HIGHLIGHTS OF PRESCRIBING INFORMATION
Indications And Usage
CREON 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 or other conditions.
Dosage And Administration
Dosage (2.1)
CREON is not interchangeable with any other pancrelipase product.
Infants (up to 12 months)
•Infants may be given 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding.
•Do not mix CREON capsule contents directly into formula or breast milk prior to administration. (2.2)
Children Older than 12 Months and Younger than 4 Years
•Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.
Children 4 Years and Older and Adults
•Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.
Limitations on Dosing
•Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.
Administration (2.2)
CREON should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be administered without crushing or chewing, followed by fluid to ensure complete ingestion.
Dosage And Administration 2
•6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1206” and a blue opaque body. (3)
•12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. (3)
•24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1224” and a colorless transparent body. (3)
Contraindications
None.
Warnings And Precautions
•Fibrosing colonopathy, a rare, serious adverse reaction has been described in association with high-dose use of pancreatic enzyme replacement in the treatment of cystic fibrosis patients. Caution should be exercised 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). (5.1)
•Care should be taken to ensure that CREON is not chewed or retained in the mouth to avoid irritation of oral mucosa. (5.2)
•Caution should be exercised when prescribing CREON to patients with gout, renal impairment, or hyperuricemia. (5.3)
•There is theoretical risk of viral transmission with all pancreatic enzyme products including CREON. (5.4)
•Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. (5.5)
Adverse Reactions
•Treatment-emergent adverse events occurring in at least 2 patients (greater than or equal to 6%) receiving CREON or placebo are abdominal pain, abdominal pai