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(pancrelipase) Delayed-Release Capsule
PERTZYE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.
Each PERTZYE delayed-release capsule for oral administration contains bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 - 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 - 2.2 mm in diameter for 8,000 and 16,000 USP units of lipase.
Inactive ingredients in PERTZYE include sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc and are contained in hard gelatin capsules.
4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase. Delayed-Release Capsules have a clear body printed in green with “4” and a clear cap printed with a green circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase. Delayed-Release Capsules have a clear body printed in blue with “8” and a clear cap printed with a blue circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase. Delayed-Release Capsules have a clear body printed in red with “16” and a clear cap printed with a red circular stripe and “DCI”. The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.
Last reviewed on RxList: 10/27/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Pertzye Information
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