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Pronunciation
(pan kre LYE pase)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes powder
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Replacement therapy in symptomatic treatment of malabsorption syndrome caused by pancreatic insufficiency
Use: Unlabeled/Investigational
Treatment of occluded feeding tubes
Pregnancy Risk Factor
B/C (product specific)
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
Systemic absorption and concentration in the breast milk is unlikely, but unknown.
Contraindications
Hypersensitivity to pork protein or any component of the formulation; acute pancreatitis or acute exacerbations of chronic pancreatic disease
Warnings/Precautions
Concerns related to adverse effects:
• Fibrotic strictures: In the colon, fibrotic strictures (some requiring surgery) have been reported with high doses; use caution, especially in children with cystic fibrosis.
Dosage form specific issues:
• Brand interchangeability: Use caution when adjusting doses or changing brands.
• Capsules: Pancrelipase is inactivated by acids; do not crush or chew, some capsules may be opened and sprinkled on food.
• Powder: Avoid inhalation of powder; may cause nasal and respiratory tract irritation.
Adverse Reactions
Frequency not defined; occurrence of events may be dose related.
Central nervous system: Pain
Dermatologic: Rash
Endocrine & metabolic: Hyperuricemia
Gastrointestinal: Nausea, cramps, constipation, diarrhea, perianal irritation/inflammation (large doses), irritation of the mouth, abdominal pain, intestinal obstruction, vomiting, flatulence, melena, weight loss, fibrotic strictures, greasy stools
Ocular: Lacrimation
Renal: Hyperuricosuria
Respiratory: Sneezing, dyspnea, bronchospasm
Miscellaneous: Allergic reactions
Drug Interactions
There are no known significant interactions.
Ethanol/Nutrition/Herb Interactions
Food: Avoid placing contents of opened capsules on alkaline food (pH >5.5); pancrelipase may impair absorption of oral iron and folic acid.
Storage
Store between 15°C to 25°C (59°F to 77°F); do not refrigerate. Keep in a dry place.
Mechanism of Action
Pancrelipase is a natural product harvested from the hog pancreas. It contains a combination of lipase, amylase, and protease. Products are formulated to dissolve in the more basic pH of the duodenum so that they may act locally to break down fats, protein, and starch.
Pharmacodynamics/Kinetics
Absorption: None; acts locally in GI tract
Excretion: Feces
Dosage
Oral:
Powder: Actual dose depends on the condition being treated and the digestive requirements of the patient
Children <1 year: Start with 1/8 teaspoonful with feedings
Adults: 0.7 g (1/4 teaspoonful) with meals
Capsules/tablets: The following dosage recommendations are only an approximation for initial dosages. The actual dosage will depend on the condition being treated and the digestive requirements of the individual patient. Adjust dose based on body weight and stool fat content. Total daily dose reflects ?3 meals/day and 2-3 snacks/day, with half the mealtime dose given with a snack. Older patients may need less units/kg due to increased weight, but decreased ingestion of fat/kg. Maximum dose: 2500 units of lipase/kg/meal (10,000 units of lipase/kg/day)
Children:
<1 year: 2000 units of lipase with meals
1-6 years: 4000-8000 units of lipase with meals and 4000 units with snacks
7-12 years: 4000-12,000 units of lipase with meals and snacks
Adults: 4000-48,000 units of lipase with meals and with snacks
Occluded feeding tubes: One tablet of Viokase® crushed with one 325 mg tablet of sodium bicarbonate (to activate the Viokase®) in 5 mL of water can be instilled into the nasogastric tube and clamped for 5 minutes; then, flushed with 50 mL of tap water
Administration: Oral
Oral: Administer with meals or snacks and swallow whole with a generous amount of liquid. Do not crush or chew; retention in the mouth before swallowing may cause mucosal irritation and stomatitis. Delayed-release capsules containing enteric-coated microspheres or microtablets may also be opened and the contents sprinkled on soft food with a low pH that does not require chewing, such as applesauce, gelatin; apricot, banana, or sweet potato baby food; baby formula. Dairy products such as milk, custard, or ice cream may have a high pH and should be avoided. Avoid inhalation of powder, may cause nasal and respiratory tract irritation.
