Amneal Pharmaceuticals NY LLC

Sertraline

Generic

Generic for Sertraline hcl

ID: 69238278901

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Capsule

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150 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosage in Patients with MDD and OCD 2.2 Administration Instructions

🩺What it's for

Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies (14)]: Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline Hydrochloride (HCl) Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1): Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and…

💊How to take it

Do not initiate treatment with Sertraline HCl Capsules. Use another sertraline HCl product for initial dosage, titration, and dosages below 150 mg once daily (2.1) Recommended dosage is 150 mg or 200 mg once daily (2.1) Maximum recommended dosage is 200 mg once daily (2.1) Swallow capsules whole. Do not open, crush, or chew (2.2) When discontinuing Sertraline HCl Capsules, reduce dose gradually whenever possible.

ℹ️Common side effects

The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline or excipients of Sertraline HCl Capsules [see Contraindications (4)] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Contraindications (4), Warnings and Precautions (5.2), Drug Interactions (7.1)] Increased Risk of Bleeding [see Warnings and Precautions (5.3)] Activation…

⚠️Serious risks

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

📋Interactions & cautions

Protein-bound drugs: Monitor for adverse reactions and reduce dosage of Sertraline HCl Capsules or other protein-bound drugs (e.g., warfarin) as warranted (7.1, 12.3) CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1, 12.3)

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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 4,500 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. 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 Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo < 18 years old 14 additional patients 18 years to 24 years old 5 additional patients Decreases Compared to Placebo 25 years to 64 years old 1 fewer patient 65 years old 6 fewer patients 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.

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 3,066 adults. These 3,066 patients exposed to sertraline for 8 weeks 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. MDD: somnolence OCD: insomnia, agitation 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* Sertraline Hydrochloride (N = 3,066) % Placebo (N = 2,293) % Cardiac disorders Palpitations 4 2 Eye disorders Visual impairment 4 2 Gastrointestinal Disorders Nausea 26 12 Diarrhea/Loose Stools 20 10 Dry mouth 14 9 Dyspepsia 8 4 Constipation 6 4 Vomiting 4 1 General disorders and administration site conditions Fatigue 12 8 Metabolism and nutrition disorders Decreased appetite 7 2 Nervous system disorders Dizziness 12 8 Somnolence 11 6 Tremor 9 2 Psychiatric Disorders Insomnia 20 13 Agitation 8 5 Libido Decreased 6 2 Reproductive system and breast disorders Ejaculation failure (1) 8 1 Erectile dysfunction (1) 4 1 Ejaculation disorder (1) 3 0 Male sexual dysfunction (1) 2 0 Skin and subcutaneous tissue disorders Hyperhidrosis 7 3 (1) Denominator used was for male patients only (n = 1,316 sertraline; n = 973 placebo). * 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. Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controlled studies, 368 (12%) of the 3,066 patients who received sertraline discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2,293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline-treated patients: All sertraline -treated patients (MDD, OCD, and Other Conditions): nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%). MDD (> 2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting. OCD: somnolence. 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. 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 Sertraline Hydrochloride % Placebo % Men only (N = 1,316) (N = 973) Ejaculation failure 8 1 Libido decreased 7 2 Erectile dysfunction 4 1 Ejaculation disorder 3 0 Male sexual dysfunction 2 0 Women only (N = 1,750) (N = 1,320) Libido decreased 4 2 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

Table 4 includes clinically significant drug interactions with Sertraline HCl Capsules [see Clinical Pharmacology (12.3)]. Table 4. Clinically-Significant Drug Interactions with Sertraline HCl Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs, including Sertraline HCl Capsules, and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline HCl Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.2)]. Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and Sertraline HCl Capsules is contraindicated [see Contraindications (4)]. Other Serotonergic Drugs Clinical Impact: 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. Intervention: 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 [see Warnings and Precautions (5.2)]. Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with Sertraline HCl Capsules may potentiate the risk of bleeding. Intervention: 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 [see Warnings and Precautions (5.3)]. Drugs Highly Bound to Plasma Protein Clinical Impact: 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 [see Clinical Pharmacology (12.3)]. Intervention: Monitor for adverse reactions and reduce dosage of Sertraline HCl Capsules or other protein-bound drugs as warranted. Drugs Metabolized by CYP2D6 Clinical Impact: Sertraline HCl Capsules are a CYP2D6 inhibitor [see Clinical Pharmacology (12.3)]. The concomitant use of Sertraline HCl capsules with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. Intervention: 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. Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug. Sertraline HCl Capsules may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating Sertraline HCl Capsules. Reduce phenytoin dosage if needed. Drugs that Prolong the QTc Interval Clinical Impact: 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 [see Warnings and Precautions (5.10), Clinical Pharmacology (12.2)]. Intervention: Pimozide is contraindicated for use with Sertraline HCl Capsules. Avoid the concomitant use of drugs known to prolong the QTc interval.

