Escitalopram 5 mg Tablets — Generic For Lexapro — Torrent

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

ESCITALOPRAM tablets, for oral use

Initial U.S. Approval: 2002

Warning: Suicidal Thoughts And Behaviors

See full prescribing information for complete boxed warning.

Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). Escitalopram tablets are not approved for use in pediatric patients less than 7 years of age (8.4).

Recent Major Changes

Indications (1) 5/2023

Dosage and Administration (2.2, 2.3, 2.5) 5/2023

Dosage and Administration, Use of Escitalopram

with Other MAOIs such as Linezolid or

Methylene Blue (2.7) - Removed 5/2023

Warnings and Precautions (5.2, 5.7) 8/2023

Indications And Usage

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the:

Dosage And Administration

Indication and PopulationRecommended Dosage

MDD in Adults (2.1)Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

MDD in Pediatric Patients 12 years and older (2.1)Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

GAD in Adults (2.2)Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

Dosage Forms And Strengths

Tablets: 5 mg, 10 mg (scored), and 20 mg (scored)

Contraindications

Do not use MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of stopping treatment with escitalopram. Do not use escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue (4)

Concomitant use of pimozide (4)

Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4)

Warnings And Precautions

• (5.2, 5.7) 8/2023 INDICATIONS AND USAGE Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the:
• treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1)
• treatment of generalized anxiety disorder (GAD) in adults (1) DOSAGE AND ADMINISTRATION Indication and Population Recommended Dosage MDD in Adults (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults (2.2) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily
• No additional benefits were seen at 20 mg once daily (2.1)
• Administer once daily, morning or evening, with or without food (2.3)
• Elderly patients: recommended dosage is 10 mg once daily (2.4)
• Hepatic impairment: recommended dosage is 10 mg once daily (2.4, 8.6)
• When discontinuing Escitalopram tablets, reduce dose gradually whenever possible (2.5) DOSAGE FORMS AND STRENGTHS

• (5.2, 5.7) 8/2023 INDICATIONS AND USAGE Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the:
• treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1)
• treatment of generalized anxiety disorder (GAD) in adults (1) DOSAGE AND ADMINISTRATION Indication and Population Recommended Dosage MDD in Adults (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults (2.2) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily
• No additional benefits were seen at 20 mg once daily (2.1)
• Administer once daily, morning or evening, with or without food (2.3)
• Elderly patients: recommended dosage is 10 mg once daily (2.4)
• Hepatic impairment: recommended dosage is 10 mg once daily (2.4, 8.6)
• When discontinuing Escitalopram tablets, reduce dose gradually whenever possible (2.5) DOSAGE FORMS AND STRENGTHS

Adverse Reactions

Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Use In Specific Populations

Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate (8.1)

Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO® (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2025