SERTRALINE HYDROCHLORIDE- sertraline hydrochloride_tablet, film coated

CLINICAL PHARMACOLOGY
The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro In vitro 1 2 1A 1B 2 Systemic Bioavailability max max max max max max max in vitro in vivo max min In vitro 3 PRECAUTIONS Pediatric Pharmacokinetics max max max max DOSAGE AND ADMINISTRATION PRECAUTIONS DOSAGE AND ADMINISTRATION PRECAUTIONS Major Depressive Disorder Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.
Pharmacodynamics
The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro In vitro 1 2 1A 1B 2
Pharmacokinetics
Systemic Bioavailability max max max max max max max in vitro in vivo max min In vitro 3 PRECAUTIONS Pediatric Pharmacokinetics max max max max DOSAGE AND ADMINISTRATION PRECAUTIONS DOSAGE AND ADMINISTRATION PRECAUTIONS
Drugs Metabolized by P450 2D6
Many drugs effective in the treatment of major depressive disorder, e.g., the SSRIs, including sertraline, and most tricyclic antidepressant drugs effective in the treatment of major depressive disorder inhibit the biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by P450 2D6. The drugs for which this potential interaction is of greatest concern are those metabolized primarily by 2D6 and which have a narrow therapeutic index, e.g., the tricyclic antidepressant drugs effective in the treatment of major depressive disorder 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 P450 2D6 by the antidepressant and the therapeutic index of the co-administered drug. There is variability among the drugs effective in the treatment of major depressive disorder 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. Consequently, concomitant use of a drug metabolized by P450 2D6 with sertraline hydrochloride may require lower doses than usually prescribed for the other drug. Furthermore, whenever sertraline hydrochloride is withdrawn from co-therapy, an increased dose of the co-administered drug may be required (see Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs) PRECAUTIONS CONTRAINDICATIONS WARNINGS DOSAGE AND ADMINISTRATION Triptans WARNINGS - Serotonin Syndrome

Major Depressive Disorder Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY Obsessive-Compulsive Disorder Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION Panic Disorder Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION Posttraumatic Stress Disorder (PTSD) Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION Premenstrual Dysphoric Disorder (PMDD) Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION Social Anxiety Disorder Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY

Initial Treatment Dosage for Adults Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY Clinical Trials CLINICAL PHARMACOLOGY CONTRAINDICATIONS CONTRAINDICATIONS WARNINGS WARNINGS Special Populations CLINICAL PHARMACOLOGY PRECAUTIONS PRECAUTIONS Symptoms associated with discontinuation of sertraline hydrochloride tablets and other SSRIs and SNRIs, have been reported (see PRECAUTIONS.

Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including sertraline hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and 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 and intravenous methylene blue). CONTRAINDICATIONS DOSAGE AND ADMINISTRATION
Hyponatremia
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including sertraline hydrochloride. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk (see Geriatric Use
ADVERSE REACTIONS
During its premarketing assessment, multiple doses of sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder. TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive OCD Panic Disorder PTSD Body System/Adverse Sertraline Placebo Sertraline Placebo Sertraline Placebo Sertraline Placebo (1) (2) Autonomic Nervous System Disorders Ejaculation Failure (1) 7 <1 17 2 19 1 11 1 Mouth Dry 16 9 14 9 15 10 11 6 Sweating Increased 8 3 6 1 5 1 4 2 Center. & Periph. Nerv. System Disorders Somnolence 13 6 15 8 15 9 13 9 Tremor 11 3 8 1 5 1 5 1 Dizziness 12 7 17 9 10 10 8 5 General Fatigue 11 8 14 10 11 6 10 5 Pain 1 2 3 1 3 3 4 6 Malaise <1 1 1 1 7 14 10 10 Gastrointestinal Disorders Abdominal Pain 2 2 5 5 6 7 6 5 Anorexia 3 2 11 2 7 2 8 2 Constipation 8 6 6 4 7 3 3 3 Diarrhea/Loose Stools 18 9 24 10 20 9 24 15 Dyspepsia 6 3 10 4 10 8 6 6 Nausea 26 12 30 11 29 18 21 11 Psychiatric Disorders Agitation 6 4 6 3 6 2 5 5 Insomnia 16 9 28 12 25 18 20 11 Libido Decreased 1 <1 11 2 7 1 7 2 PMDD Daily Dosing PMDD Luteal Phase Dosing (2) Social Anxiety Disorder Body System/Adverse Event Sertraline Hydrochloride (N=121) Placebo (N=122) Sertraline Hydrochloride (N=136) Placebo (N=127) Sertraline Hydrochloride (N=344) Placebo (N=268) Autonomic Nervous System Disorders Ejaculation Failure (1) N/A N/A N/A N/A 14 - Mouth Dry 6 3 10 3 12 4 Sweating Increased 6 <1 3 0 11 2 Center. & Periph. Nerv. System Disorders Somnolence 7 <1 2 0 9 6 Tremor 2 0 <1 <1 9 3 Dizziness 6 3 7 5 14 6 General Fatigue 16 7 10 <1 12 6 Pain 6 <1 3 2 1 3 Malaise 9 5 7 5 8 3 Gastrointestinal Disorders Abdominal Pain 7 <1 3 3 5 5 Anorexia 3 2 5 0 6 3 Constipation 2 3 1 2 5 3 Diarrhea/Loose Stools 13 3 13 7 21 8 Dyspepsia 7 2 7 3 13 5 Nausea 23 9 13 3 22 8 Psychiatric Disorders Agitation 2 <1 1 0 4 2 Insomnia 17 11 12 10 25 10 Libido Decreased 11 2 4 2 9 3 TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined Body System/Adverse Event** Sertraline Placebo (1) Autonomic Nervous System Disorders Ejaculation Failure (1) 14 1 Mouth Dry 14 8 Sweating Increased 7 2 Center. & Periph. Nerv. System Disorders Somnolence 13 7 Dizziness 12 7 Headache 25 23 Paresthesia 2 1 Tremor 8 2 Disorders of Skin and Appendages Rash 3 2 Gastrointestinal Disorders Anorexia 6 2 Constipation 6 4 Diarrhea/Loose Stools 20 10 Dyspepsia 8 4 Nausea 25 11 Vomiting 4 2 General Fatigue 12 7 Psychiatric Disorders Agitation 5 3 Anxiety 4 3 Insomnia 21 11 Libido Decreased 6 2 Nervousness 5 4 Special Senses Vision Abnormal 3 2 Associated with Discontinuation in Placebo-Controlled Clinical Trials TABLE 4 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS Adverse Event Major Depressive Major OCD Panic PTSD PMDD PMDD Social (1) Abdominal Pain en dash en dash en dash en dash en dash en dash en dash 1% Agitation en dash 1% en dash 2% en dash en dash en dash en dash Anxiety en dash en dash en dash en dash en dash en dash en dash 2% Diarrhea/ Loose Stools 2% 2% 2% 1% en dash 2% en dash en dash Dizziness en dash en dash 1% en dash en dash en dash en dash en dash Dry Mouth en dash 1% en dash en dash en dash en dash en dash en dash Dyspepsia en dash en dash en dash 1% en dash en dash en dash en dash Ejaculation Failure (1) 1% 1% 1% 2% en dash N/A N/A 2% Fatigue en dash en dash en dash en dash en dash en dash en dash 2% Headache 1% 2% en dash en dash 1% en dash en dash 2% Hot Flushes en dash en dash en dash en dash en dash en dash 1% en dash Insomnia 2% 1% 3% 2% en dash en dash 1% 3% Nausea 3% 4% 3% 3% 2% 2% 1% 2% Nervousness en dash en dash en dash en dash en dash 2% en dash en dash Palpitation en dash en dash en dash en dash en dash en dash 1% en dash Somnolence 1% 1% 2% 2% en dash en dash en dash en dash Tremor en dash 2% en dash en dash en dash en dash en dash en dash Male and Female Sexual Dysfunction with SSRIs TABLE 5 Adverse Event Sertraline Placebo * ** Ejaculation failure * 14% 1% Decreased libido ** 6% 1% There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment. PRECAUTIONS Autonomic Nervous System Disorders en dash Frequent: Infrequent: Rare: Body as a Whole en dash General Disorders en dash Rare: Cardiovascular en dash Frequent: Infrequent Rare: Central and Peripheral Nervous System Disorders en dash Frequent: Infrequent: Rare: Disorders of Skin and Appendages en dash lnfrequent: Rare: Endocrine Disorders en dash Rare: Gastrointestinal Disorders en dash Frequent: Infrequent: Rare: General en dash Frequent: Infrequent: Rare: Hearing and Vestibular Disorders en dash Rare: Hematopoietic and Lymphatic en dash Rare: Liver and Biliary System Disorders en dash Rare: Metabolic and Nutritional Disorders en dash Infrequent: Rare: Musculoskeletal System Disorders en dash Frequent: Infrequent: Psychiatric Disorders en dash Frequent: Infrequent: Rare: Reproductive en dash Infrequent: Rare: Respiratory System Disorders en dash Frequent: Infrequent: Rare: Special Senses en dash Frequent: Infrequent: Rare: Urinary System Disorders en dash Infrequent: Rare:

