Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING CREON (pancrelipase) delayed-release capsules, containing tan-colored enteric-coated pancrelipase spheres, are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase Two-piece hypromellose capsule, white opaque cap imprinted “CREON 1203”, white opaque body Bottles of 70 0032-0045-70 0032-1203-70 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-0046-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-1206-01 Bottles of 250 0032-1206-07 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase Two-piece hypromellose capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-0047-70 Two-piece gelatin capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-1212-01 Bottles of 250 0032-1212-07 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-2636-01 Bottles of 240 0032-2636-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-1224-01 Bottles of 250 0032-1224-07 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase Two-piece hypromellose capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-2637-01 Bottles of 240 0032-2637-70 Two-piece gelatin capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-3016-13 Bottles of 250 0032-3016-28 Storage and Handling Store CREON at room temperature, 15°C to 25°C (59°F to 77°F), and protect from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F to 104°F) for up to 30 days. Discard CREON if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture. Keep the desiccant in the bottle if present . Store and dispense CREON in the original container.; NDC 0032-0045-70 70 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0045-70 70 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.; NDC 0032-0046-70 100 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0046-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.; NDC 0032-0047-70 100 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0047-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.; NDC 0032-1203-70 70 Delayed-Release Capsules Pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1203-70 70 Delayed-Release Capsules Pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-1206-01 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1206-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-1212-07 250 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1212-07 250 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-1224-01 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1224-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-2636-70 240 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-2636-70 240 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-2637-70 240 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-2637-70 240 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie; NDC 0032-3016-13 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-3016-13 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- 16 HOW SUPPLIED/STORAGE AND HANDLING CREON (pancrelipase) delayed-release capsules, containing tan-colored enteric-coated pancrelipase spheres, are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase Two-piece hypromellose capsule, white opaque cap imprinted “CREON 1203”, white opaque body Bottles of 70 0032-0045-70 0032-1203-70 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-0046-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-1206-01 Bottles of 250 0032-1206-07 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase Two-piece hypromellose capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-0047-70 Two-piece gelatin capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-1212-01 Bottles of 250 0032-1212-07 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-2636-01 Bottles of 240 0032-2636-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-1224-01 Bottles of 250 0032-1224-07 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase Two-piece hypromellose capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-2637-01 Bottles of 240 0032-2637-70 Two-piece gelatin capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-3016-13 Bottles of 250 0032-3016-28 Storage and Handling Store CREON at room temperature, 15°C to 25°C (59°F to 77°F), and protect from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F to 104°F) for up to 30 days. Discard CREON if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture. Keep the desiccant in the bottle if present . Store and dispense CREON in the original container.
- NDC 0032-0045-70 70 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0045-70 70 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.
- NDC 0032-0046-70 100 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0046-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.
- NDC 0032-0047-70 100 Delayed-Release Capsules Rx only pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. NDC 0032-0047-70 100 Delayed-Release Capsules Rx only pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient.
- NDC 0032-1203-70 70 Delayed-Release Capsules Pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1203-70 70 Delayed-Release Capsules Pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 3,000 USP Units Protease 9,500 USP Units Amylase 15,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-1206-01 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1206-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 6,000 USP Units Protease 19,000 USP Units Amylase 30,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-1212-07 250 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1212-07 250 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 12,000 USP Units Protease 38,000 USP Units Amylase 60,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-1224-01 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-1224-01 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-2636-70 240 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-2636-70 240 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 24,000 USP Units Protease 76,000 USP Units Amylase 120,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-2637-70 240 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-2637-70 240 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Unites Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
- NDC 0032-3016-13 100 Delayed-Release Capsules pancrelipase CREON ® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie NDC 0032-3016-13 100 Delayed-Release Capsules pancrelipase CREON® Delayed-Release Capsules DOSE BY LIPASE UNITS Lipase 36,000 USP Units Protease 114,000 USP Units Amylase 180,000 USP Units Each delayed-release capsule contains pancrelipase in enteric-coated spheres. Dispense enclosed Medication Guide to each patient. Rx only abbvie
Overview
Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows: 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.
