"March 14, 2012 -- The FDA approved the first generic version of the popular antidepressant Lexapro (escitalopram) today. Like the brand-name drug, the generic is approved for the treatment of both adult depression and generalized anxiety disorder"...
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Major Depressive Disorder
Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies].
A major depressive episode (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 five of the following nine 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.
Generalized Anxiety Disorder
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
DOSAGE AND ADMINISTRATION
Lexapro should be administered once daily, in the morning or evening, with or without food.
Major Depressive Disorder
The recommended dose of Lexapro is 10 mg once daily. A flexible-dose trial of Lexapro (10 to 20 mg/day) demonstrated the effectiveness of Lexapro [see Clinical Studies]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
The recommended dose 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 [see Clinical Studies]. If the dose is increased to 20 mg, this should occur after a minimum of one week.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing Lexapro 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking Lexapro during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies]. 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. Patients should be periodically reassessed to determine the need for maintenance treatment.
Generalized Anxiety Disorder
The recommended starting dose of Lexapro is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of Lexapro in the treatment of GAD beyond 8 weeks has not been systematically studied. 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.
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Lexapro should be used with caution in patients with severe renal impairment.
Discontinuation of Treatment with Lexapro
Symptoms associated with discontinuation of Lexapro and other SSRIs and SNRIs have been reported [see WARNINGS AND PRECAUTIONS]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Lexapro. Conversely, at least 14 days should be allowed after stopping Lexapro before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].
Use of Lexapro with Other MAOIs such as Linezolid or Methylene Blue
Do not start Lexapro in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].
In some cases, a patient already receiving Lexapro therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Lexapro should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Lexapro may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Lexapro is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with “FL” on one side and either “5”, “10”, or “20” on the other side according to their respective strengths.
Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base.
5 mg Tablets:
Bottle of 100 NDC # 0456-2005-01
White to off-white, round, non-scored, film-coated. Imprint “FL” on one side of the tablet and “5” on the other side.
10 mg Tablets:
Bottle of 100 NDC # 0456-2010-01
10 x 10 Unit Dose NDC # 0456-2010-63
White to off-white, round, scored, film-coated. Imprint on scored side with “F” on the left side and “L” on the right side. Imprint on the non-scored side with “10”.
20 mg Tablets:
Bottle of 100 NDC # 0456-2020-01
10 x 10 Unit Dose NDC # 0456-2020-63
White to off-white, round, scored, film-coated. Imprint on scored side with “F” on the left side and “L” on the right side. Imprint on the non-scored side with “20”.
5 mg/5 mL, peppermint flavor (240 mL) NDC # 0456-2101-08
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).
Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO 63045 USA. Licensed from H. Lundbeck A/S. Revised: December 2012
Last reviewed on RxList: 12/18/2012
This monograph has been modified to include the generic and brand name in many instances.
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