Sertraline Hydrochloride Sertraline 100 MG Oral Tablet
INDICATIONS AND USAGE 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 tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY ).
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HOW SUPPLIED Sertraline hydrochloride tablets, contains sertraline hydrochloride equivalent to 100 mg of sertraline. Sertraline hydrochloride tablets are supplied as: 100 mg Tablets: yellow colored, biconvex, capsule shaped film coated tablets debossed with â€˜Aâ€™ on one side and with a score line in between â€˜1â€™ and â€˜8â€™ on the other side. NDC 63739-490-41 Bottles of 30 Store at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted to 15Â° to 30Â°C (59Â° to 86Â°F) [see USP Controlled Room Temperature]. Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ), Mahaboob Nagar (Dt) AP-509302, INDIA Distributed by: McKesson Packaging Services, A business unit of McKesson Corporation, 7101 Weddington Rd, Concord, NC 28027. M.L.No.: 22/MN/AP/2009/F/G McKesson Assigned No.: IS-490-M67-01-B Issued: 09/2010
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