ZENPEP - pancrelipase lipase, pancrelipase protease and pancrelipase amylase capsule, delayed release 
Eurand Pharmaceuticals Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZENPEP safely and effectively. See full prescribing information for ZENPEP.
ZENPEP® (pancrelipase) delayed release capsules
Initial U.S. Approval: 2009
INDICATIONS AND USAGE
ZENPEP® 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 (1)
DOSAGE AND ADMINISTRATION
Dosage
ZENPEP 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. (2.1)
Do not mix ZENPEP 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 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. (2.1)
Children 4 Years and Older and Adults

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal 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. (2.1)
Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines (2.1)
Administration

ZENPEP should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food, e.g., applesauce. (2.2)
 
DOSAGE FORMS AND STRENGTHS
Capsules: 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 body, printed with “EURAND 5” (3)
Capsules: 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” (3)
Capsules: 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” (3)
Capsules: 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”(3)
 
CONTRAINDICATIONS
None (4)
 
WARNINGS AND PRECAUTIONS
Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ZENPEP 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)
To avoid irritation of oral mucosa, do not chew ZENPEP or retain in the mouth. (5.2)
Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia. (5.3)
There is theoretical risk of viral transmission with all pancreatic enzyme products including ZENPEP. (5.4)
Exercise caution when administer