Sertraline

Zoloft

01Approved uses

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Posttraumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

02Forms and strengths

• Tablets: 25 mg, 50 mg and 100 mg
• Oral solution: 20 mg/mL

03How it is taken

• 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: Mild: Recommended starting and maximum dosage is half recommended dosage; Moderate or severe: Not recommended
• When discontinuing ZOLOFT, reduce dose gradually
• Oral solution: Must be diluted before administration

04Must not be used when

• Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs
• Concomitant use of pimozide
• Known hypersensitivity to sertraline or excipients
• ZOLOFT oral solution only: Concomitant use of disulfiram

05Interactions

• 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.

06Warnings and precautions

• 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.
• Angle Closure Glaucoma: Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles.
• 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.

07Common side effects

• Most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all ZOLOFT-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3).
• Most common adverse reactions in trials of ZOLOFT (≥5% and twice placebo) by indication that were not mentioned previously.
• Most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction.

08Pregnancy

Based 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. 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.

09How it acts

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

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.