For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on small amounts of acidic soft food of pH 4.5 or less (e.g., commercially available preparations of bananas, pears and applesauce).

The ZENPEP -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 ZENPEP eva luated in clinical trials is lipase. ZENPEP is dosed by lipase units.

ZENPEP is available in 4 color coded capsule strengths.
Other active ingredients include protease and amylase. Each ZENPEP capsule strength contains the specified amounts of lipase, protease, and amylase.

Capsules of all strengths have a blue radial print on the capsule body and are colored as follows:

5,000 USP units of lipase; 17,000 USP units of protease; 27,000 USP units of amylase capsules have a white opaque cap and white opaque body, printed with “EURAND 5”
10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP units of amylase capsules have a yellow opaque cap and white opaque body, printed with “EURAND 10”
15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP units of amylase capsules have a red opaque cap and white opaque body, printed with “EURAND 15”
20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP units of amylase capsules have a green opaque cap and white opaque body, printed with “EURAND 20”

4 CONTRAINDICATIONS
None.

5 WARNINGS AND PRECAUTIONS

5.1 Fibrosing Colonopathy
Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6000 lipase units/kg of body weight per meal have been associated with colonic strictures in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see Dosage and Administration (2.1)].

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. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titr