Dosing & Uses
Dosage Forms & Strengths
lipase/protease/amylase
(KU=1000 units)
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
tablet
- Viokace
- 10.44KU/39.15KU/39.15KU
- 20.88KU/78.3KU/78.3KU
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
Exocrine Pancreatic Insufficiency
Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions
- Cystic fibrosis guidelines: Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day
- Administer 50% of meal dose with snacks
- High-dose Creon: In 1 clinical trial described in the prescribing information, adults received a dose of 72,000 lipase units/meal while consuming at least 100 g of fat/day for chronic pancreatitis or pancreatectomy; lower starting doses (ie, 500 lipase units/kg/meal) are consistent with Cystic Fibrosis guidelines
Viokace
- Only indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (and not cystic fibrosis)
- Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day
- Administer 50% of meal dose with snacks
- Viokace should be administered with a PPI
Dosing Considerations
For patients who are unable to swallow intact capsules, may carefully open capsules and contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, or administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger (only for the 4,000 USP lipase unit capsule strength); if administered orally, the mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion
Dosage Forms & Strengths
lipase/protease/amylase
(KU=1000 units)
capsule, delayed-release (enteric-coated microspheres)
- Creon
- 3KU/9.5KU/15KU
- 6KU/19KU/30KU
- 12KU/38KU/60KU
- 24KU/76KU/120KU
capsule, delayed-release (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
tablet
- Viokace
- 10.44KU/39.15KU/39.15KU
- 20.88KU/78.3KU/78.3KU
capsule, delayed-release (contains enteric-coated microspheres)
- Pertzye
- 4KU/14.375KU/15.125KU
- 8KU/28.75KU/30.25KU
- 16KU/57.5KU/60.5KU
- 24KU/86.25KU/90.75KU
capsule, delayed-release (contains enteric-coated beads)
- Zenpep
- 3KU/10KU/16KU
- 5KU/17KU/27KU
- 10KU/34KU/55KU
- 15KU/51KU/82KU
- 20KU/68KU/109KU
- 25KU/85KU/136KU
Exocrine Pancreatic Insufficiency
Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions
Creon/Zenpep
- ≤12 months: 3000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Pancreaze
- ≤12 months: 2000-4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- Not to exceed 10,000 unit lipase/kg/day or <4,000 lipase unites/g fat ingested daily
Pertzye
- ≤12 months: 4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-4 years and weight ≥8 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years and weight ≥16 kg: Initiate at 500 lipase units/kg per meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Ultresa
- 1-4 years and weight >14 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years and weight >28 kg: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Viokace
- Safety and effectiveness not established
Recommendations from Cystic Fibrosis Foundation Consensus Report
- Infants <2 years is 2000-5000 lipase units/120 mL feeding; as infant grows, adjust dose not to exceed 2500 lipase units/kg/feeding (or 10,000 lipase units/kg/day)
- In general, daily requirements of 500-4000 lipase units/g of fat are required
- J Pediatr 2009;155(6 Suppl):S73-S93
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (10)
- acarbose
pancrelipase decreases effects of acarbose by pharmacodynamic antagonism. Use Caution/Monitor. Antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes.
- calcium carbonate
calcium carbonate decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.
- ferric maltol
pancrelipase decreases levels of ferric maltol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.
- ferrous fumarate
pancrelipase decreases levels of ferrous fumarate by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.
- ferrous gluconate
pancrelipase decreases levels of ferrous gluconate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.
- ferrous sulfate
pancrelipase decreases levels of ferrous sulfate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.
- folic acid
pancrelipase decreases levels of folic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. folic deficiency may occur.
- magnesium hydroxide
magnesium hydroxide decreases effects of pancrelipase by pharmacodynamic antagonism. Use Caution/Monitor. Antacids may negate beneficial effects of enzymes.
- miglitol
pancrelipase decreases levels of miglitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Digestive enzymes may reduce levels of miglitol when administered concomitantly.
- polysaccharide iron
pancrelipase decreases levels of polysaccharide iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Levels of iron salts may decrease with concomitant administration of digestive enzymes.
