WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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.

Contraindications

ZOLOFT is 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
• Taking pimozide
• With known hypersensitivity to sertraline (eg, anaphylaxis, angioedema) or excipients
• ZOLOFT oral solution is contraindicated in patients taking disulfiram. ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction.

Warnings and Precautions

Serotonin Syndrome: ZOLOFT can precipitate serotonin syndrome, a potentially life-threatening condition. There is an increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue ZOLOFT and serotonergic agents and initiate supportive treatment.

Increased Risk of Bleeding: ZOLOFT may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. 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. Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents or anticoagulants.

Activation of Mania or Hypomania: Prior to initiating treatment with ZOLOFT, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. It should be noted that ZOLOFT is not approved for use in treating bipolar disorder.

Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances, 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.

Seizures: ZOLOFT should be prescribed with caution in patients with a seizure disorder.

Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles, treated with antidepressants.

Hyponatremia: Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including ZOLOFT. Discontinuation of ZOLOFT should be considered in patients with symptomatic hyponatremia, and appropriate medical intervention should be instituted.

QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation.

Sexual Dysfunction: ZOLOFT may cause symptoms of sexual dysfunction.

Patients should be told that until they learn how they respond to ZOLOFT, they should be careful doing activities during which they need to be alert, such as driving a car or operating machinery.

Adverse Reactions

• The most commonly observed adverse reactions in patients treated with ZOLOFT (incidence of 5% or greater and at least twice the incidence in placebo patients) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido.
• In pediatric patients treated with ZOLOFT, the overall profile of adverse events was generally similar to that seen in adult studies. The following additional adverse events were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate: fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety. Safety and effectiveness of ZOLOFT in pediatric patients other than those with OCD have not been established.

Drug Interactions

• Protein-bound drugs: Monitor for drug reactions and reduce dosage of ZOLOFT or other protein-bound drugs (eg, warfarin) as warranted.
• CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6.

Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate.

Hepatic Impairment: The recommended dosage in patients with mild hepatic impairment is half the recommended dosage. The use of ZOLOFT in patients with moderate or severe hepatic impairment is not recommended.

Pediatric Use: Safety and efficacy of ZOLOFT have been established in the treatment of OCD in pediatric patients aged 6 to 17. 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.

Indications

ZOLOFT is approved by the FDA to treat, in adults, major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD). It is also approved to treat obsessive compulsive disorder (OCD) in children and adolescents aged 6-17 years.

Please see Full Prescribing Information, including BOXED WARNING and Medication Guide.