bupropion hydrochloride tablet film coated extended release
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
ROUND WHITE WPI 3385
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
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
More pills like ROUND WPI 3385