Oral 5-aminosalicyclic acid in children with colonic chronic inflammatory bowel disease: clinical and pharmacokinetic experience

Abstract

Five children between the ages of 10 and 17 years with chronic inflammatory bowel disease with involvement of colon had intolerance to sulfasalazine, and desensitization trials had failed in them. In addition, they were steroid dependent. Therefore treatment was tried with an oral 5-aminosalicylic acid (5-ASA) preparation coated with the pH sensitive polymer Asacol. Three of these patients responded to the new drug and were weaned off the steroids. However, the other two patients developed repeated side effects from the medication. Plasma levels and urinary excretion of 5-ASA and its major metabolite in four of these patients were determined and were noted to be similar to those in the adults. Range of variable steady state plasma level of 5-ASA was 0.1-5 mg/L and of its acetyl-metabolite (Ac-5-ASA) was 1-8 mg/L.