Ulcerative colitis, Ulcerative proctitis, Crohn's disease.
Usual Adult Dose for Ulcerative Colitis - Active ORAL: 250 and 500 mg capsules: 1 g orally 4 times a day Duration of therapy: Up to 8 weeks 400 mg tablets: 800 mg orally 3 times a day Duration of therapy: 6 weeks 400 mg delayed release capsules: 800 mg orally 3 times a day Duration of therapy: 6 weeks 800 mg delayed release tablets: 1600 mg orally 3 times a day Duration of therapy: 6 weeks 1200 mg tablets: 2.4 to 4.8 g orally once a day with food Uses: Treatment of mildly to moderately active ulcerative colitis and induction of remission of ulcerative colitis. Usual Adult Dose for Ulcerative Colitis - Maintenance 375 mg extended release capsules: 1.5 g (4 capsules) orally once a day in the morning 400 and 800 mg tablets and capsules: 1.6 g orally daily in divided doses 1200 mg tablets: 2.4 g (2 tablets) orally once a day with food. Usual Adult Dose for Ulcerative Proctitis Suppository: 1 suppository (1000 mg) rectally once a day at bedtime Duration of therapy: 6 weeks
Mesalamine Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication. Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. The patient’s history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage. In the literature one patient previously sensitive to sulfasalazine was rechallenged with 400 mg oral Mesalamine; within eight hours she experienced headache, fever, intensive abdominal colic, profuse diarrhea and was readmitted as an emergency. She responded poorly to steroid therapy and two weeks later a pancolectomy was required. Although renal abnormalities were not noted in the clinical trials with Mesalamine Rectal Suspension Enema, the possibility of increased absorption of Mesalamine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on Mesalamine Rectal Suspension Enema, especially those on concurrent oral products which liberate Mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), and creatinine studies. In a clinical trial most patients who were hypersensitive to sulfasalazine were able to take Mesalamine enemas without evidence of any allergic reaction. Nevertheless, caution should be exercised when Mesalamine is initially used in patients known to be allergic to sulfasalazine. These patients should be instructed to discontinue therapy if signs of rash or fever become apparent.
Commonly reported side effects of mesalamine include: headache. Other side effects include: abdominal cramps, abdominal distress, abdominal pain, influenza, nausea, constipation, dyspepsia, skin rash, vomiting, and flatulence.
Pregnancy Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well-controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether Mesalamine or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
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