Escitalopram

Lexapro 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 and pediatric patients 7 years of age and older. Lexapro 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 and pediatric patients 7 years and older

The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

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 GAD in Pediatric Patients 7 years and older. 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. When discontinuing Lexapro, reduce dose gradually whenever possible

Lexapro is contraindicated in patients: taking MAOIs with Lexapro or within 14 days of stopping treatment with Lexapro because of an increased risk of serotonin syndrome. The use of Lexapro within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting Lexapro in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. taking pimozide. with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro.

Boxed warning (suicidal thoughts and behaviors): Antidepressants increased the risk of suicidal thoughts and behavior s in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Lexapro is not approved for use in pediatric patients less than 7 years of age [ s ee Use in Specific Populations ]. Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue Lexapro and serotonergic agents and initiate supportive treatment. Discontinuation syndrome: When discontinuing Lexapro, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms. Seizures: Use with caution in patients with a history of seizure.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults Serotonin syndrome Discontinuation syndrome Seizures Activation of mania or hypomania Hyponatremia Increased Risk of Bleeding Interference with Cognitive and Motor Performance Angle-closure glaucoma Use in Patients with Concomitant Illness Sexual Dysfunction 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

Table 6 presents clinically important drug interactions with Lexapro. TABLE 6 Clinically Important Drug Interactions with Lexapro Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including Lexapro, and MAOIs increases the risk of serotonin syndrome. Intervention: Lexapro is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue. Pimozide Clinical Impact: Concomitant use of racemic citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of racemic citalopram alone. Intervention: Lexapro is contraindicated in patients taking pimozide.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15 to 30°C (59° to 86°F).