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Drug Information for SERTRALINE HCl (Caremark L.L.C.): INDICATIONS AND USAGE
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Major Depressive Disorder
Sertraline Hydrochloride Tablets are indicated for the treatment of major depressive disorder in adults.
The efficacy of Sertraline Hydrochloride Tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The antidepressant action of Sertraline Hydrochloride Tablets in hospitalized depressed patients has not been adequately studied.
The efficacy of Sertraline Hydrochloride Tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tables for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
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