COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older. Safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
Important Safety Information for COLAZAL (balsalazide disodium) Capsules
COLAZAL (balsalazide disodium) Capsules are contraindicated in patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.
Exacerbation of the symptoms of ulcerative colitis was reported in both adult and pediatric patients. Observe patients closely for worsening of these symptoms while on treatment.
Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL capsules.
Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering COLAZAL to patients with known renal dysfunction or a history of renal disease.
Most common adverse reactions (incidence >3%) are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. Adverse reactions in children were similar.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.
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