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.

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 mg 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 mg/kg/day, 10 mg/kg/day, 40 mg/kg/day 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 mg/kg/day 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 years to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

Absorption Following a single dose of Sertraline HCl Capsule at 150 mg, the mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5 hours 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 mg 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 ng/mL to 500 ng/mL. However, at up to 300 ng/mL 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 hours 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 hour to 24-hour), Cmax and Cmin, with about a 5-fold 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 years to 12 years, 32 aged 13 years to 17 years) including both males (N = 28) and females (N = 33). Relative to the adults, pediatric patients aged 6 years to 12 years and 13 years 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 years to 32 years old) individuals. Steady-state, therefore, was achieved after 2 weeks 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 to 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 mL/min to 60 mL/min), moderate to severe (CLcr = 10 mL/min 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 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 mg/day 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 1,000 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.

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). Study MDD-1 was an 8-week, 3-arm study with flexible dosing of sertraline, amitriptyline, and placebo. Adult patients received sertraline (N = 126, in a daily dose titrated weekly to 50 mg, 100 mg, or 200 mg), amitriptyline (N = 123, in a daily dose titrated weekly to 50 mg, 100 mg, or 150 mg), or placebo (N = 130). Study MDD-2 was a 6-week, multicenter parallel study of three fixed doses of sertraline administered once daily at 50 mg (N = 82), 100 mg (N = 75), and 200 mg (N = 56) doses and placebo (N = 76) in the treatment of adult outpatients with MDD. 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 mg/day to 200 mg/day. These patients (n = 295) were randomized to continuation on double-blind sertraline 50 mg/day 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 years 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. Study OCD-1 was an 8-week randomized, placebo-controlled study with flexible dosing of sertraline in a range of 50 mg/day to 200 mg/day, titrated in 50 mg increments every 4 days to a maximally tolerated dose; the mean dose for completers was 186 mg/day. Patients receiving sertraline (N = 43) experienced a mean reduction of approximately 4 points on the Y-BOCS total score which was statistically significantly greater than the mean reduction of 2 points in placebo-treated patients (N = 44). The mean change in Y -BOCS from baseline to last visit (the primary efficacy endpoint) was -3.79 (sertraline) and -1.48 (placebo). Study OCD-2 was a 12-week randomized, placebo-controlled fixed-dose study, including sertraline doses of 50 mg/day, 100 mg/day, and 200 mg/day. Sertraline (N = 240) was titrated to the assigned dose over two weeks in 50 mg increments every 4 days. Patients receiving sertraline doses of 50 mg/day and 200 mg/day experienced mean reductions of approximately 6 points on the Y-BOCS total score, which were statistically significantly greater than the approximately 3 point reduction in placebo-treated patients (N = 84). The mean change in Y-BOCS from baseline to last visit (the primary efficacy endpoint) was -5.7 (pooled results from sertraline 50 mg, 100 mg, and 150 mg) and -2.85 (placebo). Study OCD-3 was a 12-week randomized, placebo controlled study with flexible dosing of sertraline in a range of 50 mg/day to 200 mg/day; the mean dose for completers was 185 mg/day. Sertraline (N = 241) was titrated to the assigned dose over two weeks in 50 mg increments every 4 days. Patients receiving sertraline experienced a mean reduction of approximately 7 points on the Y-BOCS total score which was statistically significantly greater than the mean reduction of approximately 4 points in placebo-treated patients (N = 84). The mean change in Y-BOCS from baseline to last visit (the primary efficacy endpoint) was - 6.5 (sertraline) and -3.6 (placebo). 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 mg/day 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 condition 1 and condition 2, and condition 3 being met at visit 3): Condition 1: Y-BOCS score increased by 5 points, to a minimum of 20, relative to baseline; Condition 2: CGI-I increased by one point; and Condition 3: Worsening of the patient s condition in the investigator s judgment, to justify alternative treatment. 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 years 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 day 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.

