Jane S. Ricciuti, RPh, MS


September 20, 2002

In This Article

Antidepressant Agents

(Escitalopram oxalate) Tablets

Manufacturer: Forest Pharmaceuticals, Inc

Drug Approval Classification: Original New Drug Application (Approval Date: 8/14/02; 8/30/02)

Indication: Lexapro (escitalopram) is indicated for the treatment of major depressive disorder.

A major depressive episode (as defined in the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM-IV]) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms:

Depressed mood

  • Loss of interest in usual activities

  • Significant change in weight and/or appetite

  • Insomnia or hypersomnia

  • Psychomotor agitation or retardation

  • Increased fatigue

  • Feelings of guilt or worthlessness

  • Slowed thinking or impaired concentration

  • A suicide attempt or suicidal ideation

  • The efficacy of Lexapro in maintaining a response in patients with major depressive disorder who had responded to Lexapro during an 8-week acute treatment phase and were then observed for relapse during a period of up to 36 weeks was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

    Dosing: The recommended dosage of Lexapro is 10 mg once daily.

    A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg.

    Lexapro should be administered once daily, in the morning or evening, with or without food.

    Clinical Summary: Escitalopram is the S-enantiomer of racemic citalopram, and is presumed to be linked to the potentiation of serotonergic activity in the central nervous system (CNS) as a result of its inhibition of CNS neuronal reuptake of serotonin (5-HT). In an 8-week fixed-dose study, Lexapro 10 mg/day showed significantly greater mean improvement compared with placebo on the Montgomery-Asberg Depression Rating Scale (MADRS).

    Adverse Effects: Lexapro use is associated with insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating, increased fatigue, and somnolence.

    Pharmacokinetics: Escitalopram steady-state plasma concentrations are achieved within approximately 1 week. Food does not affect absorption. Escitalopram is 56% protein bound to plasma proteins.

    The recommended dose in hepatically impaired patients is 10 mg; in reduced hepatic function, oral clearance was reduced by 37% and the half-life was doubled.

    Drug-Drug Interactions: Lexapro labeling includes a Black Box warning for the potential for interaction with monoamine oxidase inhibitors (MAOIs). Serotonin reuptake inhibitor drugs coadministered with MAOIs have been associated with serious reactions, including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.

    Ketoconazole 200 mg administered with racemic citalopram 40 mg has shown a decrease in Cmax and AUC of ketoconazole by 21% and 10%, respectively.

    Lexapro (escitalopram oxalate) Labeling

    8/30/02 Approval Letter for expanded Lexapro indication


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