COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older.
Ulcerative colitis is characterized by inflammation and ulceration of the lining of the colon. The cause is unknown, and it usually occurs in people aged 15 to 35 years, with a second peak among people aged 55 to 60 years. Symptoms of UC may include bloody diarrhea, rectal bleeding, bowel urgency, abdominal pain and tenderness, nausea and vomiting, loss of appetite, weight loss, and fever.
COLAZAL is a UC treatment that has been clinically proven to provide complete relief of symptoms in an average of 10 days.1 Unlike other kinds of ulcerative colitis medications, COLAZAL delivers 99% of its active ingredient to the colon to start working to relieve UC symptoms.2
Important Safety Information about COLAZAL
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.
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
Please see complete Prescribing Information for COLAZAL.
References: 1. Green JR, Lobo AJ, Holdsworth CD, et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology. 1998;114:15-22.
2. COLAZAL [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2012.
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