Generic Name: digestive enzymes
Brand and Other Names: Creon, Pancreaze, Ultresa, Viokace, Pertyze, Zenpep
Drug Class: Pancreatic/Digestive Enzymes
What are digestive enzymes, and what are they used for?
Digestive enzymes are natural substances produced by the digestive system to help digest food. Digestive enzymes are produced in the pancreas, stomach and intestines. Pancreas produces the enzymes lipase, protease and amylase that break down fats, proteins and carbohydrates, respectively, into their components which can be easily absorbed by the body.
Digestive enzymes may be used as a supplement in natural deficiency, and as replacement therapy in patients who lack digestive enzymes due to pancreas removal or pancreatic conditions that affect enzyme production.
Digestive enzymes are used in adults and children for the following conditions:
- Pancreatic insufficiency due to:
- Cystic fibrosis (an inherited disorder that damages cells that produce mucus, sweat and digestive enzymes)
- Chronic pancreatitis (inflammation of the pancreas)
- Pancreatectomy (removal of all or part of the pancreas)
- Pancreatic cancer
Warnings
- Do not take digestive enzymes if you:
- Are hypersensitive to the product or any of its components
- Have acute pancreatitis or acute exacerbation of chronic pancreatitis
- Use with caution in patients with a history of gout, high uric acid levels in blood (hyperuricemia) or impaired kidney function. High doses of digestive enzymes are associated with excessive uric acid in the urine (hyperuricosuria) and hyperuricemia
- Swallow the capsule whole. Administering the contents of the capsules alone or mixing in food may cause irritation in the mouth and/or loss of enzyme activity.
What are the side effects of digestive enzymes?
Common side effects of digestive enzymes include:
- Headache
- Neck pain
- Dizziness
- Abdominal cramping
- Nausea
- Diarrhea
- Gas (flatulence)
- Indigestion
- Abnormal stools
- Gastritis
- Nasal congestion
- Swelling of extremities (peripheral edema)
- Rash
- Diabetes mellitus exacerbation
- Low blood sugar (hypoglycemia)
- High blood sugar (hyperglycemia)
- Biliary tract stones
- Fluid in the gallbladder (hydrocholecystis)
- Kidney cyst
- Asthma
- Muscle spasm
- Viral infection
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
QUESTION
Pancreatitis is inflammation of an organ in the abdomen called the pancreas. See AnswerWhat are the dosages of digestive enzymes?
Combinations of lipase/protease/amylase in 1000 units (KU)
Capsule, delayed-release (contains enteric-coated microspheres)
Creon
- 6KU/19KU/30KU
- 12KU/38KU/60KU
- 24KU/76KU/120KU
- 36KU/114KU/180KU
Capsule, delayed-release (contains enteric-coated microtablets)
Pancreaze
- 4.2KU/10KU/17.5KU
- 10.5KU/25KU/43.75KU
- 16.8KU/40KU/70KU
- 21KU/37KU/61KU
Capsule, delayed-release (contains enteric-coated minitablets)
Ultresa
- 13.8KU/27.6KU/27.6KU
- 20.7KU/41.4KU/41.4KU
- 23KU/46KU/46KU
Capsule, delayed-release (contains enteric-coated microspheres)
Pertzye
- 8KU/28.75KU/30.25KU
- 16KU/57.5KU/60.5KU
- 24KU/86.25KU/90.75KU
Capsule, delayed-release (contains enteric-coated beads)
Zenpep
- 5KU/17KU/27KU
- 10KU/34KU/55KU
- 15KU/51KU/82KU
- 20KU/68KU/109KU
- 25KU/85KU/136KU
Tablet
Viokace
- 10.44KU/39.15KU/39.15KU
- 20.88KU/78.3KU/78.3KU
Adult
Pancreatic Insufficiency
- 500 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose is given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day
- Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day
Chronic Pancreatitis or Pancreatectomy
- Creon: 72,000 lipase units per meal while consuming at least 100 g of fat per day
Pediatric
Pancreatic Insufficiency
Children older than 12 months but younger than 4 years:
- 1,000 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose is given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day
- Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day
Children older than 4 years:
- 500 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose is given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day
- Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day
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Overdose
- Dosage depends on the condition and digestive requirements of the patient.
- Chronic high doses of digestive enzyme products may cause fibrosing colonopathy, a condition that thickens the colon walls, narrowing the colon passage.
- Many patients show improvement with decrease in supplemental digestive enzymes, but some may need resection of the narrowed portions of the colon.
What drugs interact with digestive enzymes?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
Digestive enzymes have no known severe interactions with other drugs.
Serious interactions of digestive enzymes include:
Mild interactions of digestive enzymes include:
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- Digestive enzymes may be used with caution in pregnancy if potential benefits outweigh risks
- It is not known of digestive enzymes are excreted in milk; use with caution
What else should I know about digestive enzymes?
- Digestive enzymes are not interchangeable. It is advisable to use only digestive enzymes that meet the FDA standards for safety, efficacy and product quality.
- Creon, Zenpep, Pancreaze, Ultresa, Viokace, and Pertzye are currently the only FDA-approved digestive enzymes that are marketed in the United States.
Summary
Digestive enzymes are natural substances that help the digestive system break down food. Taken as a supplement, digestive enzymes may be used to treat adults and children with pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis (inflammation of the pancreas), pancreatectomy (removal of all or part of the pancreas), or pancreatic cancer. Common side effects of digestive enzymes include headache, neck pain, dizziness, abdominal cramping, nausea, diarrhea, gas (flatulence), indigestion, abnormal stools, and others. Do not take if you have acute pancreatitis.
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Medications & Supplements
Prevention & Wellness
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https://reference.medscape.com/drug/arco-lase-digepepsin-digestive-enzymes-342066
https://reference.medscape.com/drug/creon-pancreaze-pancrelipase-342069#0
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/updated-questions-and-answers-healthcare-professionals-and-public-use-approved-pancreatic-enzyme
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf