Drug Information for SERTRALINE HCl (Caremark L.L.C.): DOSAGE AND ADMINISTRATION

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  • Initial Treatment

    Dosage for Adults

    Major Depressive Disorder

    Sertraline treatment should be administered at a dose of 50 mg once daily.

    While a relationship between the dose and effect has not been established for major depressive disorder, patients were dosed in a range of 50 to 200 mg/day in the clinical trials demonstrating the effectiveness of sertraline for the treatment of this indication. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week.

    Sertraline should be administered once daily, either in the morning or evening.

    Maintenance/Continuation/Extended Treatment

    Major Depressive Disorder

    It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50 to 200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.

    Switching Patients to or from a Monoamine Oxidase Inhibitor

    At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with sertraline. In addition, at least 14 days should be allowed after stopping sertraline before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

    Special Populations

    Dosage for Hepatically Impaired Patients

    The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Treatment of Pregnant Women During the Third Trimester

    Neonates exposed to sertraline 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 sertraline during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering sertraline in the third trimester.

    Discontinuation of Treatment with Sertraline Hydrochloride Tablets

    Symptoms associated with discontinuation of sertraline 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.

  • Drug Information Provided by National Library of Medicine (NLM).
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