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INDICATIONS

CREON® (pancrelipase) Delayed Release Capsules is a pancrelipase which is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Important Safety Information

  • Fibrosing colonopathy, is associated with high-dose use of pancreatic enzyme replacement in the treatment of cystic fibrosis patients. Exercise caution when doses of CREON exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day).

  • To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed or retained in the mouth. CREON should always be taken with food.

  • Porcine-derived pancreatic enzyme products contain purines. Caution should be exercised when prescribing CREON to patients with gout, renal impairment, or hyperuricemia.

  • There is theoretical risk of viral transmission with all pancreatic enzyme products including CREON.

  • Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

  • Adverse reactions that occurred in at least 2 cystic fibrosis patients (greater than or equal to 4%) receiving CREON are vomiting, dizziness and cough.

  • Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON are, hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis.

  • CREON is not interchangeable with any other pancrelipase product.

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