Applies to the following strength(s): 750 mg ; 1.1 g
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Ulcerative Colitis - Active
Mildly to moderately active:
Capsules: 2250 mg orally 3 times a day for up to 8 weeks
In clinical trials, some patients required treatment for up to 12 weeks.
Male patients: 3.3 g orally twice a day for up to 8 weeks
Female patients: Effectiveness has not been established.
Usual Pediatric Dose for Ulcerative Colitis - Active
Mildly to moderately active:
5 years or older: 2250 mg orally 3 times a day or 750 mg orally 3 times a day for up to 8 weeks
Renal Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with known renal dysfunction or a history of renal disease.
Liver Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with liver disease. Liver function testing should be considered in such patients.
Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Exacerbation of the symptoms of ulcerative colitis has been reported in clinical trials. Patients should be observed closely for worsening of these symptoms while on treatment. Balsalazide should be discontinued promptly if acute intolerance syndrome is suspected.
Prolonged gastric retention of balsalazide capsules may occur in patients with pyloric stenosis.
Renal toxicity has been observed in patients given other mesalamine products. An evaluation of renal function prior to initiation of and periodically during balsalazide therapy is recommended.
A higher incidence of blood dyscrasias (i.e., neutropenia and pancytopenia) has been reported during uncontrolled clinical trials and postmarketing experience in patients 65 years or older receiving mesalamine-containing products. Since balsalazide is metabolized to mesalamine in the colon, blood cell counts should be monitored closely during therapy.
Safety and efficacy of balsalazide capsules beyond 12 weeks in adults and 8 weeks in pediatric patients have not been established. Safety and efficacy of balsalazide tablets beyond 8 weeks have not been established.
Safety and effectiveness of balsalazide capsules have not been established in pediatric patients less than 5 years of age. Safety and effectiveness of balsalazide tablets have not been established in pediatric patients (less than 18 years of age).
Data not available
The contents of the capsule may be sprinkled over applesauce.
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- Drug class: 5-aminosalicylates