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,
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 bicarbonatebuffered enteric-coated microspheres ranging in size from
0.8 – 2.2 mm in diameter.
The active ingredient evaluated in clinical trials is
lipase. PERTZYE is dosed by lipase units. Other active ingredients include
protease and amylase.
Inactive ingredients in PERTYZE include sodium bicarbonate,
sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl
phthalate, ursodiol, polyvinylpyrrolidone, and talc and are contained in hard
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
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: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.