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Mesalamine Controlled-Release Capsules
  • Professionals
  • FDA PI

Mesalamine Controlled-Release Capsules

Dosage form: capsule, extended release
Drug class:5-aminosalicylates

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

Mesalamine Controlled-Release Capsules Description

Mesalamine extended-release capsules, USP for oral administration are extended-release formulation of mesalamine, USP, an aminosalicylate anti-inflammatory agent for gastrointestinal use.

Chemically, mesalamine, USP is benzoic acid, 5-amino-2-hydroxy. It has a molecular weight of 153.14.

The structural formula is:

Each 500 mg mesalamine extended-release capsule contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, colloidal silicon dioxide, diacetylated monoglyceride, ethylcellulose, hypromellose, stearic acid, sugar spheres (corn starch and sucrose), talc, and white wax. The capsule shell contains FD&C Blue 1, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains ferrosoferric oxide, potassium hydroxide, and shellac.

FDA approved dissolution test specifications differ from USP.

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