Digestive Enzymes

Digestive enzymes are natural substances needed by the body to help break down and digest food. It is used when the pancreas cannot make or does not release enough digestive enzymes into the gut to digest the food. Depending on the amount of enzymes in your product, it may be used for indigestion, as a supplement, or as replacement therapy (in chronic pancreatitis, cystic fibrosis, cancer of the pancreas, after surgery on the pancreas or gut).

• Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.
• The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
• Digestive enzymes is available under the following different brand names: Arco Lase, Digepepsin, and Gustase.

Dosages of Digestive Enzymes:

Adult and Pediatric Dosages

Delayed-release capsules

• Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (8,000 units), protease (28,750 units), amylase (30,250 units)
• Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (16,000 units), protease (57,500 units), amylase (60,500 units)
• Pancrelipase (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
• Zenpep (enteric coated beads): Lipase (3,000 units), protease (10,000 units), amylase (16,000 units)
• Zenpep (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
• Zenpep (enteric coated beads): Lipase (10,000 units), protease (34,000 units), amylase (55,000 units)
• Zenpep (enteric coated beads): Lipase (15,000 units), protease (51,000 units), amylase (82,000 units)
• Zenpep (enteric coated beads): Lipase (20,000 units), protease (68,000 units), amylase (109,000 units)
• Zenpep (enteric coated beads): Lipase (25,000 units), protease (85,000 units), amylase (136,000 units)
• Creon (enteric coated microspheres): Lipase (3,000 units), protease (9,500 units), amylase (15,000 units)
• Creon (enteric coated microspheres): Lipase (6,000 units), protease (19,000 units), amylase (30,000 units)
• Creon (enteric coated microspheres): Lipase (12,000 units), protease (38,000 units), amylase (60,000 units)
• Creon (enteric coated microspheres): Lipase (24,000 units), protease (76,000 units), amylase (120,000 units)

Delayed release capsules, enteric coated microtablets

• Pancreaze: Lipase (4,200 units), protease (10,000 units), amylase (17,500 units)
• Pancreaze: Lipase (10,500 units), protease (25,000 units), amylase (43,750 units)
• Pancreaze: Lipase (16,800 units), protease (40,000 units), amylase (70,000 units)
• Pancreaze: Lipase (21,000 units), protease (37,000 units), amylase (61,000 units)
• Ultresa: Lipase (13,800 units), protease (27,600 units), amylase (27,600 units)
• Ultresa: Lipase (20,700 units), protease (41,400 units), amylase (41,400 units)
• Ultresa: Lipase (23,000 units), protease (46,000 units), amylase (46,000 units)

Tablet

• Viokace: Lipase (10,440 units), protease (39,150 units), amylase (39,150 units)
• Viokace: Lipase (20,880 units), protease (78,300 units), amylase (78,300 units)

Dosage Considerations – Should be Given as Follows:

Pancreatic Insufficiency

Adults:

• 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

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

Chronic Pancreatitis or Pancreatectomy:

• Creon: 72,000 lipase units per meal while consuming at least 100 g of fat per day

Side effects of digestive enzymes include:

• nausea
• diarrhea
• abdominal cramping
• headache
• neck pain
• nasal congestion
• swelling of the legs and feet
• rash
• dizziness
• low blood sugar (hypoglycemia)
• high blood sugar (hyperglycemia)
• diabetes mellitus exacerbation
• gas (flatulence)
• indigestion
• biliary tract stones
• abnormal feces
• fluid in the gallbladder
• renal cyst
• viral infection
• asthma
• inflammation of the stomach (gastritis)
• muscle spasm

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Digestive enzymes have no known severe interactions with other drugs.

Serious interactions of digestive enzymes include:

• miglitol

Mild interactions of digestive enzymes include:

• acarbose

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains digestive enzymes. Do not take Arco Lase, Digepepsin, or Gustase if you are allergic to digestive enzymes or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to any component
• Acute pancreatitis, acute exacerbation of chronic pancreatitis

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Digestive Enzymes?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Digestive Enzymes?"

Cautions

• The dosage depends on the condition being treated and digestive requirements of patients
• Fibrosing colonopathy advancing to colonic strictures reported
• Administering the contents of the capsules alone or mixing in food may cause irritation of the oral mucosa and or loss of enzyme activity

Pregnancy and Lactation

• Use digestive enzymes during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• Side effects of digestive enzymes during breastfeeding are unknown; use caution