Pancrelipase

What is pancrelipase?

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 purposes other than those listed in this medication guide.

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 are allergic to any drugs, or 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 change brands of pancrelipase without first talking to your doctor or pharmacist. Some brands of pancrelipase are interchangeable while others are not. Ask your pharmacist which brands or generic forms can be substituted for another.

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.

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

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

Before taking pancrelipase, tell your doctor if you are allergic to any drugs, or if you have:

• a sudden onset of pancreatitis; or

• worsening of chronic pancreatic disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

How should I take pancrelipase?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not change brands of pancrelipase without first talking to your doctor or pharmacist. Some brands of pancrelipase are interchangeable while others are not. Ask your pharmacist which brands or generic forms can be substituted for another.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using pancrelipase.

Pancrelipase side effects

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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Pancrelipase Dosing Information

Usual Adult Dose 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.

Usual Adult Dose 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.

Usual Adult Dose for Chronic Pancreatitis:

8000 to 32,000 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:

6 months to <1 year: lipase 2000 units per meal.

1 to 6 years: lipase 4000 to 8000 units with each meal and 4000 units with snacks.

7 to 12 years: lipase 4000 to 12,000 units (more if necessary) with each meal and with snacks.

>12 years: lipase 4000 to 20,000 units (more if necessary) with each meal and with snacks.

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

Usual Pediatric Dose for Cystic Fibrosis:

6 months to <1 year: lipase 2000 units per meal.

1 to 6 years: lipase 4000 to 8000 units with each meal and 4000 units with snacks.

7 to 12 years: lipase 4000 to 12,000 units (more if necessary) with each meal and with snacks.

>12 years: lipase 4000 to 20,000 units (more if necessary) with each meal and with snacks.

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

What other drugs will affect pancrelipase?

This list is not complete and there may be other drugs that can interact with pancrelipase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.