effects of sertraline hydrochloride in patients with moderate and severe hepatic impairment have not been studied [See Dosage and Administration (2.4), Use in Specific Populations (8.6)] . Renal Impairment Sertraline is extensively metabolized and excretion of unchanged drug in urine is a minor route of elimination. In volunteers with mild to moderate (CLcr=30 to 60 mL/min), moderate to severe (CLcr=10 to 29 mL/min) or severe (receiving hemodialysis) renal impairment (N=10 each group), the pharmacokinetics and protein binding of 200 mg sertraline per day maintained for 21 days were not altered compared to age-matched volunteers (N=12) with no renal impairment. Thus sertraline multiple dose pharmacokinetics appear to be unaffected by renal impairment [See Use in Specific Populations (8.7)] . Drug Interaction Studies Pimozide In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline hydrochloride (once daily) co-administration to steady state was associated with a mean increase in pimozide AUC and C maxof about 40%, but was not associated with any changes in ECG. The highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline hydrochloride. The effect on QTc interval and PK parameters at doses higher than 2 mg of pimozide are not known [See Drug Interactions (7.1)] . Drugs Metabolized by CYP2D6 Many antidepressant drugs (e.g., SSRIs, including sertraline hydrochloride, and most tricyclic antidepressant drugs) inhibit the biochemical activity of the drug metabolizing isozyme CYP2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by CYP2D6. The drugs for which this potential interaction is of greatest concern are those metabolized primarily by CYP2D6 and that have a narrow therapeutic index (e.g., tricyclic antidepressant drugs and the Type 1C antiarrhythmics propafenone and flecainide). The extent to which this interaction is an important clinical problem depends on the extent of the inhibition of CYP2D6 by the antidepressant and the therapeutic index of the co-administered drug. There is variability among the drugs effective in the treatment of MDD in the extent of clinically important 2D6 inhibition, and in fact sertraline hydrochloride at lower doses has a less prominent inhibitory effect on 2D6 than some others in the class. Nevertheless, even sertraline hydrochloride has the potential for clinically important 2D6 inhibition [See Drug Interactions (7.1)] . Phenytoin Clinical trial data suggested that sertraline hydrochloride may increase phenytoin concentrations [See Drug Interactions (7.1)] . Cimetidine In a study assessing disposition of sertraline hydrochloride (100 mg) on the second of 8 days of cimetidine administration (800 mg daily), there were increases in sertraline hydrochloride mean AUC (50%), C max(24%) and half-life (26%) compared to the placebo group [See Drug Interactions (7.2)] . Diazepam In a study comparing the disposition of intravenously administered diazepam before and after 21 days of dosing with either sertraline hydrochloride (50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the sertraline hydrochloride group compared to a 19% decrease relative to baseline for the placebo group (p<0.03). There was a 23% increase in T maxfor desmethyldiazepam in the sertraline hydrochloride group compared to a 20% decrease in the placebo group (p<0.03) [See Drug Interactions (7.2)] . Lithium In a placebo-controlled trial in normal volunteers, the administration of two doses of sertraline hydrochloride did not significantly alter steady-state lithium levels or the renal clearance of lithium [See Drug Interactions (7.2)] . Tolbutamide In a placebo-controlled trial in normal volunteers, administration of sertraline hydrochloride for 22 days (including 200 mg/day for the final 13 days) caused a statistically significant 16% decrease from baseline in the clearance of tolbutamide following an intravenous 1000 mg dose. Sertraline hydrochloride administration did not noticeably change either the plasma protein binding or the apparent volume of distribution of tolbutamide, suggesting that the decreased clearance was due to a change in the metabolism of the drug [See Drug Interactions (7.2)] . Atenolol Sertraline hydrochloride (100 mg) when administered to 10 healthy male subjects had no effect on the beta-adrenergic blocking ability of atenolol [See Drug Interactions (7.2)] . Digoxin In a placebo-controlled trial in normal volunteers, administration of sertraline hydrochloride for 17 days (including 200 mg/day for the last 10 days) did not change serum digoxin levels or digoxin renal clearance [See Drug Interactions (7.2)] . Drugs Metabolized by CYP3A4 In three separate in vivointeraction studies, sertraline hydrochloride was co-administered with CYP3A4 substrates, terfenadine, carbamazepine, or cisapride under steady-state conditions. The results of these studies indicated that sertraline hydrochloride did not increase plasma concentrations of terfenadine, carbamazepine, or cisapride. These data indicate that sertraline hydrochloride’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance. Results of the interaction study with cisapride indicate that sertraline hydrochloride 200 mg (once daily) induces the metabolism of cisapride (cisapride AUC and C maxwere reduced by about 35%) [See Drug Interactions (7.2)] . Microsomal Enzyme Induction Preclinical studies have shown sertraline hydrochloride to induce hepatic microsomal enzymes. In clinical studies, sertraline hydrochloride was shown to induce hepatic enzymes minimally as determined by a small (5%) but statistically significant decrease in antipyrine half-life following administration of 200 mg of sertraline hydrochloride per day for 21 days. This small change in antipyrine half-life reflects a clinically insignificant change in hepatic metabolism.

