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PRECAUTIONS

General

Large doses of delayed release pancreatic enzyme preparations taken by patients with cystic fibrosis have been associated with fibrosing colonopathy (colonic stricture). While COTAZYM® (pancrelipase capsules, USP) is an immediate release product and such products have not generally been associated with the lesion, the dose recommended should not be exceeded unless justified by individual patient need and response (see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS ). If capsules must be opened for any reason, care should be taken that the powder is not inhaled or spilled on hands; it may cause serious allergic reaction or be irritating to the skin or mucous membranes. A mask and gloves should be worn while handling opened capsules.

Folic acid supplementation during pregnancy is important. Daily oral supplementation with folic acid before conception and during pregnancy can substantially reduce the occurrence of neural tube defects (anencephaly and spina bifida). Women should take folic acid if they are pregnant, or are thinking of becoming pregnant during treatment with COTAZYM®.

Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe COTAZYM® (pancrelipase capsules, USP):

Taking the Capsules

Patients should be instructed not to increase their COTAZYM® (pancrelipase capsules, USP) dose without consulting their physician. If it becomes necessary to open the COTAZYM® capsules, inhalation of the powder or contact with the skin or mucous membranes should be avoided. It is suggested mask and gloves be worn when opening capsules. COTAZYM® should not be taken by patients with known hypersensitivity to antigens of porcine origin. Sensitive individuals may experience allergic reactions.

Folic acid supplementation during pregnancy is important. Daily oral supplementation with folic acid before conception and during pregnancy can substantially reduce the occurrence of neural tube defects (anencephaly and spina bifida). Women should take folic acid if they are pregnant, or are thinking of becoming pregnant during treatment with COTAZYM®.

Concomitant Medication

Patients should be advised not to take COTAZYM® (pancrelipase capsules, USP) together with a combination of calcium carbonate and magnesium hydroxide. Calcium carbonate and magnesium hydroxide may be found in certain antacids. Calcium carbonate can also be found in certain calcium or mineral supplements. COTAZYM® may interfere with the absorption of folic acid and iron. Patients should consult with their physician if taking folic acid or iron containing preparations.

Pregnancy

COTAZYM® (pancrelipase capsules, USP) may interfere with the absorption of folic acid. Folic acid supplementation during pregnancy is important. Daily oral supplementation with folic acid before conception and during pregnancy can substantially reduce the occurrence of neural tube defects (anencephaly and spina bifida). Patients should be advised to notify their physician if they are pregnant or are thinking of becoming pregnant during treatment with COTAZYM® (pancrelipase capsules, USP).

Nursing

Patients should be advised to notify their physician if they are breast-feeding an infant.

Drug Interactions

Antacids containing calcium carbonate and magnesium hydroxide should not be taken concurrently with pancrelipase. The combination of calcium carbonate and magnesium hydroxide with pancrelipase may precipitate glycine-conjugated bile acids and may form calcium and magnesium fatty acid soaps, causing a decrease in fat absorption and thus an increase in steatorrhea.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term animal studies for carcinogenesis and studies evaluating the potential for impairment of fertility of mutagenesis have not been performed with COTAZYM® (pancrelipase capsules, USP).

Pregnancy

Pregnancy Category C

Animal reproductive studies have not been conducted with COTAZYM® (pancrelipase capsules, USP). It is not known whether COTAZYM® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. COTAZYM® should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known if COTAZYM® (pancrelipase capsules, USP) is excreted in human milk.

Because many products are excreted in human milk, caution should be exercised when COTAZYM® is administered to nursing mothers.

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