"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.
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.
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.
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