Carcinogenesis Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/day. These doses correspond to 1 times (mice) and 2 times (rats) the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m 2basis. There was a dose-related increase of liver adenomas in male mice receiving sertraline at 10 to 40 mg/kg (0.25 to 1.0 times the MRHD on a mg/m 2basis). No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg (2 times the MRHD on a mg/m 2basis); this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10 to 40 mg/kg (0.5 to 2.0 times the MRHD on a mg/m 2basis) compared to placebo controls, this effect was not clearly drug related. Mutagenesis Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays: bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in vivoin mouse bone marrow and in vitroin human lymphocytes. Impairment of Fertility A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (3.1 times the maximum recommended human dose on a mg/m 2basis in adolescents).

The efficacy of sertraline hydrochloride as a treatment for MDD was established in two randomized, double-blind, placebo-controlled studies and one double-blind, randomized-withdrawal study following an open label study in adult (ages 18 to 65) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) criteria for MDD (studies MDD-1 and MDD-2).

Overall, these studies demonstrated sertraline hydrochloride to be superior to placebo on the Hamilton Rating Scale for Depression (HAMD-17) and the Clinical Global Impression Severity (CGI-S) of Illness and Global Improvement (CGI-I) scores. Study MDD-2 was not readily interpretable regarding a dose response relationship for effectiveness. A third study (Study MDD-3) involved adult outpatients meeting the DSM-III criteria for MDD who had responded by the end of an initial 8-week open treatment phase on sertraline hydrochloride 50 to 200 mg/day. These patients (n=295) were randomized to continuation on double-blind sertraline hydrochloride 50 to 200 mg/day or placebo for 44 weeks. A statistically significantly lower relapse rate was observed for patients taking sertraline hydrochloride compared to those on placebo: sertraline hydrochloride [n=11 (8%)] and placebo [n=31 (39%)]. The mean sertraline hydrochloride dose for completers was 70 mg/day. Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.

Adults with OCD The effectiveness of sertraline hydrochloride in the treatment of OCD was demonstrated in three multicenter placebo-controlled studies of adult (age 18 to 65) non-depressed outpatients (Studies OCD-1, OCD-2, and OCD-3). Patients in all three studies had moderate to severe OCD (DSM-III or DSM-III-R) with mean baseline ratings on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score ranging from 23 to 25.  

Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex. The effectiveness of sertraline hydrochloride tablets were studied in the risk reduction of OCD relapse. In Study OCD-4, patients ranging in age from 18 to 79 meeting DSM-III-R criteria for OCD who had responded during a 52-week single-blind trial on sertraline hydrochloride 50 to 200 mg/day (n=224) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for analysis of discontinuation due to relapse or insufficient clinical response. Response during the single-blind phase was defined as a decrease in the Y-BOCS score of ≥ 25% compared to baseline and a CGI-I of 1 (very much improved), 2 (much improved) or 3 (minimally improved). Insufficient clinical response during the double-blind phase indicated a worsening of the patient’s condition that resulted in study discontinuation, as assessed by the investigator. Relapse during the double-blind phase was defined as the following conditions being met (on three consecutive visits for 1 and 2, and condition 3 being met at visit 3):  

Patients receiving continued sertraline hydrochloride treatment experienced a statistically significantly lower rate of discontinuation due to relapse or insufficient clinical response over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects. Pediatric Patients with OCD The effectiveness of sertraline hydrochloride for the treatment of OCD was demonstrated in a 12-week, multicenter, placebo-controlled, parallel group study in a pediatric outpatient population (ages 6-17) (Study OCD-5). Sertraline hydrochloride (N=92) was initiated at doses of either 25 mg/day (pediatric patients ages 6 to 12) or 50 mg/day (adolescents, ages 13 to 17), and then titrated at 3 and 4 day intervals (25 mg incremental dose for pediatric patients ages 6 to 12) or 1 week intervals (50 mg incremental dose adolescents ages 13 to 17) over the next four weeks to a maximum dose of 200 mg/day, as tolerated. The mean dose for completers was 178 mg/day. Dosing was once a day in the morning or evening. Patients in this study had moderate to severe OCD (DSM-III-R) with mean baseline ratings on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score of 22. Patients receiving sertraline hydrochloride experienced a mean reduction of approximately 7 units on the CY-BOCS total score which was statistically significantly greater than the 3 unit reduction for placebo patients (n=95). Analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.

