Drug Detail:Balsalazide (Balsalazide [ bal-sal-a-zide ])
Drug Class: 5-aminosalicylates
Usual Adult Dose for Ulcerative Colitis - Active
Oral capsules:
Usual dose: Three 750 mg capsules orally 3 times a day for up to 8 weeks
- Some patients in the clinical trials required up to 12 weeks of treatment.
- Safety and efficacy beyond 12 weeks have not been established.
GIAZO(R) tablets; male patients:
Three 1.1 gram tablets orally twice a day, with or without food, for up to 8 weeks
- Effectiveness in female patients was not demonstrated in clinical trials.
- Safety and efficacy beyond 8 weeks have not been established.
Use(s): Treatment of mildly to moderately active ulcerative colitis.
Usual Pediatric Dose for Ulcerative Colitis - Active
5 years and older, oral capsules:
Three 750 mg capsules orally 3 times a day for up to 8 weeks
OR
One 750 mg capsule orally 3 times a day for up to 8 weeks
Comments:
- Safety and efficacy beyond 8 weeks have not been established
Use(s): Treatment of mildly to moderately active ulcerative colitis.
Renal Dose Adjustments
Use with caution.
- Evaluate renal function prior to therapy and periodically while on therapy.
Liver Dose Adjustments
Use with caution.
- Consider liver function testing in patients with liver disease.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to any of the ingredients, salicylates, aminosalicylates or any of their metabolites
Safety and efficacy have not been established in patients younger than 5 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Capsules may be opened and sprinkled on applesauce; this should be swallowed immediately and not stored for future use.
- If capsules are opened for sprinkling, the medication has a natural color variation from orange to yellow, and it may stain the teeth and/or tongue.
Storage requirements:
- Store at controlled room temperature.
