naltrexone hydrochloride and bupropion hydrochloride

FDA Drug Profile — Contrave Extended-Release

Drug Details

Generic Name
naltrexone hydrochloride and bupropion hydrochloride
Brand Names
Contrave Extended-Release
Application Number
NDA200063
Sponsor
Nalpropion Pharmaceuticals LLC
NDC Codes
1
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE CONTRAVE is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. ( 1 ) Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated. ( 1 , 4 ) Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. CONTRAVE contains naltrexone and bupropion. Coadministration with other naltrexone-containing products is not recommended. Coadministration with other bupropion-containing products is contraindicated.