DOSAGE AND ADMINISTRATION
MAJOR DEPRESSIVE DISORDER
INITIAL TREATMENT
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 Efficacy Trials under CLINICAL PHARMACOLOGY). If the dose is increased to 20 mg, this should occur after a minimum of one week.
LEXAPRO should be administered once daily, in the morning or evening, with or without food.
SPECIAL POPULATIONS
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.
TREATMENT OF PREGNANT WOMEN DURING THE THIRD TRIMESTER
Neonates exposed to LEXAPRO and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with LEXAPRO during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering LEXAPRO in the third trimester.
MAINTENANCE TREATMENT
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 for periods of up to 36 weeks in 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 Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
GENERALIZED ANXIETY DISORDER
INITIAL TREATMENT
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.
LEXAPRO should be administered once daily, in the morning or evening, with or without food.
MAINTENANCE TREATMENT
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.
DISCONTINUATION OF TREATMENT WITH LEXAPRO
Symptoms associated with discontinuation of LEXAPRO and other SSRIs and SNRIs have been reported (see 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 PATIENTS TO OR FROM A MONOAMINE OXIDASE INHIBITOR
At least 14 days should elapse between discontinuation of an MAOI and initiation of LEXAPRO therapy. Similarly, at least 14 days should be allowed after stopping LEXAPRO before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
|
