nded. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age [see Warnings and Precautions (5.1)]. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.
2.2 Administration
CREON should always be taken as prescribed by a healthcare professional.
Infants (up to 12 months)
CREON should be administered to infants immediately prior to each feeding, using a dosage of 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Contents of the capsule may be administered directly to the mouth or with a small amount of applesauce. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that CREON is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.
Children and Adults
CREON should be taken during meals or snacks, with sufficient fluid. CREON capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.
For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4 or less, such as applesauce, at room temperature. The CREON-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.
3 DOSAGE FORMS AND STRENGTHS
The active ingredient in CREON eva luated in clinical trials is lipase. CREON is dosed by lipase units.
Other active ingredients include protease and amylase. Each CREON capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
•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.
•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.
•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.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
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5.1 Fibrosing Colonopathy
Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products.4, 5 Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most |
