Complete SPL Sections#
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES SECTION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
BOXED WARNING SECTION
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 )].
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14 )] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
100 mg Tablets Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Taking pimozide [See Drug Interactions ( 7.1 )]. With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions ( 6.1 , 6.2 )] .
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications ( 4 )] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications ( 4 ) , Clinical Pharmacology ( 12.2 )] ] Suicidal thoughts and behaviors [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 of mania/hypomania [See Warnings and Precautions ( 5.4) ] Discontinuation syndrome [See Warnings and Precautions ( 5.5 )] Seizures [See Warnings and Precautions ( 5.6 )] Angle-closure glaucoma [See Warnings and Precautions ( 5.7 )] Hyponatremia [See Warnings and Precautions ( 5.8 )] Sexual Dysfunction [See Warnings and Precautions ( 5.11 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
The following have been reported with sertraline tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
11 DESCRIPTION
DESCRIPTION SECTION
Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17 H 17 NCl 2 •HCl is represented by the following structural formula: Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
Efficacy of sertraline hydrochloride was established in the following trials: MDD: two short-term trials and one maintenance trials in adults [See Clinical Studies ( 14.1 )]. OCD: three short-term trials in adults and one short-term trial in pediatric patients [See Clinical Studies ( 14.2 )]. PD: three short-term trials and one maintenance trial in adults [See Clinical Studies ( 14.3 )]. PTSD: two short-term trials and one maintenance trial in adults [See Clinical Studies ( 14.4 )] . SAD: two short-term trials and one maintenance trial in adults [See Clinical Studies ( 14.5 )]. PMDD: two short-term trials in adult female patients [See Clinical Studies ( 14.6 )].
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Sertraline Hydrochloride Tablets USP, 100 mg Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. NDC: 70518-4590-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Preserve in tight containers. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
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 hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, lithium, tryptophan, buspirone, amphetamines, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )]. Increased Risk of Bleeding Inform patients about the concomitant use of sertraline hydrochloride tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions ( 5.3 )]. Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome Advise patients not to abruptly discontinue sertraline hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when sertraline hydrochloride tablets are discontinued [See Warnings and Precautions ( 5.5 )]. Sexual Dysfunction Advise patients that use of sertraline hydrochloride tablets may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.11 )]. Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions ( 6.2 )]. Pregnancy Inform pregnant women that sertraline hydrochloride tablets may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations ( 8.1 )]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride tablets during pregnancy LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
Medication Guide Sertraline Hydrochloride (ser' tra leen hye'' droe klor' ide) Tablets What is the most important information I should know about sertraline hydrochloride tablets? Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency. 1. Suicidal thoughts or actions: Sertraline hydrochloride tablets 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. 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. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive or violent new or worse depression feeling agitated, restless, angry or irritable an increase in activity or talking more than what is normal for you acting on dangerous impulses thoughts about suicide or dying new or worse anxiety or panic attacks trouble sleeping other unusual changes in behavior or mood 2. Serotonin Syndrome . This condition can be life-threatening and symptoms may include: agitation, hallucinations, coma, or other changes in mental status racing heartbeat, high or low blood pressure coordination problems or muscle twitching (overactive reflexes) nausea, vomiting, or diarrhea sweating or fever muscle rigidity 3. Increased chance of bleeding : Sertraline hydrochloride tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 4. Manic episodes . Symptoms may include: greatly increased energy racing thoughts unusually grand ideas severe trouble sleeping reckless behavior excessive happiness or irritability talking more or faster than usual 5. Seizures or convulsions. 6. Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline hydrochloride tablets may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 7. Changes in appetite or weight . Children and adolescents should have height and weight monitored during treatment. 8. Low salt (sodium) levels in the blood . Elderly people may be at greater risk for this. Symptoms may include: Headache weakness or feeling unsteady confusion, problems concentrating or thinking, memory problems 9. Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SSRIs), including sertraline hydrochloride tablets, 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 hydrochloride tablets. There may be treatments your healthcare provider can suggest. Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider . Stopping sertraline hydrochloride tablets too quickly may cause serious symptoms including: 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? Sertraline hydrochloride tablet is a prescription medicine used to treat: Major Depressive Disorder (MDD) Panic Disorder Social Anxiety Disorder Obsessive Compulsive Disorder (OCD) Posttraumatic Stress Disorder (PTSD) Premenstrual Dysphoric Disorder (PMDD) It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Sertraline hydrochloride tablets are safe and effective in treating children with OCD age 6 to 17 years. It is not known if sertraline hydrochloride tablets are safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions. Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride tablets treatment. Who should not take sertraline hydrochloride tablets? Do not take sertraline hydrochloride tablets if you: take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. have taken an MAOI within 2 weeks of stopping sertraline hydrochloride tablets unless directed to do so by your healthcare provider. have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride). take the antipsychotic medicine pimozide (Orap ® ) because this can cause serious heart problems. are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets. take Antabuse ® (disulfiram) (if you are taking the liquid form of sertraline hydrochloride tablets) due to the alcohol content. 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 rapid changes in heart rate or blood pressure uncontrolled muscle spasms confusion stiff muscles loss of consciousness (pass out) What should I tell my healthcare provider before taking sertraline hydrochloride tablets? Before starting sertraline hydrochloride tablets, tell your healthcare provider: if you have: liver problems heart problems bipolar disorder or mania kidney problems. or have had seizures or convulsions low sodium levels in your blood a history of a stroke high blood pressure or have had bleeding problems are pregnant or plan to become pregnant . Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline hydrochloride tablets during pregnancy. There is a pregnancy registry for females who are exposed to sertraline hydrochloride tablets during pregnancy. The purpose of the registry is to collect information about the health of females exposed to sertraline hydrochloride tablets and their baby. If you or your child become pregnant during treatment with sertraline hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/ant...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Sertraline Hydrochloride GENERIC: Sertraline Hydrochloride DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-4590-0 COLOR: yellow SHAPE: CAPSULE SCORE: Two even pieces SIZE: 13 mm IMPRINT: L;U;D03 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): SERTRALINE HYDROCHLORIDE 100mg in 1 INACTIVE INGREDIENT(S): ANHYDROUS DIBASIC CALCIUM PHOSPHATE ASCORBIC ACID CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE VANILLIN
