Balsalazide Disodium

Generic Name: balsalazide disodium

Over-the-Counter (OTC)

Brand Names:

Balsalazide Disodium

Balsalazide disodium capsules contain 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug.

Overview

Balsalazide disodium capsules contain 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug.

Uses

Balsalazide is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Dosage

Adult dose is three 750 mg balsalazide disodium capsules 3 times a day (6.75 g/day) with or without food for 8 weeks. Some adult patients required treatment for up to 12 weeks.

Side Effects

Most common adverse reactions (incidence 3% or greater) are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia.

Interactions

The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of renal reactions.

Warnings

Contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any components. Renal impairment may occur; assess renal function at the beginning of treatment and periodically during treatment.

Pregnancy

Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage

Store at 20 to 25C (68 to 77F); excursions permitted between 15 and 30C (59 and 86F).

Frequently Asked Questions

What is Balsalazide Disodium used for?

Balsalazide is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

What are the side effects of Balsalazide Disodium?

Most common adverse reactions (incidence 3% or greater) are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia.

Can I take Balsalazide Disodium during pregnancy?

Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

What are the important warnings for Balsalazide Disodium?

Contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any components. Renal impairment may occur; assess renal function at the beginning of treatment and periodically during treatment.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.