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ZOLOFT®Highlights (sertraline HCl)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZOLOFT safely and effectively. See full prescribing information for ZOLOFT.

ZOLOFT (sertraline hydrochloride) tablets, for oral use
ZOLOFT (sertraline hydrochloride) oral solution
Initial U.S. Approval: 1991

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1)
  • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)

RECENT MAJOR CHANGES

Warnings and Precautions, Sexual Dysfunction (5.11)7/2021

INDICATIONS AND USAGE

ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):

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

DOSAGE AND ADMINISTRATION

IndicationStarting DosageMaximum Dosage
MDD (2.1)50 mg per day200 mg per day
OCD (2.1)25 mg per day (ages 6–12)
50 mg per day (ages 13)
200 mg per day
PD, PTSD, SAD (2.1)25 mg per day200 mg per day
PMDD (2.2) continuous dosing50 mg per day150 mg per day
PMDD (2.2) intermittent dosing50 mg per day during luteal phase only100 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 (2.1)
  • See Full Prescribing Information for titration in PMDD (2.2)
  • Hepatic impairment:
    • Mild: Recommended starting and maximum dosage is half recommended dosage (2.4)
    • Moderate or severe: Not recommended (2.4)
  • When discontinuing ZOLOFT, reduce dose gradually (2.6, 5.4)
  • Oral solution: Must be diluted before administration (2.7)

DOSAGE FORMS AND STRENGTHS

  • Tablets: 25 mg, 50 mg and 100 mg (3)
  • Oral solution: 20 mg/mL (3)

CONTRAINDICATIONS

  • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4, 7.1)
  • Concomitant use of pimozide (4, 7.1)
  • Known hypersensitivity to sertraline or excipients (4, 5.4)
  • ZOLOFT oral solution only: Concomitant use of disulfiram (4)

WARNINGS AND PRECAUTIONS

  • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue ZOLOFT and initiate supportive treatment. (5.2)
  • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. (5.3)
  • Activation of Mania/Hypomania: Screen patients for bipolar disorder. (5.4)
  • Seizures: Use with caution in patients with seizure disorders. (5.6)
  • Angle Closure Glaucoma: Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles. (5.7)
  • QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation. (5.10)
  • Sexual Dysfunction: ZOLOFT may cause symptoms of sexual dysfunction. (5.11)

ADVERSE REACTIONS

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 (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Protein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. (7.1, 12.3)
  • CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1, 12.3)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate (8.1)
  • Pediatric use: Safety and effectiveness of ZOLOFT in pediatric patients other than those with OCD have not been established (8.4)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2021

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