About
COLAZAL

COLAZAL^® (balsalazide disodium) Capsules 750 mg is available only by prescription from your physician. COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC).

COLAZAL has been proven effective and well tolerated in clinical trials. COLAZAL has been shown to significantly improve patients' signs and symptoms of acute ulcerative colitis.^1,2

How COLAZAL Works in the Body

COLAZAL (balsalazide disodium) Capsules 750 mg delivers 5-aminosalicyclic acid (5-ASA), an anti-inflammatory drug, to the site of inflammation in the colon. Approximately 99% of an administered dose reaches the colon intact, where the 5-ASA works topically. 5-ASA appears to have multiple sites of impact on the immune system and the inflammatory process that characterizes ulcerative colitis.

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Who Should Not Take COLAZAL

COLAZAL is not for patients with hypersensitivity to aspirin-type products, or to any of the components of COLAZAL capsules or balsalazide metabolites.

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Precautions

General - Patients with pyloric stenosis (narrowing of the outlet from the stomach to the small intestine) may have prolonged gastric retention of COLAZAL capsules. Caution should be exercised in patients taking COLAZAL who have known renal dysfunction or renal disease.

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Drug Interactions

No drug interaction studies have been conducted for COLAZAL. However, the use of oral antibiotics could theoretically interfere with the release of mesalamine (the active component of COLAZAL) in the colon.

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Pregnant Woman and Nursing Mothers

No adequate and well-controlled studies were performed in pregnant women. COLAZAL is a pregnancy category B drug, which means that this drug should be used during pregnancy only if clearly needed.

It is not known whether COLAZAL is excreted in human milk. Caution should be exercised when COLAZAL is administered to a nursing woman.

Make sure to tell your doctor if you become pregnant or plan to become pregnant

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Children and Geriatric Patients

Safety and efficacy of COLAZAL in pediatric patients below the age of 5 years have not been established. No information is available for the geriatric population.

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Safety and Tolerability

In 4 controlled clinical trials, patients receiving a COLAZAL dose of 6.75 g/day most frequently reported headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%) and arthralgia (joint pain) (4%). Withdrawal from therapy due to adverse events was comparable among patients on COLAZAL and placebo (sugar pill). The safety and effectiveness of COLAZAL beyond 12 weeks have not been established.

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Dosage and Administration

Patients are advised to swallow COLAZAL capsules whole. The recommended adult prescription dose for the treatment of active ulcerative colitis is three 750 mg COLAZAL capsules, taken 3 times a day for a total daily dose of 6.75 g for a duration of 8 weeks. Some patients in clinical trials required treatment for up to 12 weeks.

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For More Information

Please ask your physician about COLAZAL. If you or your physician would like product information on COLAZAL, please call our customer service line at 1-866-669-SLXP (7597). View Complete Prescribing Information for COLAZAL (PDF format).

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References

1. 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.
2. Levine DS, Riff DS, Pruitt R, 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-modrate ulcerative colitis. Am J Gastoenterol. 2002;97:1398-1407.

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