Indication for GIAZO
GIAZO® (balsalazide disodium) is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in male patients 18 years of age and older. Effectiveness in female patients was not demonstrated in clinical trials. Safety and effectiveness of GIAZO beyond 8 weeks have not been established.
Important Safety Information about GIAZO
Do not take GIAZO® (balsalazide disodium) tablets if you experience an allergic reaction to salicylates, aminosalicylates, or to any of the components of GIAZO tablets.
Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.
Before GIAZO treatment and periodically throughout treatment, your kidney function should be evaluated by your doctor. If you have any history of kidney disease, talk to your doctor before taking GIAZO.
If you have liver disease, talk to your doctor before taking GIAZO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.
The effectiveness of GIAZO in female patients was not demonstrated in clinical studies. The safety and effectiveness of GIAZO beyond 8 weeks have not been established.
Talk to your doctor if you need to control sodium intake. The recommended dose of GIAZO (6.6 g/day) provides about 756 mg of sodium per day.
The most common side effects occurring in at least 2% of male patients in the clinical study were anemia (iron deficiency), diarrhea, pharyngolaryngeal (mouth and throat) pain, urinary tract infection, arthralgia (joint pain), insomnia (sleeplessness), and muscle pain.
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 GIAZO.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.