What is the generic name?

NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE

What is the Trade Name for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE?

Contrave Extended-Release

What are the Indications for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese) or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese) or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). ( 1 ) Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. ( 1 ) The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established. ( 1 )

References: https://open.fda.gov/