phentermine and topiramate

FDA Drug Profile — phentermine and topiramate, Qsymia

Drug Details

Generic Name
phentermine and topiramate
Brand Names
phentermine and topiramate, Qsymia
Application Number
NDA022580
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
12
Dosage Forms
CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
PHENTERMINE HYDROCHLORIDE, TOPIRAMATE

Indications and Usage

1 INDICATIONS AND USAGE Phentermine and topiramate extended-release capsules are 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 and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Phentermine and topiramate extended-release capsules are a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, 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 and pediatric patients aged 12 years and older with obesity ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition ( 1 ) Limitations of Use: The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established ( 1 ). The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established ( 1 ).