Zenpep (Pancrelipase Delayed Release Capsules) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

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Zenpep

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ZENPEP®
(pancrelipase)

DRUG DESCRIPTION

ZENPEP 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 cream-colored powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.

Each capsule for oral administration contains enteric-coated beads (1.8-1.9mm for 3,000 and 5,000 USP units of lipase, 2.2-2.5mm for 10,000, 15,000 and 20,000 USP units of lipase).

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

Inactive ingredients in ZENPEP include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate and are contained in hypromellose capsules. The imprinting red ink on the 3,000 capsules strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin.

3,000 USP units of lipase; 10,000 USP units of protease; 16,000 USP units of amylase. Capsules have a white opaque cap and a white opaque body with imprint “EURAND 3”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The imprinting blue ink on the capsules strengths 5,000, 10,000, 15,000 and 20,000 contains dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution.

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 a white opaque body with imprint “EURAND 5”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water.

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 a white opaque body with imprint “EURAND 10”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide.

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 a white opaque body with imprint “EURAND 15”. The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water.

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 a white opaque body with imprint “EURAND 20”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide.

What are the possible side effects of pancrelipase?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

nausea or vomiting;
stomach pain or upset;
diarrhea or constipation;
greasy stools;
rectal irritation; or
bloating or gas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side...

Read All Potential Side Effects and See Pictures of Zenpep »

What are the precautions when taking pancrelipase delayed release capsules (Zenpep)?

Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not...

Read All Potential Precautions of Zenpep »

Last reviewed on RxList: 7/18/2011
This monograph has been modified to include the generic and brand name in many instances.