FAQs

How do COLAZAL® (balsalazide disodium) Capsules 750 mg work?

Balsalazide is delivered intact to the colon where it is cleaved by bacterial azoreductase enzymes to release mesalamine (5-aminosalicylic acid or 5-ASA), which is the therapeutically active portion of the molecule, and 5-aminobenzoyl-ß-alanine (an inactive carrier molecule). The mechanism of action of 5-ASA in inflammatory bowel disease is thought to be topical rather than systemic. Mucosal production of arachidonic acid metabolites both through the cyclooxygenase pathways and through the lipoxygenase pathways is increased in patients with chronic inflammatory bowel disease (IBD) and it is possible that a 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

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What is the dose of COLAZAL Capsules?

For the treatment of active ulcerative colitis the usual dose in adults is three 750 mg capsules, to be taken 3 times a day for a total daily dose of 6.75 g for a duration of 8 weeks. Some patients in the clinical trials required treatment for up to 12 weeks.

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How much 5-ASA is contained in a daily dose of COLAZAL?

The usual daily dose of COLAZAL Capsules (6.75 g) would contain an equivalent of 2.4 g of 5-ASA (mesalamine).

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How is COLAZAL supplied?

COLAZAL is supplied in bottles of 280 capsules that are beige in color containing 750 mg of balsalazide disodium and "CZ" imprinted in black. The NDC number for each bottle of 280 capsules is 65649-101-02.

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How should COLAZAL be stored?

COLAZAL should be stored at 25°C (77°F) with excursions permitted to 15-30°C (59-86°F).

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Can patients take COLAZAL who are allergic to salicylates?

COLAZAL is contraindicated in patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites.

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Can COLAZAL be used in pregnancy?

COLAZAL is Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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What are the most common adverse events for COLAZAL?

Over 1000 patients received treatment with COLAZAL in domestic and foreign clinical trials. In four controlled clinical trials, patients receiving COLAZAL 6.75 g/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 among patients on COLAZAL and placebo.

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