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Colazal (Balsalazide Disodium) - Summary

 


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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.
See all Colazal indications & dosage >>

COLAZAL NEWS HIGHLIGHTS

Media Articles Related to Colazal (Balsalazide)

Once Daily Salofalk Granules Now Available In 1.5G Sachet For Ulcerative Colitis
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2008.11.14]

APRISO(TM) Granted FDA Marketing Approval For Maintenance Of Remission Of Ulcerative Colitis
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.11.04]

APRISO™ Granted FDA Marketing Approval For Maintenance Of Remission Of Ulcerative Colitis
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.11.03]

88.7% Of Ulcerative Colitis Patients In Remission Remained Relapse-Free At 12 Months With Once Daily Mezavant(R) XL (MMX Mesalazine)
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.10.10]

Mesalamine Granules Maintain Remission In Ulcerative Colitis Patients Who Switch From Another 5-ASA
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.10.08]

more >>

Published Studies Related to Colazal (Balsalazide)

Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. [2005.12.01]

Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. [2004.11]

Comparative pharmacokinetics of equimolar doses of 5-aminosalicylate administered as oral mesalamine (Asacol) and balsalazide: a randomized, single-dose, crossover study in healthy volunteers. [2004.05.15]

Patient-led variable dosing with balsalazide as long-term therapy for maintenance in ulcerative colitis: a 3-year prospective observational study. [2004.02.15]

Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to-moderate ulcerative colitis. [2002.12]

more >>

Clinical Trials Related to Colazal (Balsalazide)

Fed Study of Balsalazide Disodium Capsules 750 mg and ColazalŪ Capsules 750 mg [Completed]

Fasting Study of Balsalazide Disodium Capsules 750 mg and ColazalŪ Capsules 750 mg [Completed]

Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions [Completed]

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions [Completed]

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis [Completed]

more >>

Page last updated: 2008-11-14

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