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12 HR Bupropion Hydrochloride 100 MG Extended Release Oral Tablet

INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY ). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Aphena Pharma Solutions - Tennessee, LLC


5 years ago ROUND WHITE WPI 858 12 HR Bupropion Hydrochloride 100 MG Extended Release Oral Tablet

ROUND WHITE WPI 858

HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Bupropion hydrochloride extended-release tablets (SR), 100 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 858 in bottles of 60 tablets (NDC 0591-3540-60), 100 tablets (NDC 0591-3540-01) and 500 tablets (NDC 0591-3540-05). Bupropion hydrochloride extended-release tablets (SR), 150 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 839 in bottles of 60 tablets (NDC 0591-3541-60), 100 tablets (NDC 0591-3541-01), 250 tablets (NDC 0591-3541-25) and 500 tablets (NDC 0591-3541-05). Bupropion hydrochloride extended-release tablets (SR), 200 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets with WPI over 3385 in bottles of 60 tablets (NDC 0591-3542-60), 100 tablets (NDC 0591-3542-01) and 500 tablets (NDC 0591-3542-05). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Wellbutrin, Wellbutrin XL, and Zyban are registered trademarks of GlaxoSmithKline. Kaletra is a registered trademark of Abbott Laboratories. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2013 172395-5


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