The effectiveness of sertraline hydrochloride in the treatment of PD was demonstrated in three double-blind, placebo-controlled studies (Studies PD-1, PD-2, and PD-3) of adult outpatients who had a primary diagnosis of PD (DSM-III-R), with or without agoraphobia.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age, race, or gender.

In Study PD-4, patients meeting DSM-III-R criteria for PD who had responded during a 52-week open trial on sertraline hydrochloride 50 to 200 mg/day (n=183) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for discontinuation due to relapse or insufficient clinical response. Response during the open phase was defined as a CGI-I score of 1(very much improved) or 2 (much improved). Insufficient clinical response in the double-blind phase indicated a worsening of the patient’s condition that resulted in study discontinuation, as assessed by the investigator. Relapse during the double-blind phase was defined as the following conditions being met on three consecutive visits:

(1) CGI-I ≥ 3; (2) meets DSM-III-R criteria for PD; (3) number of panic attacks greater than at baseline.

Patients receiving continued sertraline hydrochloride treatment experienced a statistically significantly lower rate of discontinuation due to relapse or insufficient clinical response over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

The effectiveness of sertraline hydrochloride in the treatment of PTSD was established in two multicenter placebo-controlled studies (Studies PSTD-1 and PSTD-2) of adult outpatients who met DSM-III-R criteria for PTSD. The mean duration of PTSD for these patients was 12 years (Studies PSTD-1 and PSTD-2 combined) and 44% of patients (169 of the 385 patients treated) had secondary depressive disorder. Studies PSTD-1 and PSTD-2 were 12-week flexible dose studies. Sertraline hydrochloride was initiated at 25 mg/day for the first week, and titrated in weekly increments of 50 mg per day to a maximum dose of 200 mg/day on the basis of clinical response and tolerability. The mean sertraline hydrochloride dose for completers was 146 mg/day and 151 mg/day, respectively, for Studies PSTD-1 and PSTD-2. Study outcome was assessed by the Clinician-Administered PTSD Scale Part 2 (CAPS), which is a multi-item instrument that measures the three PTSD diagnostic symptom clusters of reexperiencing/intrusion, avoidance/numbing, and hyperarousal as well as the patient-rated Impact of Event Scale (IES), which measures intrusion and avoidance symptoms. Patients receiving sertraline hydrochloride (N=99 and N=94, respectively) showed statistically significant improvement compared to placebo (N=83 and N=92) on change from baseline to endpoint on the CAPS, IES, and on the Clinical Global Impressions (CGI-S) Severity of Illness and Global Improvement (CGI-I) scores. In two additional placebo-controlled PTSD trials (Studies PSTD-3 and PSTD-4), the difference in response to treatment between patients receiving sertraline hydrochloride and patients receiving placebo was not statistically significant. One of these additional studies was conducted in patients similar to those recruited for Studies PSTD-1 and PSTD-2, while the second additional study was conducted in predominantly male veterans. As PTSD is a more common disorder in women than men, the majority (76%) of patients in Studies PSTD-1 and PSTD-2 described above were women. Post hoc exploratory analyses revealed a statistically significant difference between sertraline hydrochloride and placebo on the CAPS, IES and CGI in women, regardless of baseline diagnosis of comorbid major depressive disorder, but essentially no effect in the relatively smaller number of men in these studies. The clinical significance of this apparent gender effect is unknown at this time. There was insufficient information to determine the effect of race or age on outcome. In Study PSTD-5, patients meeting DSM-III-R criteria for PTSD who had responded during a 24-week open trial on sertraline hydrochloride 50 to 200 mg/day (n=96) were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 28 weeks of observation for relapse. Response during the open phase was defined as a CGI-I of 1 (very much improved) or 2 (much improved), and a decrease in the CAPS-2 score of > 30% compared to baseline. Relapse during the double-blind phase was defined as the following conditions being met on two consecutive visits:

(1) CGI-I ≥ 3; (2) CAPS-2 score increased by ≥ 30% and by ≥ 15 points relative to baseline; and (3) worsening of the patient's condition in the investigator's judgment.

Patients receiving continued sertraline hydrochloride treatment experienced statistically significantly lower relapse rates over the subsequent 28 weeks compared to those receiving placebo. This pattern was demonstrated in male and female subjects.

The effectiveness of sertraline hydrochloride in the treatment of SAD (also known as social phobia) was established in two multicenter, randomized, placebo-controlled studies (Study SAD-1 and SAD-2) of adult outpatients who met DSM-­IV criteria for SAD. Study SAD-1 was a 12-week, flexible dose study comparing sertraline hydrochloride (50 to 200 mg/day), n=211, to placebo, n=204, in which sertraline hydrochloride was initiated at 25 mg/day for the first week, then titrated to the maximum tolerated dose in 50 mg increments biweekly. Study outcomes were assessed by the:

(1)  Liebowitz Social Anxiety Scale (LSAS), a 24-item clinician administered instrument that measures fear, anxiety, and avoidance of social and performance situations, and (2)  Proportion of responders as defined by the Clinical Global Impression of Improvement (CGI-I) criterion of CGI-I ≤ 2 (very much or much improved).

