Should hypersensitivity occur during the course of treatment, discontinue medication and treat symptomatically. Cases of intestinal stricture and blockage requiring surgical decompression have been reported in cystic fibrosis patients, especially in patients with a history of intestinal complications such as meconium ileus equivalent, short bowel syndrome, surgery or Crohn's disease, who were taking high lipase activity pancreatic enzyme preparations (i.e., those labeled as containing more than 20,000 lipase units per capsule). If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered including evaluation of pancreatic enzyme therapy.

General

TO PROTECT ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, the capsules may be carefully opened and the microspheres shaken onto a small quantity of soft food such as applesauce, gelatin, jelly, pudding, etc., which does not require chewing, and swallowed immediately, followed by a glass of water or juice to ensure complete swallowing. Prolonged contact of the microspheres with foods having a pH greater than 5.5 can weaken the integrity of the protective enteric coat and compromise the potency of the enzymes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential of PANCRECARBâ (pancrelipase) delayed-release capsules.

Pregnancy/Reproduction

Pregnancy Category C. Diethyl phthalate, an enteric coating component of PANCRECARBâ (pancrelipase) delayed-release capsules has been shown to be teratogenic in rats following high intraperitoneal dosing. When this coating was given orally to rats up to 100 times the human dose, however, no teratogenic or embryocidal effects were observed. There were no adequate and well-controlled studies in pregnant women. PANCRECARBâ (pancrelipase) delayed-release capsules should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Nursing Mothers

It is not known whether pancrelipase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PANCRECARBâ is administered to a nursing mother.

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