COLAZAL SUMMARY
COLAZAL ® (balsalazide disodium) Capsules
(kôl a zal)
Each COLAZAL® capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid), an anti inflammatory drug. Each daily dose of COLAZAL® (6.75 grams) is equivalent to 2.4 grams of mesalamine.
COLAZAL® is indicated for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL® beyond 12 weeks has not been established.
Two double-masked, clinical studies (N=259) have shown COLAZAL® to be effective in the treatment of the signs and symptoms of active ulcerative colitis. In one study, the indicated dose of COLAZAL® showed superior effectiveness to a lower dose of COLAZAL®. The percentage of patients improved in measures of stool blood, stool frequency and sigmoidoscopic score after eight weeks of treatment. A second study, conducted in Europe, confirmed these findings of symptomatic improvement.
The most frequently reported adverse events in clinical trials (N=259) included headache (8%), abdominal pain (6%) and nausea (5%). The overall reporting of adverse events was similar to those reported by patients receiving placebo.
COLAZAL® is contraindicated in patients with hypersensitivity to salicylates or to any components of the
COLAZAL® capsules or balsalazide metabolites. COLAZAL® capsules are sulfa-free and do not contain lactose.
COLAZAL® capsules are available as 750mg gelatin capsules, 280 capsules per bottle. The usual course of therapy is eight to twelve weeks.
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