Sertraline hydrochloride was statistically significantly more effective than placebo as measured by the LSAS and the percentage of responders. Study SAD-2 was a 20-week, flexible dose study that compared sertraline hydrochloride (50 to 200 mg/day), n=135, to placebo, n=69. Sertraline hydrochloride was titrated to the maximum tolerated dose in 50 mg increments every 3 weeks. Study outcome was assessed by the:

(1)  Duke Brief Social Phobia Scale (BSPS), a multi-item clinician-rated instrument that measures fear, avoidance and physiologic response to social or performance situations, (2)  Marks Fear Questionnaire Social Phobia Subscale (FQ-SPS), a 5-item patient-rated instrument that measures change in the severity of phobic avoidance and distress, and (3)  CGI-I responder criterion of ≤ 2.

Sertraline hydrochloride was shown to be statistically significantly more effective than placebo as measured by the BSPS total score and fear, avoidance and physiologic factor scores, as well as the FQ-SPS total score, and to have statistically significantly more responders than placebo as defined by the CGI-I. Subgroup analyses did not suggest differences in treatment outcome on the basis of gender. There was insufficient information to determine the effect of race or age on outcome. In Study SAD-3, patients meeting DSM-IV criteria for SAD who had responded while assigned to sertraline hydrochloride (CGI-I of 1 or 2) during a 20-week placebo-controlled trial on sertraline hydrochloride 50 to 200 mg/day were randomized to continuation of sertraline hydrochloride or to substitution of placebo for up to 24 weeks of observation for relapse. Relapse was defined as ≥ 2 point increase in the Clinical Global Impression Severity of Illness (CGI-S) score compared to baseline or study discontinuation due to lack of efficacy. Patients receiving sertraline hydrochloride continuation treatment experienced a statistically significantly lower relapse rate during this 24-week period than patients randomized to placebo substitution.

The effectiveness of sertraline hydrochloride for the treatment of PMDD was established in two double-blind, parallel group, placebo-controlled flexible dose trials (Studies PMDD-1 and PMDD-2) conducted over 3 menstrual cycles in adult female patients. The effectiveness of sertraline hydrochloride for PMDD for more than 3 menstrual cycles has not been systematically evaluated in controlled trials. Patients in Study PMDD-1 met DSM-III-R criteria for Late Luteal Phase Dysphoric Disorder (LLPDD), the clinical entity referred to as PMDD in DSM-IV. Patients in Study PMDD-2 met DSM-IV criteria for PMDD. Study PMDD-1 utilized continuous daily dosing throughout the study, while Study PMDD-2 utilized luteal phase dosing (intermittent dosing) for the 2 weeks prior to the onset of menses. The mean duration of PMDD symptoms was approximately 10.5 years in both studies. Patients taking oral contraceptives were excluded from these trials; therefore, the efficacy of sertraline hydrochloride in combination with oral contraceptives for the treatment of PMDD is unknown. Efficacy was assessed with the Daily Record of Severity of Problems (DRSP), a patient-rated instrument that mirrors the diagnostic criteria for PMDD as identified in the DSM-IV, and includes assessments for mood, physical symptoms, and other symptoms. Other efficacy assessments included the Hamilton Rating Scale for Depression (HAMD-17), and the Clinical Global Impression Severity of Illness (CGI-S) and Improvement (CGI-I) scores.

There was insufficient information to determine the effect of race or age on outcome in these studies.

Sertraline Hydrochloride Tablets USP, 100 mg are yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side.

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NDC: 70518-2448-00

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NDC: 70518-2448-01

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NDC: 70518-2448-02

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NDC: 70518-2448-03

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NDC: 70518-2448-04

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NDC: 70518-2448-05

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NDC: 70518-2448-06

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NDC: 70518-2448-07

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PACKAGING: 30 in 1 BLISTER PACK

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PACKAGING: 90 in 1 BOTTLE PLASTIC

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PACKAGING: 28 in 1 BLISTER PACK

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PACKAGING: 90 in 1 BOTTLE PLASTIC

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PACKAGING: 60 in 1 BOTTLE PLASTIC

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PACKAGING: 30 in 1 BLISTER PACK

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PACKAGING: 30 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BLISTER PACK" }

PACKAGING: 30 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BOTTLE PLASTIC " }

Store Sertraline Hydrochloride Tablets USP at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].

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Repackaged and Distributed By:

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Remedy Repack, Inc.

