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5-aminosalicylic acid USP
5-Aminosalicylic Acid is thought to be the major therapeutically active part of the sulfasalazine molecule in the treatment of ulcerative colitis. Sulfasalazine is converted to equimolar amounts of sulfapyridine and 5-Aminosalicylic Acid by bacterial action in the colon. The mechanism of action of 5-Aminosalicylic Acid (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs), is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-Aminosalicylic Acid diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.
Each enteric coated delayed release tablet contains 5-Aminosalicylic Acid (Mesalamine) USP 400 mg.
Indications And Uses
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.
Dosage And Administration
For the treatment of mildly to moderately active 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. For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 gm daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.
Adverse reactions leading to withdrawal from 5-Aminosalicylic Acid delayed-release tablet included 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.
General: Patients with pyloric stenosis may have prolonged gastric retention of 5-Aminosalicylic Acid delayed-release tablet which could delay release of 5-Aminosalicylic Acid in the colon. Exacerbation of the symptoms of colitis has been reported in 3% of 5-Aminosalicylic Acid delayed-release tablet -treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of Asacol tablets as well as other 5-Aminosalicylic Acid products. Symptoms usually abate when 5-Aminosalicylic Acid delayed-release tablet is discontinued. Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to 5-Aminosalicylic Acid delayed-release tablet or to other compounds which contain or are converted to Mesalamine. Renal: Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure has been reported in patients taking 5-Aminosalicylic Acid delayed-release tablet as well as other compounds which contain or are converted to Mesalamine. Caution should be exercised when using 5-Aminosalicylic Acid delayed-release tablet (or other compounds which contain or are converted to 5-Aminosalicylic Acid or its metabolites) in patients with known renal dysfunction or history of renal disease.
Use In Pregnancy Lactation
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 gms daily. Caution should be exercised when 5-Aminosalicylic Acid delayed-release tablet is administered to a nursing woman.
There are no known drug interactions.
Store at controlled room temperature 20°- 25°C.
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.
Each box contains 5×10tablets in blister strip.