Asacol (mesalamine) Delayed-Release Tablets contain acrylic based resin, Eudragit S (methacrylic acid and methyl methancrylate copolymer), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. About a year ago, I observed that the First Circuit in In re Asacol Antitrust Litigation had constrained plaintiffs’ ability to rely on affidavits to prove injury-in-fact. At Week 6, 56% of the patients in the low dosage group, and 55% of the patients in the high dosage group achieved success based on the PUCAI; 46% of the patients in the low dosage group and 43% of the patients in the high dosage group achieved complete response.The high dosage regimen is not recommended because it was not more effective than the low dosage regimen In a randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 months’ duration in 264 patients (Study 4), patients received Asacol dosages of 0.8 grams/day (400 mg twice a day; n = 90) and 1.6 grams/day (400 mg four times a day; n = 87), compared to placebo four times a day (n = 87). Do not take extra medicine to make up the missed dose.Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Ask your doctor before using an antacid, and use only the type your doctor recommends. Renal changes have occurred in dogs given chronic administration of mesalamine at doses of 80 mg/kg/day (1.1 times the recommended human dose based on body surface area).Two placebo-controlled studies (Studies 1 and 2) have demonstrated the efficacy of Asacol in patients with mildly to moderately active ulcerative colitis.In one randomized, double-blind, multi-center, placebo-controlled clinical trial of 6 weeks’ duration in 158 patients (Study 1), patients received Asacol dosages of 1.6 grams/day (800 mg twice a day; n=53) and 2.4 grams/day (800 mg three times a day; n=53), compared to placebo (n=52). Monitor patients for worsening of these symptoms while on treatment. The court distinguished its Nexium decision for two reasons: (1) unlike in Nexium, in Asacol a more than “de minimis” number of class members were uninjured; and (2) unlike in Nexium, in Asacol the defendant came forward with Discontinue Asacol if an alternative etiology for the signs or symptoms cannot be established.There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine.

At higher dosages (greater than or equal to 500 mg/kg/day, approximately 194 times the human dose based on body surface area), additional effects, including cryptorchidism, hypospadias, atrophy or agenesis of sex accessory organs, testicular injury, reduced daily sperm production, permanent retention of nipples, and decreased anogenital distance are noted. In Nexium, Judge Kayatta wrote, the appeals court suggested the sworn affidavit approach to ascertaining class membership without litigation below on that issue. Important information. Doses of 170 and 360 mg/kg/day (about 0.7 and 1.5 times the recommended human dose based on body surface area) given to rats for six months produced papillary necrosis, papillary edema, tubular degeneration, tubular mineralization, and urothelial hyperplasia.In mice, oral doses of 4000 mg/kg/day mesalamine (approximately 8 times the recommended human dose based on body surface area) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis.In dogs, single doses of 6000 mg (approximately 8 times the recommended human dose based on body surface area) of delayed-release mesalamine tablets resulted in renal papillary necrosis but were not fatal. Indeed, it noted, a challenged affidavit would not prevail at a summary judgment hearing, let alone a Seventh Amendment trial. )Mesalamine causes renal papillary necrosis in rats at single doses of approximately 750 mg/kg to 1000 mg/kg (approximately 3 to 4 times the recommended human dose based on body surface area). The serious adverse reactions consisted of sinusitis, adenovirus infection, and pancreatitis in one patient each in the low dosage group. In re Asacol, 907 F.3d at 52. Doses were administered every 12 hours.The proportion of patients who achieved success based on the Truncated Mayo Score (TM-Mayo) (based on the stool frequency and rectal bleeding subscales of the Mayo Score) and based on the PUCAI was measured after 6 weeks of treatment.