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Dosage Forms And Strengths
Qsymia capsules are formulated in the following four strength combinations (phentermine mg/topiramate mg extended-release):
- 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
- 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
- 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
- 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]
Storage And Handling
Qsymia is available as phentermine hydrochloride (expressed as the weight of the free base)/topiramate extended-release gelatin capsules in the following strengths and colors:
- 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
- 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
- 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
- 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]
The capsules are supplied as follows:
| Strength | NDC Code | |
| Unit of Use Bottle (14 capsules) | 3.75 mg/23 mg capsules | 62541-201-14 |
| Pharmacy Bottle (30 capsules) | 3.75 mg/23 mg capsules | 62541-201-30 |
| Unit of Use Bottle (30 capsules) | 7.5 mg/46 mg capsules | 62541-202-30 |
| Unit of Use Bottle (30 capsules) | 15 mg/92 mg capsules | 62541-204-30 |
| Pharmacy Bottle (30 capsules) | 11.25 mg/69 mg capsules | 62541-203-30 |
| Starter Pack - Blister Configuration | 3.75 mg/23 mg and | 62541-210-28 |
| (28 Capsules) | 7.5 mg/46 mg capsules | |
| Dose Escalation Pack - Blister | 11.25 mg/69 mg and | 62541-220-28 |
| Configuration (28 Capsules) | 15 mg/92 mg capsules |
Store at controlled room temperature, 15°C to 25°C (59°F to 77°F). Keep container tightly closed and protect from moisture.
VIVUS, Inc 351 East Evelyn Avenue Mountain View, CA 94041 USA. Issued: 09/2014
Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of
- 30 kg/m² or greater (obese), or
- 27 kg/m² or greater (overweight) in the presence of at least one weight related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
Limitations of Use
The effect of Qsymia on cardiovascular morbidity and mortality has not been established.
The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations have not been established.
