Sertraline

ZOLOFT is indicated for the treatment of the following: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

Indication Starting Dosage Maximum Dosage MDD 50 mg per day 200 mg per day OCD 25 mg per day (ages 6-12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD 25 mg per day 200 mg per day PMDD continuous dosing 50 mg per day 150 mg per day PMDD intermittent dosing 50 mg per day during luteal phase only 100 mg per day during luteal phase only • If inadequate response to starting dosage, titrate in 25-50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD. • See Full Prescribing Information for titration in PMDD. • Hepatic impairment: o Mild: Recommended starting and maximum dosage is half recommended dosage o Moderate or severe: Not recommended. • When discontinuing ZOLOFT, reduce dose gradually. • Oral solution: Must be diluted before administration

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 (e.g., anaphylaxis, angioedema). In addition to the contraindications for all ZOLOFT formulations listed above, 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. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs.

Boxed 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. • Serotonin Syndrome: 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: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. • Activation of Mania/Hypomania: Screen patients for bipolar disorder. • Seizures: Use with caution in patients with seizure disorders.

The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity reactions to sertraline • Disulfiram-alcohol reaction when ZOLOFT oral solution is taken with disulfiram • QTc prolongation and ventricular arrhythmias when taken with pimozide • Suicidal thoughts and behaviors • Serotonin syndrome • Increased risk of bleeding • Activation of mania/hypomania • Discontinuation syndrome • Seizures • Angle-closure glaucoma • Hyponatremia • Sexual Dysfunction Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido.

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

Store ZOLOFT at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).