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625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

{ "type": "p", "children": [], "text": "625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762" }

Advise the patient to read the FDA-approved patient labeling ( Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warningand Warnings and Precautions (5.1)] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [SeeWarnings and Precautions (5.2), Drug Interactions (7.1)] . Increased Risk of Bleeding Inform patients about the concomitant use of sertraline hydrochloride with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-­counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3)]. Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4)] . Discontinuation Syndrome Advise patients not to abruptly discontinue sertraline hydrochloride and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride is discontinued [SeeWarnings and Precautions (5.5)]. Sexual Dysfunction Advise patients that use of sertraline hydrochloride may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11)]. Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2)] . Pregnancy Inform pregnant women that sertraline hydrochloride may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1)] . Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride during pregnancy.

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling ( \n Medication Guide).\n \n\nSuicidal Thoughts and Behaviors \n\n\nAdvise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider \n [See \n Boxed Warningand \n Warnings and Precautions (5.1)] \n . \n \n\nSerotonin Syndrome \n\n\nCaution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome \n [SeeWarnings and Precautions (5.2), \n Drug Interactions (7.1)] \n . \n \n\nIncreased Risk of Bleeding \n\n\nInform patients about the concomitant use of sertraline hydrochloride with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-­counter medications that increase the risk of bleeding \n [See \n Warnings and Precautions (5.3)]. \n \n\n\nActivation of Mania/Hypomania \n\n\nAdvise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider \n [See \n Warnings and Precautions (5.4)] \n .\n \n\nDiscontinuation Syndrome \n\n\nAdvise patients not to abruptly discontinue sertraline hydrochloride and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride is discontinued \n [SeeWarnings and Precautions (5.5)]. \n\n\nSexual Dysfunction \n\n\nAdvise patients that use of sertraline hydrochloride may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider \n [see \n Warnings and Precautions (5.11)]. \n \n\n\nAllergic Reactions \n\n\nAdvise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing \n [See \n Adverse Reactions (6.2)] \n .\n \n\nPregnancy \n\n\nInform pregnant women that sertraline hydrochloride may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) \n [See \n Use in Specific Populations (8.1)] \n . Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride during pregnancy.\n \n" }

Repackaged By / Distributed By: RemedyRepack Inc.

{ "type": "p", "children": [], "text": "Repackaged By / Distributed By: RemedyRepack Inc." }

625 Kolter Drive, Indiana, PA 15701

{ "type": "p", "children": [], "text": "625 Kolter Drive, Indiana, PA 15701" }

(724) 465-8762

{ "type": "p", "children": [], "text": "(724) 465-8762" }

Sertraline Hydrochloride Tablets USP (ser' tra leen hye'' droe klor' ide) What is the most important information I should know about sertraline hydrochloride tablets?

{ "type": "p", "children": [], "text": "\nSertraline Hydrochloride Tablets USP \n\n(ser' tra leen hye'' droe klor' ide)\n\n\nWhat is the most important information I should know about sertraline hydrochloride tablets?\n" }

Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.

{ "type": "p", "children": [], "text": "\nSertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.\n" }

1. Suicidal thoughts or actions:

{ "type": "p", "children": [], "text": "\n1. Suicidal thoughts or actions:\n" }

{ "type": "ul", "children": [ "\nSertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actionsin some people 24 years of age and younger, especially within the \n first few months of treatment or when the dose is changed.\n ", "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.", "Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.\n\t\n \nPay particular attention to such changes when sertraline hydrochloride tablets is started or when the dose is changed.\nKeep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. \n\n" ], "text": "" }

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

{ "type": "p", "children": [], "text": "\nCall your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:\n" }

{ "type": "ul", "children": [ "attempts to commit suicide", "acting aggressive or violent", "new or worse depression", "feeling agitated, restless, angry or irritable", "an increase in activity or talking more than what is normal for you", "acting on dangerous impulses", "thoughts about suicide or dying", "new or worse anxiety or panic attacks", "trouble sleeping", "other unusual changes in behavior or mood " ], "text": "" }

2. Serotonin Syndrome.This condition can be life-threatening and symptoms may include:

{ "type": "p", "children": [], "text": "\n2. Serotonin Syndrome.This condition can be life-threatening and symptoms may include: \n " }

{ "type": "ul", "children": [ "agitation, hallucinations, coma, or other changes in mental status", "racing heartbeat, high or low blood pressure", "coordination problems or muscle twitching (overactive reflexes)", "nausea, vomiting, or diarrhea", "sweating or fever", "muscle rigidity " ], "text": "" }

3. Increased chance of bleeding: Sertraline hydrochloride tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ®, Jantoven ®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

{ "type": "p", "children": [], "text": "\n3. Increased chance of bleeding: Sertraline hydrochloride tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin \n ®, Jantoven \n ®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.\n " }

4. Manic episodes.Symptoms may include:

{ "type": "p", "children": [], "text": "\n4. Manic episodes.Symptoms may include: \n " }

