Sertraline

Zoloft

Approved uses

• Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:

Forms and strengths

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

How it is taken

• 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: 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 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.

Must 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

Interactions

• 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. Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with ZOLOFT. Table 5. Clinically-Significant Drug Interactions with ZOLOFT Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome.

Warnings 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. Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric...

Common 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.

Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

How it acts

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

Label holder:

Viatris Specialty LLC

Label version:

8 August 2023

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.