Creon 5 (Pancrelipase Delayed-Release Minimicrospheres) Drug Information: Warnings and Precautions

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May 27, 2012

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Pancreatitis »

Pancreatitis facts*

*Pancreatitis facts Medically Edited by: Charles P. Davis, MD, PhD

Pancreatitis is inflammation of the pancreas, the organ that secretes digestive enzymes into the gastrointestinal tract; it also synthesizes and secretes insulin and glucagon.
Pancreatitis may be caused by gallstones (by blocking the pancreatic duct outlet), chronic alcohol use, trauma, medications, infections, tumors, and genetic abnormalities.
Acute pancreatitis with upper abdominal pain that is often severe and constant over several days, and may be accompanied by fever, nausea, vomiting, tachycardia, and abdominal swelling; severe cases can develop dehydration, low blood pressure, shock, organ failure, and death.
Acute pancreatitis is diagnosed preliminarily by the patient's history, physical exam and the levels of amylase and lipase in the blood (elevated in pancreatitis patients); other t...

Read the Pancreatitis article »

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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 (pancrelipase delayed-release minimicrospheres) 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.

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 (pancrelipase delayed-release minimicrospheres) 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 (pancrelipase delayed-release minimicrospheres) Capsules are administered to a nursing mother.

Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.