Minor (0)
Adverse Effects
>10%
Abdominal pain/cramping (3-18% )
Headache (3-15% )
1-10%
Dyspepsia (10%)
Cough (4-10%)
Diarrhea (0-10%)
Hyperglycemia (8%)
Pharyngolaryngeal pain (7%)
Epistaxis (7%)
Anal pruritus (7%)
Biliary tract stones (7%)
Vomiting (6%)
Contusion (6%)
Weight loss (6%)
Early satiety (6%)
Flatulence (5-6%)
Dizziness (4%)
Hypoglycemia (4%)
Abnormal feces (4%)
Frequent bowel movements (4%)
Nasopharyngitis (4%)
Anemia (3%)
Ascites (3%)
Flatulence (3%)
Peripheral edema (3%)
Hydrocholecystis (3%)
Viral infection (3%)
Renal cyst (3%)
Rash (3%)
Postmarketing Reports
Severe allergic reactions including anaphylaxis, asthma and hives
Skin disorders including pruritus, rash and urticaria
Asymptomatic elevations of liver enzymes
Gastrointestinal disorders: Abdominal distension, abdominal pain, diarrhea, flatulence, constipation and nausea; rare reports of fibrosing colonopathy and distal intestinal obstruction syndrome
Endocrine: May affect glycemic control in susceptible individuals
Warnings
Contraindications
Documented hypersensitivity
Cautions
Avoid exceeding maximum dose due to risk of fibrosing colonopathy; ≥6,000 lipase units/kg per meal associated with colonic stricture, indicative of fibrosing colonopathy, particularly in children ≤12 years
Swallow pills as chewing or retaining in mouth may cause oral mucosa irritation; do not chew, crush or mixed in foods having a pH ≥4.5
Monitor uric acid levels in patients with gout, hyperuricemia or renal impairment due to risk of hyperuricemia
Caution in patients with known allergy or porcine proteins
Do not exceed ≥2,500 units/kg per meal (or ≥10,000 lipase units/kg per day or ≥ 4000 lipase units/g fat ingested per day)
Avoid inhalation of powder
Theoretical risk of viral transmission
Pregnancy & Lactation
Pregnancy Category: C
Lactation: unknown
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Product contains a combination of lipase, protease, and amylase that replace endogenous pancreatic enzymes and catalyze the hydrolysis of starches into dextrins and short chain sugars such as maltose and maltotriose, fats to monoglycerides, glycerol and free fatty acids and proteins into peptides and amino acids in the duodenum and proximal small intestine
Pharmacokinetics
Absorption: not absorbed, acts locally in GI tract
Excretion: feces
Administration
Oral Administration
Pancrelipase products are not interchangeable
Initiate therapy at lowest recommended dose and increase gradually
Individualize therapy based on symptoms, degree of steatorrhea, fat content of diet, and patient response
Children and adults
- Usually, 50% of the full meal dose should be administered with snacks; total daily dosage should reflect approximately 3 meals plus 2-3 snacks per day
- Decrease dose in geriatric patients as, on average, they weigh more but tend to ingest less fat per kilogram of body weight
- Capsule should be swallowed whole with sufficient fluid; do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
- Unable to swallow capsule: Capsule contents may be sprinkled on applesauce, yogurt, or acidic soft food with pH <4.5 and consumed without chewing; follow with water or juice to ensure complete ingestion and to ensure nothing is retained in the mouth to avoid mucosal irritation
Gastrostomy tube administration (Pertzye)
- Contents of one or two 4000-unit lipase capsules can be administered with soft foods via gastrostomy tube (G-tube) with a diameter ≥14 French
- Note: The 4000-unit Pertzye capsules were developed with reduced size microspheres to meet requirements needed to administer via G-tube
- Flush G-tube with 10 mL of water
- Discard any unused portion of pancrelipase-soft food mixture; do not save for later use
- If dose requires >two 4000-unit lipase capsules, repeat process until prescribed dose is reached
Infants aged ≤12 months
- Do not mix capsule contents directly into formula or breast milk (may decrease efficacy)
- Administered to infants immediately prior to each feeding
- Capsule contents may be mixed with ~10 mL of soft acidic food with a pH ≤4.5 (eg, applesauce) or directly to the mouth
- Administration should be followed by breast milk or formula
- Contents of the capsule should not be mixed directly into
- Do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Pertzye oral - | 16,000-57,500- 60,500 unit capsule |  | |
| Pertzye oral - | 16,000-57,500- 60,500 unit capsule |  | |
| Pertzye oral - | 8,000-28,750- 30,250 unit capsule |  | |
| Pertzye oral - | 8,000-28,750- 30,250 unit capsule |  | |
| Viokace oral - | 10,440-39,150- 39,150 unit tablet |  | |
| Viokace oral - | 20,880-78,300- 78,300 unit tablet |  | |
| Pancreaze oral - | 2,600-8,800- 15,200 unit capsule |  | |
| Pancreaze oral - | 16,800-56,800- 98,400 unit capsule |  | |
| Pancreaze oral - | 21,000-54,700- 83,900 unit capsule |  | |
| Pancreaze oral - | 4,200-14,200- 24,600 unit capsule |  | |
| Pancreaze oral - | 10,500-35,500- 61,500 unit capsule |  | |
| Zenpep oral - | 5,000-17,000- 24,000 unit capsule |  | |
| Zenpep oral - | 40,000-126,000- 168,000 unit capsule |  | |
| Zenpep oral - | 3,000-10,000 -14,000-unit capsule |  | |
| Zenpep oral - | 20,000-63,000- 84,000 unit capsule |  | |
| Zenpep oral - | 15,000-47,000 -63,000 unit capsule |  | |
| Zenpep oral - | 10,000-32,000 -42,000 unit capsule |  | |
| Zenpep oral - | 25,000-79,000- 105,000 unit capsule |  | |
| Creon oral - | 24,000-76,000 -120,000 unit capsule |  | |
| Creon oral - | 12,000-38,000 -60,000 unit capsule |  | |
| Creon oral - | 36,000-114,000- 180,000 unit capsule |  | |
| Creon oral - | 6,000-19,000 -30,000 unit capsule |  | |
| Creon oral - | 3,000-9,500- 15,000 unit capsule |  | |
| Bevitrol oral - | 9,000-112,500- 112,500 unit capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
lipase-protease-amylase oral
DIGESTIVE ENZYMES - ORAL
USES: This medication contains digestive enzymes, which 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 (such as 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.
HOW TO USE: Take this medication by mouth with meals and snacks as directed by your doctor.The dosage is based on your medical condition, diet, and response to treatment.If you are using the tablet form of the medication, make sure not to keep it in the mouth because doing so can cause irritation to the gums and cheeks. Swallow the medication with water. For the chewable tablets, chew thoroughly before swallowing.If you are using the capsule form of the medication and swallowing is difficult, the capsule may be opened and the powder mixed with food or liquid.Be careful not to inhale any of the powder because doing so can irritate the inside of the nose or cause an asthma attack.Use this medication regularly to get the most benefit from it.If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.Do not change brands or dosage forms of this product without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Diarrhea, abdominal pain/cramps, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe abdominal discomfort, frequent/painful urination, joint pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this digestive enzyme, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: acarbose, miglitol.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this product with others.
MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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