The use of MAOIs intended to treat psychiatric disorders with sertraline hydrochloride tablets or within 14 days of stopping treatment with sertraline hydrochloride tablets is contraindicated because of an increased risk of serotonin syndrome. The use of sertraline hydrochloride tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS DOSAGE AND ADMINISTRATION WARNINGS DOSAGE AND ADMINISTRATION PRECAUTIONS

Pregnancy
Teratogenic Effects Pregnancy Category C 2 2 2 2 2 in utero Neonates exposed to sertraline hydrochloride and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. 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. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS DOSAGE AND ADMINISTRATION.
Nursing Mothers
It is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sertraline hydrochloride is administered to a nursing woman.
Pediatric Use
The efficacy of sertraline hydrochloride for the treatment of obsessive-compulsive disorder was demonstrated in a 12-week, multicenter, placebo-controlled study with 187 outpatients ages 6 to 17 (see Clinical Trials CLINICAL PHARMACOLOGY BOX WARNING WARNINGS-Clinical Worsening and Suicide Risk Pharmacokinetics CLINICAL PHARMACOLOGY ADVERSE REACTIONS WARNINGS en dash Clinical Worsening and Suicide Risk
Geriatric Use
U.S. geriatric clinical studies of sertraline hydrochloride in major depressive disorder included 663 sertraline hydrochloride-treated subjects >= 65 years of age, of those, 180 were >= 75 years of age. No overall differences in the pattern of adverse reactions were observed in the geriatric clinical trial subjects relative to those reported in younger subjects (see ADVERSE REACTIONS PRECAUTIONS, Hyponatremia

Drug Interactions
Potential Effects of Coadministration of Drugs Highly Bound to Plasma Proteins max max max CONTRAINDICATIONS CONTRAINDICATIONS WARNINGS DOSAGE AND ADMINISTRATION in vivo max Many drugs effective in the treatment of major depressive disorder, e. , the SSRIs, including sertraline, and most tricyclic antidepressant drugs effective in the treatment of major depressive disorder inhibit the biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by P450 2D6. The drugs for which this potential interaction is of greatest concern are those metabolized primarily by 2D6 and which have a narrow therapeutic index, e. , the tricyclic antidepressant drugs effective in the treatment of major depressive disorder 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 P450 2D6 by the antidepressant and the therapeutic index of the co-administered drug. There is variability among the drugs effective in the treatment of major depressive disorder 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. Consequently, concomitant use of a drug metabolized by P450 2D6 with sertraline hydrochloride may require lower doses than usually prescribed for the other drug. Furthermore, whenever sertraline hydrochloride is withdrawn from co-therapy, an increased dose of the co-administered drug may be required (see Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs) PRECAUTIONS CONTRAINDICATIONS WARNINGS DOSAGE AND ADMINISTRATION Triptans WARNINGS - Serotonin Syndrome The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with sertraline hydrochloride, because sertraline may inhibit TCA metabolism. Plasma TCA concentrations may need to be monitored, and the dose of TCA may need to be reduced, if a TCA is co-administered with sertraline hydrochloride (see Drugs Metabolized by P450 2D6 PRECAUTIONS 2 2 2 2 in vivo in vitro 2.
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)
The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with sertraline hydrochloride, because sertraline may inhibit TCA metabolism. Plasma TCA concentrations may need to be monitored, and the dose of TCA may need to be reduced, if a TCA is co-administered with sertraline hydrochloride (see Drugs Metabolized by P450 2D6 PRECAUTIONS 2 2 2 2 in vivo in vitro 2

