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Zenpep

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Zenpep

ZENPEP®
(pancrelipase) Delayed-Release Capsules

Zenpep

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, 20,000, 25,000, and 40,000 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 “APTALIS 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, 20,000 and 25,000 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 “APTALIS 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 “APTALIS 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 “APTALIS 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 “APTALIS 20”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide.

25,000 USP units of lipase; 85,000 USP units of protease; 136,000 USP units of amylase. Capsules have a blue opaque cap and a white opaque body with imprint “APTALIS 25”. The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water.

40,000 USP units of lipase; 136,000 USP units of protease; 218,000 USP units of amylase. Capsules have an orange opaque cap and a white opaque body, printed with “APTALIS40”. The shells contain carnauba wax or talc, carrageenan, FD&C Yellow #6, hypromellose, potassium chloride, titanium oxide, and water.

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.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas.
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight...

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, especially of: gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).

This drug may...

Read All Potential Precautions of Zenpep »

Last reviewed on RxList: 4/4/2014
This monograph has been modified to include the generic and brand name in many instances.

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Zenpep - User Reviews

Zenpep User Reviews

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