Pancreatin and pancrelipase, both pancreatic enzyme substitutes, are a combination of substances used to replace pancreatic enzymes in people with cystic fibrosis (CF) and conditions like chronic pancreatitis. They are usually commercialized in the form of delayed-release capsules and are often a necessary treatment for cystic fibrosis patients, as the sticky mucus produced in the disease can affect the pancreas, causing problems in properly digesting food, particularly carbohydrates, fats and proteins, and in maintaining a healthy weight.
The U.S. Food and Drug Administration (FDA) began regulating pancreatic enzyme products (PEPs) — like pancreatin or pancrelipase, their generic names — in 1991 because of concern over the widely varying mixes of the three therapeutic enzymes (lipase, amylase, and protease) contained in them. Today, the FDA has approved six PEPs (out of 30 available in the U.S.), under their brand names: Creon and Zenpep (approved in 2009), Pancreaze (2010), and Ultresa, Viokace and Pertzye (2012). But some experts disapprove of the FDA action, criticizing it as too restrictive and for driving up prices. In the U.K., the most common of these products are Creon, Nutrizym, Pancrease HL, and Pancrex, according to Pancreatic Cancer Action.
According to the Cystic Fibrosis Foundation (CFF), 87 percent of CF patients need to take enzyme replacementss because their intestines lack the enzymes necessary to break down food and absorb its nutrients. Food that is not properly digested remains in the intestines, causing gas to build and other problems.
History of Pancreatin/Pancreatic Enzyme Substitutes
Pancreatin, and all pancreatic enzyme substitutes, are a combination of enzymes (amylase, lipase and protease) derived from the pancreas of pigs or cows. Both humans and animals have pancreas that normally produce these enzymes and researchers have studied the use of these chemicals to improve digestion. Pancreatin/pancrelipase is indicated for people with digestive problems due to cystic fibrosis or other conditions affecting the pancreas, as well as for patients who have had their pancreas removed.
How These Drugs Work
Pancreatin and all pancreatic enzyme substitutes do not treat cystic fibrosis symptoms, but are intended to reduce the burden of digestive problems associated with the disease. Thick mucus can affect the pancreas just as it affects the lungs of CF patients, blocking the release of enzymes into the intestines. The drugs — which must be taken with all meals and snacks — work to ease greasy bowel movements and to improve nutrition by breaking down fats, proteins, and starches from food into smaller substances, so they can be absorbed from the intestine.
Patients are usually recommended to start the enzyme therapy with lower doses and, under supervision, gradually increase the dose.
Other Details about Pancreatin
Pancreatin/pancrelipase is known to be a safe therapy, and to be combined with other medication. However, it may cause side effects such as nausea, vomiting, diarrhea, mouth and skin irritation, and allergic reactions. In cases of high dosages, side effects can also include high blood levels of uric acid. Women who are or plan to become pregnant, and women who are breast-feeding, need to be particularly careful, and all CF patients should consult their physician before starting or continuing a pancreatic enzyme replacement treatment.
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