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Creon (Amylase / Lipase / Protease) - Warnings and Precautions

 
 



WARNINGS

Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy if necessary.

Strictures in the ileo-cecal region and/or ascending colon have been reported in cystic fibrosis patients treated with high doses of high-potency pancreatic enzyme supplements containing 20,000 or greater USP units of lipase per capsule. The underlying mechanism is unknown, but caution should be exercised when doses in excess of 6,000 USP units lipase per kg per meal fail to resolve symptoms, especially in patients with a history of intestinal complications such as meconium ileus equivalent, short bowel syndrome, surgery or Crohn's disease. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel stricture should be investigated including evaluation of pancreatic enzyme therapy.

PRECAUTIONS

CREON® 5 Capsules MINIMICROSPHERES® SHOULD NOT BE CRUSHED OR CHEWED or placed on foods having a pH greater than 5.5. These can dissolve the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity.

INFORMATION FOR PATIENTS

CREON® 5 Capsules are a pancreatic enzyme product prescribed to promote improved digestion of foods, especially fat. The prescribed dosage should be taken with each meal and snack or as directed by the physician. The capsules can be swallowed whole, or the contents poured on soft, bland food. Care should be taken to avoid chewing or crushing of the capsule contents, which can result in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity. Patients should maintain adequate fluid intake. The prescribed dose range should not be exceeded without calling your doctor.

The most common adverse reactions involve the stomach and intestine including diarrhea, nausea, vomiting, bloating, constipation, stomach cramps or pain. If these symptoms are persistent, contact your doctor.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY, CATEGORY C

Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CREON® 5 Capsules should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CREON® 5 Capsules are administered to a nursing mother.

Page last updated: 2006-02-02

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