Pancreaze

(pancrelipase) Microtablets

DRUG DESCRIPTION

PANCREAZE 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.

Each capsule for oral administration contains enteric-coated microtablets that are each approximately 2 mm in diameter.

The active ingredient evaluated in clinical trials is lipase. PANCREAZE is dosed by lipase units. Other active ingredients include protease and amylase.

Inactive ingredients in PANCREAZE include cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

PANCREAZE is available in four color coded strengths. Each PANCREAZE capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

4,200 USP units of lipase; 10,000 USP units of protease; 17,500 USP units of amylase. The hard gelatin capsules have a yellow opaque body and clear cap imprinted with “McNEIL” and “MT 4”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.

10,500 USP units of lipase; 25,000 USP units of protease; 43,750 USP units of amylase. The hard gelatin capsules have a pink opaque body and clear cap imprinted with “McNEIL” and “MT 10”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.

16,800 USP units of lipase; 40,000 USP units of protease; 70,000 USP units of amylase. The hard gelatin capsules have a salmon opaque body and clear cap imprinted with “McNEIL” and “MT 16”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.

21,000 USP units of lipase; 37,000 USP units of protease; 61,000 USP units of amylase. The hard gelatin capsules have a white opaque body and cap imprinted with “McNEIL” and “MT 20”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, and gelatin capsule imprint ink.

Last reviewed on RxList: 6/9/2014
This monograph has been modified to include the generic and brand name in many instances.

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