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June 29, 2022June 27, 2022 – The U.S. FDA has approved Qsymia® (phentermine/topiramate extended-release capsules – Vivus) to provide chronic weight management in pediatric patients who are at least 12 years old and have a body mass index (BMI) in the 95th percentile or greater (as standardized for age and sex).
- FDA approved since 2012, Qsymia should be used as an adjunct to a reduced-calorie diet and increased physical activity. It is also indicated to provide chronic weight management in adults who have an initial BMI) of:
- 30kg/m 2 of body surface area or greater, or
- 27kg/m 2 or greater, plus at least one weight-related comorbidity (such as hypertension, type 2 diabetes mellitus, or dyslipidemia).
- The recommended starting dose is 3.75mg/23mg (phentermine/topiramate) taken by mouth daily for 14 days. This is then increased to 7.5mg/46mg daily. Qsymia should be taken in the morning to prevent insomnia.
- After 12 weeks, the dosage may be increased in patients who have not had sufficient weight loss or BMI reduction to is 11.25mg/69mg once daily for 14 days followed by an increase to 15mg/92mg daily.
- Qsymia treatment should be gradually discontinued after an additional 12 weeks if the patient has not had sufficient weight loss or BMI reduction.