Phenterminedrug info
24 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral Capsule
What it is used for
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 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 and over-the-counter drugs, and herbal preparations, have not been established.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 31, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C 10 H 16 ClN and its molecular weight is 185.69 g mol -1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is: Topiramate, USP Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C 12 H 21 NO 8 S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is: Phentermine and Topiramate Extended-Release Capsules Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:
3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP).
7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP).
11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP).
15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1..
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 31, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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