Escitalopram 5 mg Tablets — Generic For Lexapro — SOLCO

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).

Indications And Usage

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

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

GAD in Pediatric Patients 7 years and older (2.2)

Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

Dosage Forms And Strengths

Contraindications

Warnings And Precautions

• Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram tablets and serotonergic agents and initiate supportive treatment (4, 5.2)
• Discontinuation syndrome: When discontinuing escitalopram tablets, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms (5.3)
• Seizures: Use with caution in patients with a history of seizure (5.4)
• Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.5)
• Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion (5.6)
• Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk (5.7)
• Interference with Cognitive and Motor Performance: Use caution when operating machinery (5.8)
• Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.9)

• Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram tablets and serotonergic agents and initiate supportive treatment (4, 5.2)
• Discontinuation syndrome: When discontinuing escitalopram tablets, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms (5.3)
• Seizures: Use with caution in patients with a history of seizure (5.4)
• Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.5)
• Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion (5.6)
• Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk (5.7)
• Interference with Cognitive and Motor Performance: Use caution when operating machinery (5.8)
• Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.9)

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 Solco Healthcare LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Use In Specific Populations

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2026