Clinical Trials
Major Depressive Disorder Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.
WARNINGS
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Increases Compared to Placebo <18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case > 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. PRECAUTIONS DOSAGE AND ADMINISTRATIONem dashDiscontinuation of Treatment with Sertraline Hydrochloride Tablets Such monitoring should include daily observation by families and caregivers. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that sertraline hydrochloride is not approved for use in treating bipolar depression. The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including sertraline hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and 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 and intravenous methylene blue). CONTRAINDICATIONS DOSAGE AND ADMINISTRATION.
Labor and Delivery
The effect of sertraline hydrochloride on labor and delivery in humans is unknown.
OVERDOSAGE
Human Experience Physicians’ Desk Reference registered registered
Medication Guide
Sertraline Hydrochloride Tablets USP (ser'' tra leen hye'''' droe klor'' ide) 1. Suicidal thoughts or actions: Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions first few months of treatment or when the dose is changed. 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. Pay particular attention to such changes when sertraline hydrochloride tablets are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Sertraline hydrochloride tablets may be associated with these serious side effects: 2. Serotonin Syndrome agitation, hallucinations, coma or other changes in mental status coordination problems or muscle twitching (overactive reflexes) racing heartbeat, high or low blood pressure sweating or fever nausea, vomiting, or diarrhea muscle rigidity 3. Severe allergic reactions: trouble breathing swelling of the face, tongue, eyes or mouth rash, itchy welts (hives) or blisters, alone or with fever or joint pain 4. Abnormal bleeding: registered registered 5. Seizures or convulsions 6. Manic episodes: greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual 7. Changes in appetite or weight. Low salt (sodium) levels in the blood. headache weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems 9. Visual problems eye pain changes in vision 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. anxiety, irritability, high or low mood, feeling restless or changes in sleep habits headache, sweating, nausea, dizziness electric shock-like sensations, shaking, confusion What are sertraline hydrochloride tablets? also Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder Posttraumatic Stress Disorder (PTSD) Social Anxiety Disorder Premenstrual Dysphoric Disorder (PMDD) Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment. Who should not take sertraline hydrochloride tablets? 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 the antipsychotic medicine pimozide (Orap registered 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. Do not take an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your physician. Do not start sertraline hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. 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: high fever uncontrolled muscle spasms stiff muscles rapid changes in heart rate or blood pressure confusion loss of consciousness (pass out) What should I tell my healthcare provider before taking sertraline hydrochloride tablets? Are taking certain drugs such as: Medicines used to treat migraine headaches such as: triptans Medicines used to treat mood, anxiety, psychotic or thought disorders, such as: tricyclic antidepressants lithium diazepam SSRIs SNRIs antipsychotic drugs valproate Medicines used to treat seizures such as: phenytoin Medicines used to treat pain such as: tramadol Medicines used to thin your blood such as: warfarin Medicines used to control your heartbeat such as : propafenone flecainide digitoxin Medicines used to treat type II diabetes such as: tolbutamide Cimetidine used to treat heartburn Over-the-counter medicines or supplements such as: Aspirin or other NSAIDs tryptophan St. John’s Wort have liver problems have kidney problems have heart problems have or had seizures or convulsions have bipolar disorder or mania have low sodium levels in your blood have a history of a stroke have high blood pressure have or had bleeding problems are pregnant or plan to become pregnant. It is not known if sertraline hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy. are breast-feeding or plan to breast-feed. Some 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 tablets. Tell your healthcare provider about all the medicines that you take, If you take sertraline hydrochloride tablets, you should not take any other medicines that contain sertraline (sertraline hydrochloride etc.). How should I take sertraline hydrochloride tablets? 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. Do not take two doses of sertraline hydrochloride tablets at the same time. If you take too much sertraline hydrochloride, call your healthcare provider or poison control center right away, or get emergency treatment. What should I avoid while taking sertraline hydrochloride tablets? See “What is the most important information I should know about sertraline hydrochloride tablets?” Feeling anxious or trouble sleeping Common possible side effects in people who take sertraline hydrochloride tablets include: nausea, loss of appetite, diarrhea or indigestion change in sleep habits including increased sleepiness or insomnia increased sweating sexual problems including decreased libido and ejaculation failure tremor or shaking feeling tired or fatigued agitation Other side effects in children and adolescents include: abnormal increase in muscle movement or agitation nose bleed urinating more often urinary incontinence aggressive reaction heavy menstrual periods 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. How should I store sertraline hydrochloride tablets? Store sertraline hydrochloride tablets at room temperature 20° to 25°C (68° to 77°F). Keep sertraline hydrochloride tablets bottle closed tightly. Keep sertraline hydrochloride tablets and all medicines out of the reach of children. General information about sertraline hydrochloride tablets What are the ingredients in sertraline hydrochloride tablets ? Active ingredient: Inactive ingredients: registered registered registered Aurobindo Pharma USA, Inc. Aurobindo Pharma Limited

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SERTRALINE HYDROCHLORIDE- sertraline hydrochloride_tablet, film coated Product manual source documgent