LEXAPRO (escitalopram oxalate)

The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day. With once-daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of escitalopram in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose.

AbsorptionThe absolute bioavailability of citalopram is about 80% relative to an intravenous d...

14.1 Major Depressive Disorder Adults The efficacy of Lexapro as a treatment for major depressive disorder was established in three, 8-week, placebo-controlled studies conducted in outpatients between 18 and 65 years of age who met DSM-IV criteria for major depressive disorder. The primary outcome in all three studies was change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS). A fixed-dose study compared 10 mg daily Lexapro and 20 mg daily Lexapro to placebo and 40 mg daily citalopram. The 10 mg daily and 20 mg daily Lexapro treatment groups showed statistica...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )] Serotonin syndrome [see Warnings and Precautions ( 5.2 )] Discontinuation syndrome [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] Hyponatremia [see Warnings and Precautions ( 5.6 )] Incr...

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 [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.2 )] . Starting Lexapro in a patient wh...

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 ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing Lexapro, 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 diso...

7 DRUG INTERACTIONS 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 linezol...