digestive enzymes

Digestive enzymes are natural substances produced by the digestive system to help digest food. They are produced in the pancreas, stomach, and intestines. The pancreas produces lipase, protease, and amylase enzymes that break down fats, proteins, and carbohydrates, respectively, into easily absorbable components.

Digestive enzymes may be used as a supplement in cases of natural deficiency or as replacement therapy for patients who lack digestive enzymes due to pancreas removal or pancreatic conditions affecting enzyme production.

Digestive enzymes are used to treat the following conditions in both adults and children:

• Pancreatic insufficiency due to:

• Cystic fibrosis (an inherited disorder damaging mucus, sweat, and digestive enzymes-producing cells)
• 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 or exacerbated chronic pancreatitis

Side effects of digestive enzymes

Common side effects include:

• Headache
• Neck pain
• Dizziness
• Abdominal cramping
• Nausea
• Diarrhea
• Gas (flatulence)
• Indigestion
• Abnormal stools
• Gastritis
• Nasal congestion
• Swelling of extremities (peripheral edema)
• Rash
• Exacerbation of diabetes mellitus
• 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. Contact your doctor for medical advice about serious side effects or adverse reactions. You can also report side effects or health problems to the FDA at 1-800-FDA-1088.

QUESTION

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 per 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 per 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 per day; or 4,000 lipase units/g of fat ingested per day

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 by decreasing supplemental digestive enzymes, while some may require resection of narrowed colon portions.

Drug interactions

Inform your doctor about all medications you are currently taking. Your doctor can advise on potential drug interactions. Do not start, stop, or change the dosage of any medication without your doctor’s recommendation.

Digestive enzymes have no known severe interactions with other drugs.

Mild interactions with digestive enzymes include:

The above drug interactions are not exhaustive. For more information on drug interactions, visit the RxList Drug Interaction Checker.

Always inform your doctor, pharmacist, or healthcare provider about all prescription and over-the-counter medications you are using, along with their dosages. Keep a list of this information. If you have questions about your medication, consult your doctor or healthcare provider.

Pregnancy and breastfeeding

• Digestive enzymes may be used with caution in pregnancy if the potential benefits outweigh the risks.
• It is unknown if digestive enzymes are excreted in milk; use with caution.

Additional information

• Digestive enzymes are not interchangeable. Only use digestive enzymes that meet FDA standards for safety, efficacy, and product quality.
• Creon, Zenpep, Pancreaze, Ultresa, Viokace, and Pertzye are the only FDA-approved digestive enzymes currently marketed in the United States.

Summary

Digestive enzymes are natural substances that aid in food digestion. They can be taken as a supplement to treat pancreatic insufficiency in adults and children caused by cystic fibrosis, chronic pancreatitis, pancreatectomy, or pancreatic cancer. Common side effects include headache, neck pain, dizziness, abdominal cramping, nausea, diarrhea, gas, indigestion, and abnormal stools. Do not take if you have acute pancreatitis.