Sertraline 25 mg Tablets — Generic For Zoloft — Aurobindo

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

SERTRALINE HYDROCHLORIDE tablets, for oral use

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 (5.2, 5.3) 8/2023

Indications And Usage

Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):

Major depressive disorder (MDD)

Obsessive-compulsive disorder (OCD)

Panic disorder (PD)

Posttraumatic stress disorder (PTSD)

Social anxiety disorder (SAD)

Premenstrual dysphoric disorder (PMDD)

Dosage And Administration

­Indication

Starting Dosage

Maximum Dosage

Mdd (2.1)

50 mg per day

200 mg per day

Ocd (2.1)

25 mg per day (ages 6 to 12)

50 mg per day (ages ≥ 13)

200 mg per day

Pd, Ptsd, Sad (2.1)

25 mg per day

200 mg per day

PMDD (2.2) continuous dosing

50 mg per day

150 mg per day

PMDD (2.2) 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 to 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 sertraline hydrochloride tablets, reduce dose gradually (2.6, 5.4)

Dosage Forms And Strengths

Tablets: 25 mg, 50 mg and 100 mg (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)

Warnings And Precautions

• (5.2, 5.3) 8/2023 INDICATIONS AND USAGE Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Posttraumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD) DOSAGE AND ADMINISTRATION ­Indication Starting Dosage Maximum Dosage MDD (2.1) 50 mg per day 200 mg per day OCD (2.1) 25 mg per day (ages 6 to 12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD (2.1) 25 mg per day 200 mg per day PMDD (2.2) continuous dosing 50 mg per day 150 mg per day PMDD (2.2) 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 to 50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)

• (5.2, 5.3) 8/2023 INDICATIONS AND USAGE Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Posttraumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD) DOSAGE AND ADMINISTRATION ­Indication Starting Dosage Maximum Dosage MDD (2.1) 50 mg per day 200 mg per day OCD (2.1) 25 mg per day (ages 6 to 12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD (2.1) 25 mg per day 200 mg per day PMDD (2.2) continuous dosing 50 mg per day 150 mg per day PMDD (2.2) 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 to 50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline hydrochloride and serotonergic agents 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 sertraline hydrochloride, in patients with untreated anatomically narrow angles. (5.7)

QTc Prolongation: Sertraline hydrochloride should be used with caution in patients with risk factors for QTc prolongation. (5.10)

Sexual Dysfunction: sertraline hydrochloride 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 sertraline hydrochloride 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 sertraline hydrochloride in pediatric patients other than those with OCD have not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2023