Mesalamine Delayed Release Tablets

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Your pharmacist can provide more information about mesalamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Colitis (Symptoms, Types, and Treatments)
• Ulcerative Colitis

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti- inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [seeWarnings and Precautions (5.1)].

Azathioprine or 6-Mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders. If concomitant use of Mesalamine delayed-release tablets and azathioprineor 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with Mesalamine delayed-release tablets should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. Mesalamine delayed-release tablets is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.

Single oral doses of 5000 mg/kg mesalamine suspension in mice (approximately 4.2 times the recommended human dose of Mesalamine delayed-release tablets based on body surface area), 4595 mg/kg in rats (approximately 7.8 times the recommended human dose of Mesalamine delayed-release tablets based on body surface area) and 3000 mg/kg in cynomolgus monkeys (approximately 10 times the recommended human dose of Mesalamine delayed-release tablets based on body surface area) were lethal.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are approximately 0.97 and 2.0 times the 4.8 grams per day Mesalamine delayed-release tablet dose (based on body surface area). Mesalamine was not genotoxic in the Ames test, the Chinese hamster ovary cell chromosomal aberration assay, and the mouse micronucleus test. Mesalamine, at oral doses up to 480 mg/kg/day (about 0.97 times the recommended human treatment dose based on body surface area), was found to have no effect on fertility or reproductive performance of male and female rats.

Animal Toxicology and/or Pharmacology

In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity. (In the following, comparisons of animal dosing to recommended human dosing are based on body surface area and a 4.8 grams per day dose for a 60 kg person.)

Mesalamine causes renal papillary necrosis in rats at single doses of approximately 750 mg/kg to 1000 mg/kg (1.5 to 2.0 times the recommended human dose). Doses of 170 and 360 mg/kg/day (about 0.3 and 0.73 times the recommended human dose) 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 (approximately 4.1 times the recommended human dose) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis.

In dogs, single doses of 6000 mg (approximately 6.25 times the recommended human dose) of delayed- release mesalamine tablets resulted in renal papillary necrosis but were not fatal. Renal changes have occurred in dogs given chronic administration of mesalamine at doses of 80 mg/kg/day (0.5 times the recommended human dose).

Administration [see Dosage and Administration (2.1)]

•   Inform patients that if they are switching from a previous oral mesalamine therapy to Mesalamine delayed-release tablets to discontinue their previous oral mesalamine therapy and follow the dosing instructions for Mesalamine delayed-release tablets. One Mesalamine delayed-release 800 mg tablet is not substitutable for two mesalamine delayed-release 400 mg oral products.
•   Inform patients to take Mesalamine delayed-release tablets on an empty stomach, at least 1 hour before and 2 hours after a meal.
•   Instruct patients to swallow the Mesalamine delayed-release tablets whole, taking care not to break, cut, or chew the tablets, because the coating is an important part of the delayed-release formulation.
•   Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly.
•   Instruct patients to protect Mesalamine delayed-release tablets from moisture. Instruct patients to close the container tightly and to leave desiccant pouches in the bottle along with the tablets.

Renal Impairment

•   Inform patients that Mesalamine delayed-release tablets may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their physician [see Warnings and Precautions (5.1)].

Mesalamine-Induced Acute Intolerance Syndrome

•   Instruct patients to report to their physician if they experience new or worsening symptoms of cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash [see Warnings and Precautions (5.2)] .

Hypersensitivity Reactions

•   Inform patients of the signs and symptoms of hypersensitivity reactions, and advise them seek immediate medical care should signs and symptoms occur [see Warnings and Precautions (5.3)] .

Hepatic Failure

•   Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their physician if they experience such signs or symptoms [see Warnings and Precautions (5.4)].

Blood Disorders

•   Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their physician [see Drug Interactions (7.2), Use in Specific Populations (8.5)] .

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