Giazo
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.
Limitations of Use:
- Effectiveness of GIAZO in the treatment of female patients was not demonstrated in clinical trials (see Clinical Trials (14.1)].
- Safety and effectiveness of GIAZO therapybeyond 8 weeks have not been established.
History
There is currently no drug history available for this drug.
Other Information
Each GIAZOtablet contains 1.1 g of balsalazide disodium, an orally available prodrug that is enzymatically cleaved to produce mesalamine (5‑aminosalicylic acid, 5‑ASA), an anti-inflammatory drug. 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 insoluble in acid, but soluble at a pH of at least 4.5. 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 tablet contains hypromellose, magnesium stearate, and Opadry II Yellow. The sodium content of each tablet is approximately 126 mg.
Sources
Giazo Manufacturers
-
Salix Pharmaceuticals, Inc.
![Giazo (Balsalazide Disodium) Tablet, Film Coated [Salix Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Giazo | Salix Pharmaceuticals, Inc.
The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.
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