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 BRAND NAMES
 MECHANISM OF ACTION
Balsalzide, a mesalazine (5-ASA) prodrug, ulilizes azoreduction by colonic bacteria to achieve a sustained release of active 5-ASA throughout the colon.
The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.
- Treatment of mildly to moderately active ulcerative colitis, a disease of the colon and rectum in which the lining of the bowel becomes inflamed. Symptoms can include rectal bleeding, frequent diarrhea and abdominal pain
- Adults: three 750 mg capsules 3 times a day (6750 mg/day) with or without food for 8-12 weeks.
 DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg
Patients with hypersensitivity to salicylates or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.
 WARNINGS AND PRECAUTIONS
- Exacerbation of the symptoms of ulcerative colitis was reported. Observe patients closely for worsening of these symptoms while on treatment.
 PREGNANCY AND LACTATION
- Pregnancy Category B (US). Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
- Nursing Mothers: It is not known whether balsalazide disodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Balsalazide is administered to a nursing woman.
 SIDE EFFECTS
Most common adverse reactions are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia