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Medications and Drugs

GENERIC NAME: balsalazide disodium

BRAND NAME: Colazal

DRUG CLASS AND MECHANISM: Balsalazide disodium is an oral anti-inflammatory drug that is used for the treatment of ulcerative colitis. It is a form of mesalamine (5-aminosalicyclic acid) that is activated when it reaches the colon by the colonic bacteria. Other mesalamine-containing drugs include Pentasa, Rowasa, and Asacol. Balsalazide disodium was approved by the FDA in July of 2000.

PRESCRIPTION: yes

GENERIC AVAILABLE: no

PREPARATIONS: Capsule: 750 mg

STORAGE: Balsalazide disodium should be stored between 15 and 30°C (59 to 86°F)

PRESCRIBED FOR: Balsalazide is used to treat the signs and symptoms of mild to moderately active ulcerative colitis.

DOSING: The usual dose is 2250 mg (three 750mg capsules) taken three times daily for 8 to 12 weeks.

DRUG INTERACTIONS: There are no known drug interactions with balsalazide disodium.

PREGNANCY: Animal studies have not demonstrated any adverse effects on the fetus, however, there have been no studies in pregnant women. The physician, therefore, may prescribe balsalazide to pregnant women if he/she feels the potential benefit outweighs the theoretical risks.

NURSING MOTHERS: It is not known if balsalazide disodium is secreted into breast milk. Since many drugs are secreted, balsalazide disodium should not be taken by nursing women.

SIDE EFFECTS: The most commonly occurring side effects are headache (1 in 12 patients), abdominal pain (1 in 17 patients), nausea (1 in 20 patients), and diarrhea (1 in 20 patients).

Pharmacy Author: Emmanuel Saltiel, Pharm. D.
Medical Editor: Jay M. Marks, M.D.

Reference: FDA Prescribing Information


Last Editorial Review: 11/4/2001 7:53:00 PM




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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  • mesalamine, Pentasa, Rowasa, Asacol, Lialda, Canasa - Information about mesalamine - 5-aminosalicylic acid (Pentasa, Rowasa, Asacol, Lialda, Canasa), a drug used for the treatment of mild to moderately severe ulcerative colitis.

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