Zenpep contains 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.

Zenpep 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.

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

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

Call your doctor at once if you have symptoms of a rare but serious bowel disorder: severe or unusual stomach pain, vomiting, bloating, diarrhea, or constipation.

Before taking this medicine

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

To make sure Zenpep is safe for you, tell your doctor if you have ever had:

• kidney disease;

• gout;

• diabetes;

• a blockage or scarring in your intestines;

• trouble swallowing pills; or

• lactose intolerance.

It is not known whether Zenpep will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Take Zenpep exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not switch brands of this medicine without your doctor's advice.

Zenpep should be taken with a meal or snack.

Read all patient information, medication guides, and instruction sheets provided to you. Be especially careful to follow all directions about giving this medicine to a child. Ask your doctor or pharmacist if you have any questions.

Do not crush, chew, or break a Zenpep capsule or tablet. Swallow it whole with a full glass of water.

Do not hold the pill in your mouth. Pancrelipase can irritate the inside of your mouth.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing. Do not mix the medicine with infant formula or breast milk.

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

Zenpep is sometimes given with a stomach acid reducer such as Nexium, Prevacid, Prilosec, or Protonix. Follow your doctor's instructions about taking all medicines needed to treat your condition.

Tell your doctor if you have any changes in weight. Pancrelipase doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

Use Zenpep regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor if you have any worsening of a long-term pancreas problem.

Usual Adult Dose of Zenpep for Pancreatic Exocrine Dysfunction:

Initial: lipase 500 units/kg orally per meal.

Maintenance: Lipase 400 to 2500 units/kg orally per meal. Give one-half the usual dose with each snack.

Maximum: Total daily dose should not exceed 10,000 lipase units/kg body weight/day.

Usual Adult Dose of Zenpep for Cystic Fibrosis:

Initial: lipase 500 units/kg orally per meal.

Maintenance: Lipase 400 to 2500 units/kg orally per meal. Give one-half the usual dose with each snack.

Maximum: Total daily dose should not exceed 10,000 lipase units/kg body weight/day.

Usual Adult Dose for Chronic Pancreatitis:

8000 to 36,000 lipase USP orally with each meal.

In patients with pancreatectomy or obstruction of pancreatic ducts, lipase 8000 to 16,000 USP orally taken at 2-hour intervals or as directed by physician.

Usual Pediatric Dose for Pancreatic Exocrine Dysfunction:

Less than 1 year:
2000 to 4000 units per 120 mL of formula, breast milk, or per breast-feeding

Greater than 1 to less than 4 years:
Initial dose: 1000 units/kg/meal
Dosage range: 1000 to 2500 units/kg/meal

Greater than or equal to 4 years:
Refer to adult dosing.

In cystic fibrosis, the powder is given as one-fourth teaspoonful (0.7 g) with meals.

Usual Pediatric Dose for Cystic Fibrosis:

Less than 1 year:
2000 to 4000 units per 120 mL of formula, breast milk, or per breast-feeding

Greater than 1 to less than 4 years:
Initial dose: 1000 units/kg/meal
Dosage range: 1000 to 2500 units/kg/meal

Greater than or equal to 4 years:
Refer to adult dosing.

In cystic fibrosis, the powder is given as one-fourth teaspoonful (0.7 g) with meals.

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

To make sure Zenpep is safe for you, tell your doctor if you have ever had:

• kidney disease;

• gout;

• diabetes;

• a blockage or scarring in your intestines;

• trouble swallowing pills; or

• lactose intolerance.

It is not known whether Zenpep will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Take the missed dose with your next meal or snack. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Call your doctor at once if you have:

• joint pain or swelling; or

• symptoms of a rare but serious bowel disorder - severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation.

Tell your doctor if your child is not growing at a normal rate while using Zenpep.

Common Zenpep side effects may include:

• stomach pain, gas, vomiting;

• diarrhea, frequent or abnormal bowel movements;

• rectal itching;

• headache, dizziness;

• runny or stuffy nose, cough, sore throat; or

• changes in your blood sugar.

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.

Other drugs may interact with pancrelipase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.