{ "type": "ul", "children": [ "greatly increased energy", "racing thoughts", "unusually grand ideas", "severe trouble sleeping", "reckless behavior", "excessive happiness or irritability ", "talking more or faster than usual " ], "text": "" }

5. Seizures or convulsions.

{ "type": "p", "children": [], "text": "\n5. Seizures or convulsions.\n" }

6. Glaucoma (angle-closure glaucoma).Many antidepressant medicines including sertraline hydrochloride tablets may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

{ "type": "p", "children": [], "text": "\n6. Glaucoma (angle-closure glaucoma).Many antidepressant medicines including sertraline hydrochloride tablets may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.\n " }

7. Changes in appetite or weight.Children and adolescents should have height and weight monitored during treatment.

{ "type": "p", "children": [], "text": "\n7. Changes in appetite or weight.Children and adolescents should have height and weight monitored during treatment.\n " }

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

{ "type": "p", "children": [], "text": "\n8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include: \n " }

{ "type": "ul", "children": [ "headache", "weakness or feeling unsteady", "confusion, problems concentrating or thinking, or memory problems " ], "text": "" }

9. Sexual problems (dysfunction).Taking selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride tablets, may cause sexual problems.

{ "type": "p", "children": [], "text": "\n9. Sexual problems (dysfunction).Taking selective serotonin reuptake inhibitors (SSRIs), including sertraline hydrochloride tablets, may cause sexual problems.\n " }

Symptoms in males may include:

{ "type": "p", "children": [], "text": " Symptoms in males may include:" }

{ "type": "ul", "children": [ "Delayed ejaculation or inability to have an ejaculation", "Decreased sex drive", "Problems getting or keeping an erection" ], "text": "" }

Symptoms in females may include:

{ "type": "p", "children": [], "text": " Symptoms in females may include:" }

{ "type": "ul", "children": [ "Decreased sex drive", "Delayed orgasm or inability to have an orgasm" ], "text": "" }

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydrochloride tablets. There may be treatments your healthcare provider can suggest.

{ "type": "p", "children": [], "text": "Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydrochloride tablets. There may be treatments your healthcare provider can suggest." }

Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider.Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:

{ "type": "p", "children": [], "text": "\n\nDo not stop sertraline hydrochloride tablets without first talking to your healthcare provider.Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including:\n " }

{ "type": "ul", "children": [ "anxiety, irritability, high or low mood, feeling restless or changes in sleep habits", "headache, sweating, nausea, dizziness", "electric shock-like sensations, shaking, confusion" ], "text": "" }

What are sertraline hydrochloride tablets? Sertraline hydrochloride tablets are a prescription medicine used to treat:

{ "type": "p", "children": [], "text": "\nWhat are sertraline hydrochloride tablets? \n\n\nSertraline hydrochloride tablets are a prescription medicine used to treat: \n " }

{ "type": "ul", "children": [ "Major Depressive Disorder (MDD)", "Panic Disorder", "Social Anxiety Disorder", "Obsessive Compulsive Disorder (OCD)", "Posttraumatic Stress Disorder (PTSD)", "Premenstrual Dysphoric Disorder (PMDD) " ], "text": "" }

It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Sertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years. It is not known if sertraline hydrochloride tablets are is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions. Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment.

{ "type": "p", "children": [], "text": "It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.\n \n\nSertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years.\n \n\nIt is not known if sertraline hydrochloride tablets are is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.\n \n\nTalk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment.\n " }

Who should not take sertraline hydrochloride tablets?

{ "type": "p", "children": [], "text": "\nWho should not take sertraline hydrochloride tablets?\n" }

Do not take sertraline hydrochloride tablets if you:

{ "type": "p", "children": [], "text": "\nDo not take sertraline hydrochloride tablets if you:\n" }

{ "type": "ul", "children": [ "take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.", "have taken an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your healthcare provider.", "have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.", "take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).", "take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.", "are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets.", "take Antabuse® (disulfiram) (if you are taking the liquid form of sertraline hydrochloride tablets) due to the alcohol content." ], "text": "" }

People who take sertraline hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

{ "type": "p", "children": [], "text": "\nPeople who take sertraline hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:\n" }

{ "type": "ul", "children": [ "high fever", "rapid changes in heart rate or blood pressure", "uncontrolled muscle spasms", "confusion", "stiff muscles", "loss of consciousness (pass out) " ], "text": "" }

What should I tell my healthcare provider before taking sertraline hydrochloride tablets?

