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 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 »

Zenpep Consumer (continued)

SIDE EFFECTS: Diarrhea, constipation, abdominal pain/cramps, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Zenpep Patient Information Including Side Effects

Brand Names: Cotazym, Cotazym-S, Creon 10, Creon 20, Creon 5, Dygase, Kutrase, Ku-Zyme, Ku-Zyme HP, Lapase, Lipram, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Panokase, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Viokase 8

Generic Name: pancrelipase (oral) (Pronunciation: pan kre LYE pace)

• What is pancrelipase (Zenpep)?


• What are the possible side effects of pancrelipase?


• What is the most important information I should know about pancrelipase?


• What should I discuss with my healthcare provider before taking pancrelipase?


• How should I take pancrelipase?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking pancrelipase?


• What other drugs will affect pancrelipase?


• Where can I get more information?

What is pancrelipase (Zenpep)?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.

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 effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

It is important to use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

Related Drug Centers

• Pancrecarb


• Ultrase


• Ultrase MT


• Creon


• Zenpep


• Creon 5


• Creon 10


• Creon 20


• Viokase