Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults.The efficacy of sertraline 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 in hospitalized depressed patients has not been adequately studied.The efficacy of sertraline 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 for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS).Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).Sertraline is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets.
Cases of serious sometimes fatal reactions have been reported in patients receiving sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI), in combination with a monoamine oxidase inhibitor (MAOI).
Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on an MAOI.
Some cases presented with features resembling neuroleptic malignant syndrome.
Therefore, sertraline should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI.Similarly, at least 14 days should be allowed after stopping sertraline before starting an MAOI.