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Balsalazide Tablets
  • Professionals
  • FDA PI

Balsalazide Tablets

Generic name: balsalazide disodium
Dosage form: tablet
Drug class:5-aminosalicylates

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

INDICATIONS & USAGE

Balsalazide Disodium Tablets is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.

Limitations of Use:

  • Effectiveness of Balsalazide Disodium Tablets in the treatment of female patients was not demonstrated in clinical trials [seeClinical Trials (14.1)].
  • Safety and effectiveness of Balsalazide Disodium Tablets therapy beyond 8 weeks have not been established.

DOSAGE & ADMINISTRATION

The dose is three 1.1 g Balsalazide Disodium Tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.

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