{ "type": "p", "children": [], "text": "\nWhat should I tell my healthcare provider before taking sertraline hydrochloride tablets?\n" }

Before starting sertraline hydrochloride tablets, tell your healthcare provider:

{ "type": "p", "children": [], "text": "\nBefore starting sertraline hydrochloride tablets, tell your healthcare provider:\n" }

{ "type": "ul", "children": [ "\nif you have:\n", "liver problems", "heart problems", "bipolar disorder or mania", "kidney problems", "or have had seizures or convulsions", "low sodium levels in your blood", "a history of a stroke", "high blood pressure", "or have had bleeding problems ", "\nare pregnant or plan to become pregnant.Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride tablets during pregnancy.\n\t\n \nThere is a pregnancy registry for females who are exposed to sertraline hydrochloride tablets during pregnancy. The purpose of the registry is to collect information about the health of females exposed to sertraline hydrochloride tablets and their baby. If you or your child become pregnant during treatment with sertraline hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.\n\n", "\nare breastfeeding or plan to breastfeed. A small amount of sertraline hydrochloride tablets may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.\n " ], "text": "" }

Tell your healthcare provider about all the medicines that you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child take:

{ "type": "p", "children": [], "text": "\nTell your healthcare provider about all the medicines that you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.\n \n\nEspecially tell your healthcare provider if you or your child take: \n\n" }

{ "type": "ul", "children": [ "medicines used to treat migraine headaches called triptans", "tricyclic antidepressants", "lithium", "tramadol, fentanyl, meperidine, methadone, or other opioids", "tryptophan", "buspirone", "amphetamines", "phenytoin", "St. John’s Wort", "medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs", "(NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants", "diuretics", "medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)" ], "text": "" }

Sertraline hydrochloride tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects. Your healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride tablets with your other medicines. Do notstart or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.\n \n\nYour healthcare provider or pharmacist can tell you if it is safe to take sertraline hydrochloride tablets with your other medicines. \n Do notstart or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.\n " }

How should I take sertraline hydrochloride tablets?

{ "type": "p", "children": [], "text": "\nHow should I take sertraline hydrochloride tablets?\n" }

{ "type": "ul", "children": [ "Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.", "Sertraline hydrochloride tablets may be taken with or without food.", "If you miss a dose of sertraline hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. \n Do nottake two doses of sertraline hydrochloride tablets at the same time. \n " ], "text": "" }

If you take too much sertraline hydrochloride, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.

{ "type": "p", "children": [], "text": "\nIf you take too much sertraline hydrochloride, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.\n" }

What should I avoid while taking sertraline hydrochloride tablets?

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

Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. Do notdrink alcohol while you take sertraline hydrochloride tablets.

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline hydrochloride tablets affect you. \n Do notdrink alcohol while you take sertraline hydrochloride tablets.\n " }

What are the possible side effects of sertraline hydrochloride tablets?

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

Sertraline hydrochloride tablets may cause serious side effects, including:

{ "type": "p", "children": [], "text": "Sertraline hydrochloride tablets may cause serious side effects, including:" }

{ "type": "ul", "children": [ "\nSee “What is the most important information I should know about sertraline hydrochloride tablets?”\n" ], "text": "" }

The most common side effects in adults who take sertraline hydrochloride tablets include:

{ "type": "p", "children": [], "text": "\nThe most common side effects in adults who take sertraline hydrochloride tablets include:\n" }

{ "type": "ul", "children": [ "nausea, loss of appetite, diarrhea, or indigestion", "increased sweating", "tremor or shaking", "agitation", "change in sleep habits including increased sleepiness or insomnia", "sexual problems including decreased libido and ejaculation failure", "feeling tired or fatigued", "anxiety " ], "text": "" }

The most common side effects in children and adolescents who take includeabnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride tablets. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. How should I store sertraline hydrochloride tablets?

{ "type": "p", "children": [], "text": "\nThe most common side effects in children and adolescents who take includeabnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride tablets.\n \n\nTell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline hydrochloride tablets. For more information, ask your healthcare provider or pharmacist.\n \n\nCall your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.\n \n\nHow should I store sertraline hydrochloride tablets? \n" }

{ "type": "ul", "children": [ "Store sertraline hydrochloride tablets at room temperature, 20° to 25°C (68° to 77°F).", "Keep sertraline hydrochloride tablets bottle closed tightly." ], "text": "" }

Keep sertraline hydrochloride tablets and all medicines out of the reach of children. General information about the safe and effective use of sertraline hydrochloride tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which it was not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals. For more information about sertraline hydrochloride tablets call Aurobindo Pharma USA, Inc. at 1-866-850-2876. What are the ingredients in sertraline hydrochloride tablets? Active ingredient:sertraline hydrochloride Inactive ingredients: Tablets:microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. This Medication Guide has been approved by the U.S. Food and Drug Administration. All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

