The prescribed dosage should be taken with each meal and snack or as directed by the physician. These can dissolve the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity.ĬREON® 5 Capsules are a pancreatic enzyme product prescribed to promote improved digestion of foods, especially fat. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel stricture should be investigated including evaluation of pancreatic enzyme therapy.ĬREON® 5 Capsules MINIMICROSPHERES® SHOULD NOT BE CRUSHED OR CHEWED or placed on foods having a pH greater than 5.5. 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. 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.
Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy if necessary. Post-gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy)ĭuctal obstruction from neoplasm (e.g., of the pancreas or common bile duct)ĬREON® 5 Capsules are contraindicated in the early stages of acute pancreatitis or in patients who are known to be hypersensitive to pork protein. The pancreatic enzymes catalyze the hydrolysis of fats to glycerol and fatty acids, protein into proteoses and derived substances and starch into dextrins and short chain sugars.ĬREON® 5 Capsules are indicated for patients with pancreatic exocrine insufficiency as is often associated with: The pancreatic enzymes in CREON® 5 Capsules are enteric-coated to resist gastric destruction or inactivation. The capsule imprinting ink contains dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium dioxide. The capsule shells contain gelatin, red iron oxide, titanium dioxide, yellow iron oxide and FD & C blue No. Inactive ingredients include dibutyl phthalate, dimethicone, hydroxypropylmethylcellulose phthalate, light mineral oil and polyethylene glycol.
Each CREON® 5 Capsule contains lipase 5,000 USP Units, protease 18,750 USP Units and amylase 16,600 USP Units.
CREON® 5 Capsules are orally administered and contain 124 mg of delayed-release MINIMICROSPHERES® of pancrelipase, which is of porcine pancreatic origin.