Indications & Usage
CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
Dosage & Administration
Important Dosing Information ( 2.1 ) 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. ( 5.1 ) 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 ( 2.2 ) 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 ( 2.3 ) 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. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months. 2.1 Important Dosing Information CREON is a mixture of enzymes including lipases, proteases, and amylases. CREON dosing is based on lipase units. Use either an actual body weight or fat ingestion-based dosing scheme. Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days. 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 [see Warnings and Precautions ( 5.1 )] . 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 CREON 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. 2.2 Recommended Dosage Adult and Pediatric Patients Greater than 12 Months of Age The recommended oral initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years of age 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 of age. If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/gram of fat ingested/day. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Pediatric Patients Birth to 12 Months of Age The recommended oral dosage is 3,000 lipase units per 120 mL of formula or per breast-feeding. 2. 3 Preparation and Administration Instructions Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following: Take CREON during meals and snacks. If a dose is missed, take the next dose with the next meal or snack. Swallow capsules whole. For patients who are unable to swallow intact capsules, carefully open the capsules and sprinkle the entire contents on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt). Consume the entire mixture immediately. Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids (water or juice) to ensure complete swallowing of CREON [see Warnings and Precautions ( 5.2 )] . Instruct caregivers of pediatric patients birth to 12 months of age of the following: Immediately prior to each breast-feeding session or each administration of 120 mL of formula, carefully open one CREON capsule (containing 3,000 USP units of lipase) and administer the entire contents using one of the following two methods: Sprinkle on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt) being careful not to crush the capsule contents. The entire mixture should be given to the infant immediately. Sprinkle the capsule contents directly into the infant’s mouth. Immediately administer additional breast milk or formula after CREON to ensure complete swallowing of the capsule contents. Do not mix CREON capsule contents directly into a bottle of breast milk or formula. Do not crush CREON capsule contents, and visually inspect the infant’s mouth to ensure that no drug is retained in the mouth [see Warnings and Precautions ( 5.2 )] . If a dose is missed, administer the next dose with the next feeding.
Warnings & Precautions
Fibrosing C olonopathy : 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. ( 2.1 , 5.1 ) I rritation of the O ral M ucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 2.3 , 5.2 ) Hyperuricemia: Reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia. ( 5.3 ) Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. ( 5.4 ) 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. ( 5.5 ) 5.1 Fibrosing Colonopathy Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown. If there is history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 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 . Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should be frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration ( 2.1 )] . 5.2 Irritation of the Oral Mucosa Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: Swallow capsules whole. For patients who cannot swallow the capsules whole, the capsules can be opened, and the contents sprinkled in a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt). Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of CREON to ensure complete swallowing. Visually inspect the mouth of pediatric patients less than 12 months of age and of patients who are unable to swallow intact capsules to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration ( 2.3 )] . 5.3 Hyperuricemia Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage ( 10 )]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with CREON. 5.4 Risk of Viral Transmission CREON is sourced from pancreatic tissue from swine used for food consumption. Although the risk that CREON will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported. 5.5 Hypersensitivity Reactions Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see Adverse Reactions ( 6.2 )] . If symptoms occur, initiate appropriate medical management. Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with CREON. The risks and benefits of continued CREON treatment in patients with severe hypersensitivity reactions should be taken into consideration with the overall clinical needs of the patient.
Contraindications
None. None ( 4 )
Adverse Reactions
The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions ( 5.1 )] Irritation of the Oral Mucosa [see Warnings and Precautions ( 5.2 )] Hyperuricemia [see Warnings and Precautions ( 5.3 )] Risk of Viral Transmission [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients : 7 years and older (≥4%): vomiting, dizziness, cough. 4 months to 6 years (6%): vomiting, irritability, decreased appetite. C hronic pancreatitis or pancreatectomy patient s: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to CREON in 92 patients: 67 patients aged 4 months to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis (Studies 1, 2, and 3) and 25 adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (Study 4) [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 , 14.2 )] . Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis in Adult and Pediatric Patients Adult and Pediatric Patients 7 Years of Age and Older The most common adverse reactions, reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Studies 1 and 2, are shown in Table 1. Table 1: Adverse Reactions* in Clinical Trials of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Studies 1 and 2) Adverse Reaction CREON N = 49 n (%) Placebo N = 47 n (%) Vomiting 3 (6%) 1 (2%) Dizziness 2 (4%) 1 (2%) Cough 2 (4%) 0 (0%) * Reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than placebo-treated patients. In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with CREON. Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving CREON and a macrolide antibiotic. Pediatric Patients 4 Months to 6 Years of Age Adverse reactions reported in 18 CREON-treated pediatric patients aged 4 months to 6 years in Study 3 were vomiting, irritability, and decreased appetite, each occurring in 6% of patients [see Use in Specific Populations ( 8.4 )] . Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy in Adults Adverse reactions reported in at least 1 adult CREON-treated patient (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Study 4 is shown in Table 2. Table 2: Adverse Reactions* in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy (Study 4) Adverse Reaction CREON N = 25 n (%) Placebo N = 29 n (%) Hyperglycemia 2 (8%) 2 (7%) Hypoglycemia 1 (4%) 1 (3%) Abdominal Pain 1 (4%) 1 (3%) Abnormal Feces 1 (4%) 0 (0%) Flatulence 1 (4%) 0 (0%) Frequent Bowel Movements 1 (4%) 0 (0%) Nasopharyngitis 1 (4%) 0 (0%) * Reported in at least 1 CREON-treated patient (greater than or equal to 4%) and at a higher rate than placebo-treated patients. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CREON or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye Disorders blurred vision Gastrointestinal D isorders fibrosing colonopathy and distal intestinal obstruction syndrome abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives, and pruritus Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash
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