Generic Name and Formulations:
Balsalazide disodium 1.1g; tabs; contains sodium 126mg/tab.
Valeant Pharmaceuticals, Inc
Indications for GIAZO:
Treatment of mildly-to-moderately active ulcerative colitis in male patients. Limitations of use: effectiveness in treatment of female patients was not demonstrated. Safety and effectiveness of therapy beyond 8 weeks have not been established.
≥18yrs: 3 tabs twice daily; max 8 weeks.
<18yrs: not established.
Monitor for worsening symptoms of ulcerative colitis. Discontinue if acute intolerance syndrome is suspected. Known or history of renal impairment. Monitor renal function prior to initating and periodically during therapy. Hepatic impairment; consider monitoring LFTs during therapy. Elderly. Pregnancy (Cat. B). Nursing mothers.
In male patients: anemia, diarrhea, pharyngolaryngeal pain, UTI.