Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Important Dosing Information

• CREON is a mixture of enzymes including lipases, proteases, and amylases, and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion.
• Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
• Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. 
• The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.
• Do not substitute other pancreatic enzyme products for CREON. When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Recommended Dosage

Adult and Pediatric Patients Greater than 12 Months: The recommended initial starting dosage is:

• 500 lipase units/kg/meal for adult and pediatric patients 4 years and older.
• 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 
• 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years.
• Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented effective by fecal fat measures or improvement of malabsorption.

Pediatric Patients Birth to 12 Months: The recommended dosage is 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding.

Preparation and Administration Instructions

• Swallow capsules whole. For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt).
• Do not crush or chew CREON capsules or capsule contents.
• Consume sufficient liquids to ensure complete swallowing of CREON.

See the full prescribing information for additional information on administering to pediatric patients birth to 12 months.

Most Common Adverse Reactions

Cystic fibrosis adult and pediatric patients:

• 7 years and older (≥4%): vomiting, dizziness, cough.
• 4 months to 6 years (6%): vomiting, irritability, decreased appetite.

Chronic pancreatitis or pancreatectomy patients:

• Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis.

None

• Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.
• Irritation of the Oral Mucosa: May occur due to loss of protective enteric coating on the capsule contents.
• Hyperuricemia: Reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
• Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded.
• Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.