Mesalamine Extended-Release Capsules

Each APRISO capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an anti-inflammatory drug. The structural formula of mesalamine is:

Molecular Weight: 153.14

Molecular Formula: C7H7NO3

Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above.

The inactive ingredients of APRISO capsules are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, simethicone emulsion ethyl acrylate/methyl methacrylate copolymer nonoxynol 100 dispersion, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, aspartame, anhydrous citric acid, povidone, vanilla flavor, and edible black ink.

APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

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.

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

To make sure you can safely take mesalamine, tell your doctor if you have any of these other conditions:

• a stomach condition called pyloric stenosis;
• a history of allergy to sulfasalazine (Azulfidine);
• a heart condition such as congestive heart failure;
• kidney disease; or
• liver disease.

FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Mesalamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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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