Balsalazide Disodium Recall
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Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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Balsalazide disodium capsules, USP are indicated for the treatment of mildly to moderately active ulcerative colitis in adults. Safety and effectiveness of balsalazide beyond 12 weeks in adults have not been established.
There is currently no drug history available for this drug.
Each balsalazide disodium capsule, USP contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of balsalazide (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2- carboxyethyl)amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:
Molecular Weight: 437.32
Molecular Formula: C17H13N3O6Na2•2H2O
Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder.It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.
Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide, magnesium stearate and titanium dioxide. The capsule imprinting ink contains propylene glycol, strong ammonia solution, shellac and red iron oxide. The sodium content of each capsule is approximately 86 mg.
Balsalazide Disodium Manufacturers
- Physicians Total Care, Inc.
- Roxane Laboratories, Inc
- Apotex Corp.
- Mylan Pharmaceuticals Inc.
- Clinical Solutions Wholesale
- American Health Packaging
- Par Pharmaceutical Companies, Inc.
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