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COLAZAL – balsalazide disodium


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This information is intended for U.S. Healthcare Professionals only.

For additional information on COLAZAL® (balsalazide disodium) Capsules 750mg and its use in ulcerative colitis, please see the following list of references:

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Das KM, Eastwook MA, McManus JPH, Sircus W. Adverse reactions during salicylazosulphapyridine therapy and the relation with drug metabolism and acetylator phenotype. N Engl J Med. 1973;289:491-495.

Dew MJ, Hughes PJ, Lee MG, Evans BK, Rhodes J. An oral preparation to release drugs in the human colon. Br J Clin Pharmacol. 1982;14:405-408.

Giaffer MH, Holdsworth CD, Lennard-Jones JE, et al. Improved maintenance of remission in ulcerative colitis by balsalazide 4 g/day compared with 2 g/day. Aliment Pharmacol Ther. 1992;6(4):479-485.

Giaffer MH, O'Brien CJ, Holdsworth CD. Clinical tolerance to three 5-aminosalicylic acid releasing preparations in patients with inflammatory bowel disease intolerant or allergic to sulphasalazine. Aliment Pharmacol Ther. 1992;6:51-59.

Green JRB, Gibson JA, Kerr GD, et al. and The ABACUS Investigator Group. Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months. Aliment Pharmacol Ther. 1998;12:1207-1216.

Green JRB, Lobo AJ, Holdsworth CD, et al. and The ABACUS Investigator Group. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology. 1998;114:15-22.

Green JR, Mansfield JC, Gibson JA, Kerr GD, Thornton PC. A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Aliment Pharmacol Ther. 2002;16(1):61-68.

Green JR, Swan CH, Rowlinson A, et al. Short report: comparison of two doses of balsalazide in maintaining ulcerative colitis in remission over 12 months. Aliment Pharmacol Ther. 1992;6(5):647-652.

Hanauer SB. Balsalazide led to greater remission rates and tolerance than mesalamine in acute ulcerative colitis. Gut. 1999;44(4):455.

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Levine DS, Riff DS, Pruitt R, Wruble L, Koval G, Sales D, et al. A randomized, double-blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4) g in the treatment of active, mild to moderate ulcerative colitis. Am J Gastroenterology. 2002;97:1398-1407.

Mansfield JC, Giaffer MH, Cann PA, McKenna D, Thornton PC, Holdsworth CD. A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis. Aliment Pharmacol Ther. 2002;16(1):69-77.

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COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older. COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events (reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

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