digestive enzymes

Digestive enzymes are natural substances produced by thedigestive systemto help digest food. Digestive enzymes are produced in the pancreas, stomach andintestines. Pancreas produces the enzymes lipase, protease and amylase that break downfats, 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(aninheriteddisorder that damages cells that producemucus, sweat and digestive enzymes)
  • Chronic pancreatitis(inflammation of the pancreas)
  • Pancreatectomy (removal of all or part of the pancreas)
  • Pancreatic cancer

• Do not take digestive enzymes if you:
  • Are hypersensitive to the product or any of its components
  • Haveacute pancreatitisor acute exacerbation of chronicpancreatitis
• Use with caution in patients with a history ofgout, 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.

Common side effects of digestive enzymes include:

• Headache
• Neck pain
• Dizziness
• Abdominal cramping
• nauticasea
• Diarrhea
• Gas(flatulence)
• Indigestion
• Abnormal stools
• Gastritis
• Nasalcongestion
• Swelling of extremities (peripheraledema)
• Rash
• Diabetesmellitus exacerbation
• Low blood sugar(hypoglycemia)
• High blood sugar(hyperglycemia)
• Biliary tract stones
• Fluid in the gallbladder (hydrocholecystis)
• Kidneycyst
• 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.

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

慢性胰腺炎或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

• 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.

Inform your doctor of all medications you are currently taking, who can advise you on any possibledrug 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 otherdrugs.

Serious interactions of digestive enzymes include:

• miglitol

Mild interactions of digestive enzymes include:

• acarbose

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 andover-the-countermedications 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.

• Digestive enzymes may be used with caution inpregnancyif potential benefits outweigh risks
• It is not known of digestive enzymes are excreted in milk; use with caution

• 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.