"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 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 potency lipase 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 the evaluation of pancreatic enzyme therapy. Patients receiving lipase dose of > 2,500 USP units per kilogram per meal should be re-evaluated and the lipase dose either be reduced by 50% or titrated down gradually to the lowest clinically effective dose as determined by 72-hour fecal fat excretion.
GENERAL - TO PROTECT ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED.
The microsphere-containing capsules should be swallowed with liquids at the start of a meal. Where swallowing of capsules is difficult, the capsules may be carefully opened and the microspheres shaken into a small quantity of soft food such as applesauce, jelly, jello, 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 with PANCRECARB® (pancrelipase) delayed-release capsules.
Pregnancy Category C. Diethylphthalate, an enteric coating component of PANCRECARB® (pancrelipase) have 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/20/2009
Additional Pancrecarb Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.