Safety
This information is intended for U.S. residents only.
In four controlled clinical trials, patients (n=259) receiving a COLAZAL® (balsalazide disodium) Capsules 750 mg 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.
Contraindications
COLAZAL is contraindicated in patients with hyper-sensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites.
Precautions
Of the 259 patients treated with COLAZAL 6.75 grams/day in controlled clinical trials of active disease, exacerbation of the symptoms of colitis, possibly related to drug use, has been reported by 3 patients.
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.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
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