{ "type": "p", "children": [], "text": "\nKeep sertraline hydrochloride tablets and all medicines out of the reach of children.\n \n\nGeneral information about the safe and effective use of sertraline hydrochloride tablets \n \n\n\nMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline hydrochloride tablets for a condition for which it was not prescribed. Do not give sertraline hydrochloride tablets to other people, even if they have the same condition. It may harm them.\n \n\nThis Medication Guide summarizes the most important information about sertraline hydrochloride tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline hydrochloride tablets that is written for healthcare professionals.\n \n\nFor more information about sertraline hydrochloride tablets call Aurobindo Pharma USA, Inc. at 1-866-850-2876.\n \n\nWhat are the ingredients in sertraline hydrochloride tablets? \n\n\nActive ingredient:sertraline hydrochloride\n \n\nInactive ingredients: \n\n\nTablets:microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow.\n \n\nThis Medication Guide has been approved by the U.S. Food and Drug Administration.\n \n\nAll brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.\n \n" }

Repackaged By / Distributed By: RemedyRepack Inc.

{ "type": "p", "children": [], "text": "Repackaged By / Distributed By: RemedyRepack Inc." }

625 Kolter Drive, Indiana, PA 15701

{ "type": "p", "children": [], "text": "625 Kolter Drive, Indiana, PA 15701" }

(724) 465-8762

{ "type": "p", "children": [], "text": "(724) 465-8762" }

DRUG: Sertraline Hydrochloride

{ "type": "p", "children": [], "text": "DRUG: Sertraline Hydrochloride" }

GENERIC: Sertraline Hydrochloride

{ "type": "p", "children": [], "text": "GENERIC: Sertraline Hydrochloride" }

DOSAGE: TABLET, FILM COATED

{ "type": "p", "children": [], "text": "DOSAGE: TABLET, FILM COATED" }

ADMINSTRATION: ORAL

{ "type": "p", "children": [], "text": "ADMINSTRATION: ORAL" }

NDC: 70518-2448-0

{ "type": "p", "children": [], "text": "NDC: 70518-2448-0" }

NDC: 70518-2448-1

{ "type": "p", "children": [], "text": "NDC: 70518-2448-1" }

NDC: 70518-2448-2

{ "type": "p", "children": [], "text": "NDC: 70518-2448-2" }

NDC: 70518-2448-3

{ "type": "p", "children": [], "text": "NDC: 70518-2448-3" }

NDC: 70518-2448-4

{ "type": "p", "children": [], "text": "NDC: 70518-2448-4" }

NDC: 70518-2448-5

{ "type": "p", "children": [], "text": "NDC: 70518-2448-5" }

NDC: 70518-2448-6

{ "type": "p", "children": [], "text": "NDC: 70518-2448-6" }

NDC: 70518-2448-7

{ "type": "p", "children": [], "text": "NDC: 70518-2448-7" }

COLOR: yellow

{ "type": "p", "children": [], "text": "COLOR: yellow" }

SHAPE: CAPSULE

{ "type": "p", "children": [], "text": "SHAPE: CAPSULE" }

SCORE: Two even pieces

{ "type": "p", "children": [], "text": "SCORE: Two even pieces" }

SIZE: 13 mm

{ "type": "p", "children": [], "text": "SIZE: 13 mm" }

IMPRINT: A;1;8

{ "type": "p", "children": [], "text": "IMPRINT: A;1;8" }

PACKAGING: 30 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BLISTER PACK" }

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 in 1 BOTTLE PLASTIC" }

PACKAGING: 28 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 28 in 1 BLISTER PACK" }

PACKAGING: 90 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 90 in 1 BOTTLE PLASTIC" }

PACKAGING: 60 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 60 in 1 BOTTLE PLASTIC" }

PACKAGING: 30 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BLISTER PACK" }

PACKAGING: 30 in 1 BLISTER PACK

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BLISTER PACK" }

PACKAGING: 30 in 1 BOTTLE PLASTIC

{ "type": "p", "children": [], "text": "PACKAGING: 30 in 1 BOTTLE PLASTIC " }

ACTIVE INGREDIENT(S):

{ "type": "p", "children": [], "text": "ACTIVE INGREDIENT(S):" }

{ "type": "ul", "children": [ "SERTRALINE HYDROCHLORIDE 100mg in 1" ], "text": "" }

INACTIVE INGREDIENT(S):

{ "type": "p", "children": [], "text": "INACTIVE INGREDIENT(S):" }

{ "type": "ul", "children": [ "MICROCRYSTALLINE CELLULOSE", "SODIUM STARCH GLYCOLATE TYPE A POTATO", "HYDROXYPROPYL CELLULOSE (1600000 WAMW)", "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "MAGNESIUM STEARATE", "HYPROMELLOSE 2910 (6 MPA.S)", "TITANIUM DIOXIDE", "POLYETHYLENE GLYCOL 400", "POLYSORBATE 80", "FERRIC OXIDE YELLOW" ], "text": "" }