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. Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. * At Least 2% of Patients in the Mesalamine Delayed Release Tablets Group and at a Rate Greater than PlaceboA randomized, double-blind, 6-week study of 2 dosage levels of mesalamine delayed-release 400 mg tablets (Study 3) was conducted in 82 pediatric patients 5 to 17 years of age with mildly to moderately active ulcerative colitis. Below is a description of the adverse reactions of mesalamine delayed-release tablets in these adequate and well-controlled studies.Clinical studies supporting mesalamine delayed-release tablets use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in adults with mildly to moderately active ulcerative colitis (Studies 1 and 2), and one 6-week, randomized, double-blind, study of 2 dosage levels in children with mildly to moderately active ulcerative colitis (Study 3). In addition, significantly more patients in the mesalamine delayed release tablets 2.4 grams per day group showed improvement in rectal bleeding and stool frequency. Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, … A generic version of Delzicol has been approved by the FDA.       Available for Android and iOS devices. Delayed-release capsules (containing four 100 mg tablets): 400 mg (Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL capsules (• Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.The recommended dosage of DELZICOL in adults is 1.6 grams (four 400 mg capsules) daily in two to four divided doses.DELZICOL (mesalamine) delayed-release capsules are clear capsules and imprinted “WC 400mg” in black ink.


Five patients were withdrawn from the study due to adverse reactions: 3 (7%) in the low dosage group (1 patient each with adenovirus infection, sclerosing cholangitis, and pancreatitis) and 2 patients (5%) in the high dosage group (1 patient with increased amylase and increased lipase, and 1 patient with upper abdominal pain).
The proportion of patients who achieved success based on the Truncated Mayo Score (TM-Mayo) (based on the stool frequency and rectal bleeding subscores of the Mayo Score) and based on the PUCAIwas measured after 6 weeks of treatment. In total, mesalamine delayed-release 400 mg tablets have been evaluated in 2690 patients with ulcerative colitis in controlled and open-label trials. 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. The 1.6 grams per day dosage regimen is not recommended because it did not produce consistent evidence of effectiveness [see In a second randomized, double-blind, placebo-controlled clinical trial of 6 weeks’ duration in 87 patients (Study 2), patients received mesalamine delayed release tablets of 1.6 grams per day (400 mg four times a day; n=11) and 4.8 grams per day (1.2 grams four times a day; n=38), compared to placebo four times a day (n=38). Updated Most Common Adverse Reactions Reported in Study 1 for the Treatment of Mild to Moderate Ulcerative Colitis in Adults*Table 3. No evidence of 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.

Success based on TM-Mayo was defined as either partial response (improvement from baseline in stool frequency or rectal bleeding subscores with no worsening in the other) or complete response (both stool frequency and rectal bleeding subscores equal 0). The safety and effectiveness of DELZICOL for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. After oral dosing, the median terminal tIn a dose-ranging pharmacokinetic study evaluating 30, 60 and 90 mg/kg per day doses of mesalamine delayed-release 400 mg tablets administered twice daily for four weeks, the mean CIn a study evaluating mesalamine delayed-release tablets 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 dose 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). Il est également utilisé pour prévenir et soigner les nausées et les vomissements qui surviennent après une intervention chirurgicale. Evaluate the risks and benefits of using DELZICOL in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.