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 Warning and Warnings and Precautions (5.1)]. Serotonin Syndrome 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 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 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 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 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) 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)]. Pregnancy Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with Sertraline HCl Capsules. 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)]. Manufactured by: Ritsa Pharma Private Limited Hyderabad, Telangana 500078, India (IND) Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2026-00

Sertraline (ser' tra leen) HCl Capsules What is the most important information I should know about Sertraline Hydrochloride (HCl) Capsules? Sertraline HCl Capsules may cause serious side effects, including: Increased risk of suicidal thoughts or actions. 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 first few months of treatment or when the dose is changed. How can I watch for and try to prevent suicidal thoughts and actions? Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. 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. 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. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. 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: attempts to commit suicide acting aggressive or violent new or worse depression feeling agitated, restless, angry, or irritable an increase in activity and 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 What are Sertraline HCl Capsules? Sertraline HCl Capsules are a prescription medicine used to treat: A certain type of depression called Major Depressive Disorder (MDD) in adults. Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older. 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. Do not take Sertraline HCl Capsules if you or your child: are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI). are being treated with the antibiotic linezolid or intravenous methylene blue. are taking the antipsychotic medicine pimozide because this can cause serious problems. 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. 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. Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Sertraline HCl Capsules. Before taking Sertraline HCl Capsules, tell your healthcare provider about all medical conditions, including if you or your child: have or have had bleeding problems have, or have a family history of, bipolar disorder, mania, or hypomania have or have had seizures or convulsions have high pressure in the eye (glaucoma) have low sodium levels in your blood have heart problems have kidney or liver problems have an allergy or sensitivity to FD&C Yellow No. 5 (Tartrazine) 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. Tell your healthcare provider right away if you or your child becomes pregnant during treatment with Sertraline HCl Capsules. 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. Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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 work. 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. Especially tell your healthcare provider if you or your child take: 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 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. 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, What are the possible side effects of Sertraline HCl Capsules? 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. How should I take Sertraline HCl Capsules? 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. Take Sertraline HCl Capsules with or without food. Swallow Sertraline HCl Capsules whole. Do not open, crush, or chew Sertraline HCl Capsules. 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. 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. What are the possible side effects of Sertraline HCl Capsules? Sertraline HCl Capsules may cause serious side effects, including: See, What is the most important information I should know about Sertraline HCl Capsules? Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when Sertraline HCl Capsules are taken with certain other medicines. See, Who should not take Sertraline HCl Capsules? Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome: agitation sweating seeing or hearing things that are not real (hallucinations) flushing confusion high body temperature (hyperthermia) coma shaking (tremors), stiff muscles, or muscle twitching fast heartbeat loss of coordination changes in blood pressure seizures dizziness nausea, vomiting, diarrhea Increased chance of bleeding. 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. Manic episodes. Manic episodes may happen in people with bipolar disorder who take Sertraline HCl Capsules. Symptoms may include: greatly increased energy unusually grand ideas reckless behavior talking more or faster than usual racing thoughts severe problems sleeping excessive happiness or irritability Discontinuation syndrome. 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: nausea sweating changes in mood irritability and agitation dizziness electric shock feeling (paresthesia) tremor anxiety confusion headache tiredness problems sleeping hypomania ringing in the ears (tinnitus) seizures Seizures or convulsions. Eye problems (angle-closure glaucoma). 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. Low sodium levels in your blood (hyponatremia). 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: headache difficulty concentrating memory changes confusion weakness and unsteadiness which can lead to falls In more severe or more sudden cases, signs and symptoms include: seeing or hearing things that are not real (hallucinations) fainting seizures coma stopping breathing (respiratory arrest) Changes in the electrical activity of the heart. 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. FD&C Yellow No. 5. Sertraline HCl Capsules contain FD&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. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including Sertraline HCl Capsules, may cause sexual problems. Symptoms in males may include: Delayed ejaculation or inability to have an ejaculation Decreased sex drive Problems getting or keeping an erection Symptoms in females may include: Decreased sex drive Delayed orgasm or inability to have an orgasm 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. The most common side effects of Sertraline HCl Capsules include: nausea, diarrhea, or loose stool tremor or shaking indigestion decreased appetite increased sweating sexual problems including decreased libido and ejaculation problems These are not all the possible side effects of Sertraline HCl Capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Sertraline HCl Capsules? Store Sertraline HCl Capsules at room temperature between 68 F to 77 F (20 C to 25 C). Keep Sertraline HCl Capsules bottle tightly closed. Keep Sertraline HCl Capsules and all medicines out of the reach of children. General information about the safe and effective use of Sertraline HCl Capsules . 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. What are the ingredients in Sertraline HCl Capsules ? Active ingredient: sertraline hydrochloride, USP Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, propyl gallate, 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. The capsules are printed with black ink composed of ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. Manufactured by: Ritsa Pharma Private Limited Hyderabad, Telangana 500078, India (IND) Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 For more information about Sertraline Hydrochloride Capsules, call Amneal Pharmaceuticals LLC at 1-877-835-5472. This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 01-2026-00