Escitalopram

Indications

Escitalopram is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s Lexapro (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 treatment of generalized anxiety disorder (GAD) in adults

Dosage and administration (summary)

Indication and Population Recommended Dosage MDD in Adults Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults 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 Administer once daily, morning or evening, with or without food Elderly patients: recommended dosage is 10 mg once daily Hepatic impairment: recommended dosage is 10 mg once daily ( 2.4 , 8.6 ) When discontinuing escitalopram, reduce dose gradually whenever possible Major Depressive…

Contraindications

Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration and Warnings and Precautions ].

Warnings and precautions

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue escitalopram and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms Seizures: Use with caution in patients with a history of seizure Activation of Mania/Hypomania: Screen patients for bipolar disorder Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion…

Storage and supply

How Supplied Escitalopram Oral Solution, USP, 5 mg/5 mL, a clear, colorless liquid with peppermint flavor 240 mL bottle (8 fluid oz) NDC# 62135-729-37 Unit Dose Cup of 10 mL NDC # 62135-729-10 20 Unit Dose Cups of 10 mL NDC # 62135-729-24 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Source: Escitalopram Oral (Escitalopram Oral Solution) — US FDA prescribing information, 2025-03-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.