Pancrelipase is a type of pancreatic enzyme commercialized in the form of delayed-release capsules. Due to a lack of pancreatic enzymes, which are the substances responsible for breaking down food during digestion, 87% of patients who suffer from cystic fibrosis need to take enzymes, according to the Cystic Fibrosis Foundation (CFF). Cystic fibrosis affects the pancreas, leading to difficulties in properly digesting food, particularly fats and proteins, as well as to the development of large, greasy, smelly stools.

According to the guidelines of the U.S. Food and Drug Administration (FDA), CreonPancreaze, PertzyeUltresa, Viokace, and Zenpep are the only brands of Pancreatic Enzyme Products (PEP) approved in the US, but other brands like Cotazym, Cotazym-S, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Lipram, Lipram UL, Palcaps 10, Pancrease MT, Pancrecarb MS, Pangestyme CN 10, Pangestyme EC, Panocaps, Panocaps MT 16, and Panokase are also available.

History of Pancrelipase

“As of May 17, 2012, FDA has approved six PEPs because they meet the regulatory standards for quality, safety, and effectiveness. Creon and Zenpep were approved for marketing in 2009, Pancreaze was approved in April 2010, Ultresa and Viokace were approved in March 2012 and Pertzye was approved May 17, 2012.  All approved PEP products have drug labels with important information for healthcare professionals and Medication Guides for patients that explain the product’s risks and benefits,” explains the FDA, which works continuously in collaboration with patient advocacy groups and professional healthcare organizations in order to raise awareness about the six approved products.

How Pancrelipase Works

Pancrelipase is administered orally as part of a personalized therapy usually initiated with lower doses that are gradually increased. Due to cystic fibrosis, the body produces thick, sticky mucus that may clog the pancreas, the lungs, and other parts of the body. However, pancrelipase is able to improve digestion of food by acting as replacement of the enzymes and decreasing fatty bowel movements. The definition of the therapy with pancrelipase is made by a physician, based on patients’ symptoms and clinical condition, and it complements the administration of other medications.

Other Details about Pancrelipase

In addition to adults, children at all ages may also be treated with Pancrelipase or other enzyme products. However, dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal. Potential side effects associated with the treatment with Pancrelipase include headache, cough, sore throat, neck pain, dizziness, nosebleed, feeling full after eating a small amount, heartburn, constipation, gas, irritation around the anus, and sore mouth or tongue.
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