Digestive Enzymes (Oral)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

What are oral digestive enzymes?

Oral digestive enzymes are complex proteins naturally produced by the body to help digest and breakdown the foods we eat. The pancreas is the organ responsible for making and secreting digestive enzymes. Oral digestive enzymes are used when the pancreas is unable to produce enough digestive enzymes.

The main digestive enzymes are

  1. proteases for digesting proteins,
  2. lipases for digesting fats, and
  3. amylases for digesting carbohydrates.

These digestive enzymes are available in pancreatic enzyme products (PEPs).

What diseases and conditions are treated with oral digestive enzymes (PEPs)?

PEPs are used in people with pancreatic diseases such as

Additionally, PEPs may be used in gastrointestinal disorders such as

Quick GuideDigestive Disorders: Common Misconceptions

Digestive Disorders: Common Misconceptions

Are oral digestive enzymes available by prescription and over-the-counter (OTC)?

Digestive enzymes are available over-the-counter (OTC) or by prescription.

  • OTC products are not approved by the FDA and should not be used with the intent to cure or treat any aliments.
  • OTC digestive enzymes are mainly used as a dietary supplements to help with digestion.
  • OTC dietary supplements are not regulated by the FDA and may contain impurities and varying quantities of active ingredients.

A person should speak to their doctor or pharmacist if he/she is interested in starting an OTC regimen.

Prescription digestive enzymes come in various formulations and may contain different amounts of individual digestive enzymes. Therefore, prescription digestive enzymes are not clinically interchangeable and are not considered bioequivalent by the FDA.

What are examples of prescription oral digestive enzymes available in the US?

  • Pancreatin (Ku-Zyme, Kutrase, Lapase)
  • Pancrelipase (Cotazym S, Creon
  • Creon (Lipase 24,000 unit)
  • Creon (Lipase 3,000 unit)
  • Creon (Lipase 12,000 unit)
  • Creon (Lipase 6,000 unit)
  • Creon 10
  • Creon 20
  • Creon 5
  • Dygase
  • Ku-Zyme HP
  • Lipram
  • Lipram 10,000
  • Palcaps-10
  • Palcaps-20
  • Pancrease
  • Pancrease MT 10
  • Pancrease MT 16
  • Pancrease MT 20
  • Pancrease MT 4
  • Pancreaze
  • Pancrecarb MS-16
  • Pancrecarb MS-4
  • Pancrecarb MS-8
  • Pancron 10
  • Pancron 20
  • Pangestyme CN 10
  • Pangestyme CN 20
  • Pangestyme EC
  • Pangestyme MT16
  • Pangestyme UL12
  • Pangestyme UL18
  • Pangestyme UL20
  • Panocaps
  • Panocaps MT-16
  • Panocaps MT-20
  • Panokase
  • Panokase 16
  • PERTZYME
  • Plaretase
  • Ultracaps MT-20
  • Ultrase
  • Ultrase MT 12
  • Ultrase MT 18
  • Ultrase MT20
  • Ultresa
  • Viokace
  • Viokase
  • Zenpep,
  • Zenpep (Lipase 10,000 unit)
  • Zenpep (Lipase 15,000 unit)
  • Zenpep (Lipase 20,000 unit)
  • Zenpep (Lipase 25,000 unit)
  • Zenpep (Lipase 3,000 unit)
  • Zenpep (Lipase 5,000 unit)

What are the side effects of oral digestive enzymes?

Although rare, some patients can experience life-threatening allergic reactions when taking this medicine. Patients should stop their medication immediately and seek emergency medical help if they have any of the following signs or symptoms.

  • Difficulty breathing or talking
  • Swelling of the mouth, face, lips, tongue, or throat
  • Chest tightness
  • Rash or hives
  • Itching
  • Red, swollen, blistered, or peeling skin
  • Wheezing

Other side effects of digestive enzymes include:

This medication can increase the risk of developing a rare but serious bowel problem called fibrosing colonopathy in which there is localized inflammation and scarring in the colon. Patients are advised to call their doctor right away if they have very bad

Many digestive enzymes are derived from pork and therefore, should not be used by patients who are allergic to pork.

What drugs interact with oral digestive enzymes?

The effectiveness of oral digestive enzymes may decrease when they are given with calcium or magnesium containing antacids.

Digestive enzymes containing amylase or other carbohydrate digesting enzymes may reduce the effectiveness of alpha-glucosidase inhibitors (for example, acarbose (Precose), miglitol [Glyset]), a class of oral anti-diabetes medications that are used to reduce the activity of the carbohydrate digesting enzymes.

What formulations of oral digestive enzymes are available?

  • Oral, delayed release capsules are enteric coated to help prevent the capsules from breaking down in the stomach. Enteric coating delays the release of the enzymes until it reaches the lower gastrointestinal tract where its activity is desired.
  • Oral capsules are non-enteric coated capsules and must be taken with a proton pump inhibitor (PPI), a medicine that lowers stomach acidity that can destroy the enzymes.
  • Digestive enzymes are also available as oral mini-microsphere delayed-release capsules, tablet, and powder.

Are taking oral digestive enzymes during pregnancy or while breastfeeding safe?

Oral digestive enzymes have not been adequately studied in pregnant women. Oral digestive enzymes should only be used during pregnancy if the potential benefits to the mother outweigh the potential risks to the unborn baby.

It is not known whether oral digestive enzymes are excreted into breast milk. Pancreatic enzymes mostly act locally in the gastrointestinal tract and are generally not absorbed into the blood stream to make its way to the fetus.

REFERENCES:

FDA Prescribing Information.

Clinical Pharmacology

National Institues of Health. "Dietary Supplement Label Database."
<http://www.dsld.nlm.nih.gov/dsld/>

Summary

Oral digestive enzymes are found in the digestive tract, are naturally produced by the body, and help breakdown the foods we eat. The pancreas makes and secretes digestive enzymes. Prescription and OTC digestive enzymes are available in PEPs or pancreatic enzyme products. PEPs are prescribed for people with cystic fibrosis, chronic pancreatitis, pancreatic cancer or tumors, Shwachman-Diamond syndrome, or removal of part or all of the pancreas. Side effects, drug interactions, dosing, storage, and pregnancy and breastfeeding information should be reviewed prior to taking any medication.

Treatment & Diagnosis

Prevention & Wellness

Quick GuideDigestive Disorders: Common Misconceptions

Digestive Disorders: Common Misconceptions

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Reviewed on 9/24/2015
References
REFERENCES:

FDA Prescribing Information.

Clinical Pharmacology

National Institues of Health. "Dietary Supplement Label Database."
<http://www.dsld.nlm.nih.gov/dsld/>

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