Balsalazide Tablets

Limitations of Use:

Effectiveness of Balsalazide Disodium Tablets in the treatment of female patients was not demonstrated in clinical trials.

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.

DOSAGE FORMS & STRENGTHS

Balsalazide Disodium Tablets is available as yellow colored, oval shaped, biconvex, film-coated tablets debossed with “P” on one side and “840” on other side.

Contraindications

Balsalazide Disodium Tablets is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of balsalazide disodium Tablets.

Exacerbations of Ulcerative Colitis

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. In controlled clinical trials with balsalazide disodium in adults with ulcerative colitis, 7% of male patients reported exacerbation of the symptoms of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with balsalazide disodium.

Renal Impairment

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis and renal failure, has been reported in patients given products that release mesalamine in the gastrointestinal tract. Evaluate renal function prior to initiation of balsalazide disodium tablets therapy and periodically while on therapy. Exercise caution when using balsalazide disodium tablets in patients with known renal dysfunction or a history of renal disease.

Use in Hepatic Impairment

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Because balsalazide is converted to mesalamine, use caution and consider liver function testing when administering balsalazide disodium to patients with liver disease.