Pancreaze

Generic name:pancrelipase
Drug class:Digestive enzymes
Approval date: April 12, 2010
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Medically reviewed by Drugs.com. Last updated on Aug 24, 2021.

FDA Approves Pancreaze

The U.S. Food and Drug Administration has approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP).

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products.

Pancreaze Medication Guide

Read this Medication Guide before you start taking Pancreaze and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

Warnings

• Pancreaze may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Call your doctor right away if you have any unusual or severe:
  • stomach area (abdominal) pain
  • bloating
  • trouble passing stool (having bowel movements)
  • nausea, vomiting, or diarrhea

Take Pancreaze exactly as prescribed by your doctor. Do not take more or less Pancreaze than directed by your doctor.

What is Pancreaze?

Pancreaze is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. Pancreaze may help your body use fats, proteins, and sugars from food.

Pancreaze contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

Pancreaze is safe and effective in children when taken as prescribed by your doctor.

Before taking this medicine

Before taking Pancreaze, tell your doctor about all your medical conditions, including if you:

• are allergic to pork (pig) products.
• have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy)
• have gout, kidney disease, or high blood uric acid (hyperuricemia)
• have trouble swallowing capsules
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if Pancreaze will harm your unborn baby.
• are breast-feeding or plan to breast-feed. It is not known if Pancreaze passes into your breast milk. You and your doctor should decide if you will take Pancreaze or breast-feed.

Tell your doctor about all the medi..