Sertraline Hcl Prescribing Information
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.
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 to 24 years old | 5 additional patients |
Decreases Compared to Placebo | |
| 25 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.
Warnings and Precautions (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 , Drug Interactions ] . 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 , Drug Interactions ] .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 ] . 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. | 8/2023 |
Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following
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 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.
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 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, 100, 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 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 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 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):
- 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.
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.
- Major depressive disorder (MDD) in adults
- Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
- 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 Dosage in Patients with MDD and OCDDo 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.
- Recommended dosage is 150 mg or 200 mg once daily ()
2.1 Dosage in Patients with MDD and OCDDo 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.
- Maximum recommended dosage is 200 mg once daily ()
2.1 Dosage in Patients with MDD and OCDDo 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.
- Swallow capsules whole. Do not open, crush, or chew ()
2.2 Administration InstructionsAdminister Sertraline HCl Capsules orally. Swallow capsules whole; do not open, crush, or chew.
- When discontinuing Sertraline HCl Capsules, reduce dose gradually whenever possible. Gradual dosage reduction will require use of another sertraline HCl product (,
2.5 Discontinuation of Treatment with Sertraline HCl CapsulesAdverse reactions may occur upon discontinuation of Sertraline HCl Capsules
[see Warnings and Precautions ]. 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.)5.5 Discontinuation SyndromeAdverse 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 ].
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.
- Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate ()
8.1 PregnancyPregnancy Exposure RegistryThere 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 SummaryBased 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 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/m2basis 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 ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskA 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 ReactionsUse of Sertraline HCl Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage
[see Warnings and Precautions ].Fetal/Neonatal Adverse ReactionsExposure 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).DataHuman DataThird 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 ].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 20thweek 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 DataReproduction 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/m2basis 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/m2basis) in rats and 40 mg/kg (3.9 times the MRHD on a mg/m2basis) 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/m2basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m2basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown.
- Pediatric use: Safety and effectiveness in pediatric patients other than those with OCD (6 to 17 years) have not been established ()
8.4 Pediatric UseThe 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 , Clinical Pharmacology , Clinical Studies ]. 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 CapsulesMonitor 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 ]. 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 MDDIn 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 DataA 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).
- Hepatic Impairment: Not recommended ()
8.6 Hepatic ImpairmentSertraline 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 ].Dosage adjustments are not possible with the available strengths of Sertraline HCl Capsules.