The active ingredient, diphenoxylate, metabolizes in the body to create an opioid compound that acts in the intestines and in the brain. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their elimination half-lives following administration of Asacol.In a dose-ranging pharmacokinetic study evaluating 30, 60 and 90 mg/kg/day doses of Asacol administered twice daily for four weeks, the mean average concentration (CIn a study in pediatric ulcerative colitis patients (Study 3), mean plasma concentrations of mesalamine (based on sparse sampling) were 820 to 988 ng/mL at the low dosage level (that is, 1.2, 2 or 2.4 grams/day based on body weight strata of 17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg, respectively).Mesalamine was not carcinogenic at dietary dosages of up to 480 mg/kg/day in rats and 2000 mg/kg/day in mice, which are about 2.9 and 6.1 times of the maximum recommended maintenance dosage of Asacol of 1.6 grams/day or 26.7 mg/kg/day, based on 60 kg body weight, respectively, based on body surface area.Mesalamine was negative in the Ames assay for mutagenesis, negative for induction of sister chromatid exchanges (SCE) and chromosomal aberrations in Chinese hamster ovary cells Mesalamine, at oral dosages up to 480 mg/kg/day (about 1.9 times the recommended human treatment dosage on a body surface area basis), was found to have no effect on fertility or reproductive performance of male and female rats.In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity. Adverse reactions leading to study withdrawal in patients using Asacol included (each in one patient): anxiety, stomatitis and asthenia.In addition to the adverse reactions listed in Table 2, the following occurred at a frequency of 2% or greater in patients who received Asacol in Study 4: abdominal enlargement, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, nervousness, paresthesia, hemorrhoids, tenesmus, urinary frequency, and vision abnormalities.In addition to the adverse reactions reported above in clinical trials involving Asacol, the adverse reactions listed below have been identified during post-approval use of Asacol and other mesalamine-containing products. We comply with the HONcode standard for trustworthy health information - Success based on PUCAI was defined as either partial response (PUCAI reduction of greater than or equal to 20 points from Baseline to Week 6 with Week 6 score greater than or equal to 10) or complete response (PUCAI less than 10 at Week 6).There were 41 patients in the low dosage group and 41 patients in the high dosage group who received at least one dose of Asacol; 36 patients in each dosage group completed the study. The condition can include partial incontinence, in which a person loses only a small amount of liquid waste, to complete incontinence, in which the entire bowel movement cannot be controlled.
Treatment involves a combination of medication, biofeedback, and exercise.Travelers' diarrhea is generally contracted by eating contaminated food or drinking contaminated water. Unabsorbed mesalamine is excreted in feces.After intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Patients were considered treatment failures if they did not achieve success or dropped out due to adverse reaction or lack of efficacy.At Week 6, 73% of the patients in the low dosage group, and 70% of the patients in the high dosage group achieved success based on the TM-Mayo; 34% of the patients in the low dosage group and 43% of the patients in the high dosage group achieved complete response.
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