phentermine and topiramate
phentermine and topiramate is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including Qsymia, phentermine and topiramate. Available dosage form: capsule, extended release.
Drug Details
- Generic Name
- phentermine and topiramate
- Brand Names
- Qsymia, phentermine and topiramate
- Application Number
- NDA022580
- Sponsor
- Catalent Pharma Solutions, LLC
- NDC Codes
- 16
- 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: Adult patients 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: Adult patients with obesity ( 1 ) 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 ( 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 ).