5-Aminosalicylic Acid delayed-release tablet is indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Anti-Tubercular Chemotherapeutics, Ulcerative Colitis
The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 gm for duration of 6 weeks.
5-Aminosalicylic Acid delayed-release tablet is contraindicated in patients with hypersensitivity to salicylates or to any of the components of the 5-Aminosalicylic Acid delayed-release tablet.
Diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
Pregnancy Category C. There are no adequate and well controlled studies of 5-Aminosalicylic Acid use in pregnant women. Limited published human data on 5-Aminosalicylic Acid show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. 5-Aminosalicylic Acid delayed-release tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as 5-Aminosalicylic Acid crosses the placenta. Lactation: 5-Aminosalicylic Acid and its N-acetyl metabolite are excreted into human milk. In published lactation studies, maternal 5-Aminosalicylic Acid doses from various oral and rectal formulations and products ranged from 500 mg to 3 gm daily. Caution should be exercised when 5-Aminosalicylic Acid delayed-release tablet is administered to a nursing woman.
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