Monitoring Parameters
Abdominal symptoms, nutritional intake, growth (in children), stool character, fecal fat
Dietary Considerations
Should be used as part of a high-calorie diet, appropriate for age and clinical status. Administer with meals or snacks and swallow whole with a generous amount of liquid. Do not crush or chew. Delayed-release capsules containing enteric coated microspheres or microtablets may also be opened and the contents sprinkled on soft food with a low pH such as applesauce, gelatin; apricot, banana, or sweet potato baby food; baby formula. Dairy products such as milk, custard or ice cream may have a high pH and should be avoided.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. Take right before or with foods and swallow whole with a generous amount of liquid. Dairy products, such as milk, custard, or ice cream, may have a high pH and should not taken together with this medication. Do not crush or chew tablets or regular capsules. Delayed-release capsules containing enteric coated microspheres or microtablets may be opened and the contents sprinkled on soft food with a low pH such as applesauce, gelatin, apricot, banana, or sweet potato baby food. Powder: If powder spills on skin, wash off immediately, do not inhale powder when preparing. You may experience some gastric discomfort. Report unusual rash, persistent GI upset; or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Geriatric Considerations
No special considerations are necessary since drug is dosed to response; however, drug-induced diarrhea can result in unwanted side effects (eg, confusion, hypotension, lethargy, fluid and electrolyte loss).
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Dosing and administration depends on purpose for use. Use caution preparing powder. If powder spills on skin, wash off immediately. Do not inhale powder. Teach patient possible side effects/appropriate interventions and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule:
ku-zyme® HP: Lipase 8000 units, protease 30,000 units, and amylase 30,000 units [DSC]
Capsule, delayed release, enteric coated granules:
Pangestyme™ CN-10: Lipase 10,000 units, protease 37,500 units, amylase 33,200 units
Pangestyme™ CN-20: Lipase 20,000 units, protease 75,000 units, amylase 66,400 units
Pangestyme™ EC: Lipase 4500 units, protease 25,000 units, and amylase 20,000 units
Pangestyme™ MT16: Lipase 16,000 units, protease 48,000 units, and amylase 48,000 units
Pangestyme™ UL 12: Lipase 12,000 units, protease 39,000 units, and amylase 39,000 units
Pangestyme™ UL 18: Lipase 18,000 units, protease 58,500 units, and amylase 58,500 units
Pangestyme™ UL 20: Lipase 20,000 units, protease 65,000 units, and amylase 65,000 units
Capsule, delayed release, enteric coated microspheres: Lipase 4500 units, protease 25,000 units, and amylase 20,000 units
Creon® 5: Lipase 5000 units, protease 18,750 units, and amylase 16,600 units
Creon® 10, Palcaps 10: Lipase 10,000 units, protease 37,500 units, and amylase 33,200 units
Creon® 20, Palcaps 20: Lipase 20,000 units, protease 75,000 units, and amylase 66,400 units
Lipram 4500, Panocaps: Lipase 4500 units, protease 25,000 units, and amylase 20,000 units [DSC]
Lipram-CR10: Lipase 10,000 units, protease 37,500 units, and amylase 33,200 units [DSC]
Lipram-CR20: Lipase 20,000 units, protease 75,000 units, and amylase 66,400 units [DSC]
Lipram-PN10: Lipase 10,000 units, protease 30,000 units, and amylase 30,000 units [DSC]
Lipram-PN16, Panocap MT 16: Lipase 16,000 units, protease 48,000 units, and amylase 48,000 units [DSC]
Lipram-PN20, Panocap MT 20: Lipase 20,000 units, protease 44,000 units, and amylase 56,000 units [DSC]
Lipram-UL20, Ultracaps MT 20: Lipase 20,000 units, protease 65,000 units, and amylase 65,000 units [DSC]
Pancrecarb MS-4®: Lipase 4000 units, protease 25,000 units, and amylase 25,000 units [buffered]
Pancrecarb MS-8®: Lipase 8000 units, protease 45,000 units, and amylase 40,000 units [buffered]
Pancrecarb MS-16® Lipase 16,000 units, protease 52,000 units, and amylase 52,000 units [buffered]
Capsule, enteric coated microspheres:
Ultrase®: Lipase 4500 units, protease 25,000 units, and amylase 20,000 units
Capsule, enteric coated microtablets:
Pancrease® MT 4: Lipase 4000 units, protease 12,000 units, and amylase 12,000 units
Pancrease® MT 10: Lipase 10,000 units, protease 30,000 units, and amylase 30,000 units
Pancrease® MT 16: Lipase 16,000 units, protease 48,000 units, and amylase 48,000 units
Pancrease® MT 20: Lipase 20,000 units, protease 44,000 units, and amylase 56,000 units
Capsule, enteric coated minitablets:
Ultrase® MT12: Lipase 12,000 units, protease 39,000 units, and amylase 39,000 units
Ultrase® MT18: Lipase 18,000 units, protease 58,500 units, and amylase 58,500 units
Ultrase® MT20: Lipase 20,000 units, protease 65,000 units, and amylase 65,000 units
Powder (Viokase®): Lipase 16,800 units, protease 70,000 units, and amylase 70,000 units per 0.7 g (227 g)
Tablet: Lipase 8000 units, protease 30,000 units, and amylase 30,000 units
Panokase®: Lipase 8000 units, protease 30,000 units, and amylase 30,000 units [DSC]
Panokase® 16: Lipase 16,000 units, protease 60,000 units, and amylase 60,000 units [DSC]
Plaretase™ 8000: Lipase 8000 units, protease 30,000 units, and amylase 30,000 units
Viokase® 8: Lipase 8000 units, protease 30,000 units, and amylase 30,000 units
Viokase® 16: Lipase 16,000 units, protease 60,000 units, and amylase 60,000 units
Pricing: U.S. (www.drugstore.com)
Capsule, enteric pellets (Creon 10)
33.2-10-37.5 units (100): $120.48
Capsule, enteric pellets (Creon 20)
66.4-20-75 units (100): $229.98
Capsule, enteric pellets (Creon 5)
16.6-5-18.75 units (100): $64.01
Capsule, enteric pellets (Lipram-CR10)
33.2-10-37.5 units (30): $36.23
Capsule, enteric pellets (Lipram-CR20)
66.4-20-75 units (90): $155.93
Capsule, enteric pellets (Lipram-UL12)
39-12-39 units (30): $22.98
Capsule, enteric pellets (Lipram-UL20)
65-20-65 units (100): $124.99
Capsule, enteric pellets (Pancrease)
4500 unit (30): $17.97
Capsule, enteric pellets (Pancrease MT 10)
30-10-30 units (100): $112.22
Capsule, enteric pellets (Pancrease MT 16)
48-16-48 units (30): $53.68
Capsule, enteric pellets (Pancrease MT 20)
56-20-44 units (30): $66.86
Capsule, enteric pellets (Pangestyme CN 20)
66.4-20-75 units (100): $173.53
Capsule, enteric pellets (Pangestyme EC)
4500 unit (100): $43.08
4500 unit (250): $85.33
Capsule, enteric pellets (Pangestyme MT 16)
48-16-48 units (30): $37.01
Capsule, enteric pellets (Ultrase)
4500 unit (100): $61.48
Capsule, enteric pellets (Ultrase MT 12)
39-12-39 units (100): $130.14
Capsule, enteric pellets (Ultrase MT 18)
58.5-18-58.5 units (100): $215.69
Capsule, enteric pellets (Ultrase MT 20)
65-20-65 units (100): $237.39
Capsules (Ku-Zyme HP)
30-8-30 units (100): $76.99
Powder (Viokase)
70-16.8-70 units (227): $238.19
Tablets (Pancrelipase)
30-8-30 units (100): $35.56
Tablets (Panokase)
30-8-30 units (100): $34.50
Tablets (Plaretase 8000)
30-8-30 units (500): $155.65
Tablets (Viokase 16)
60-16-60 units (30): $45.79
Tablets (Viokase 8)
30-8-30 units (100): $72.12
References
FitzSimmons SC, Burkhart GA, Borowitz D, et al, “High-Dose Pancreatic-Enzyme Supplements and Fibrosing Colonopathy in Children With Cystic Fibrosis,” N Engl J Med, 1997, 336(18):1283-9.
Pettei MJ, Leonidas JC, Levinne JJ, et al, “Pancolonic Disease in Cystic Fibrosis and High-Dose Pancreatic Enzyme Therapy,” J Pediatr, 1994, 125(4):587-9.
Taylor CG, “Colonic Strictures in Cystic Fibrosis,” Lancet, 1994, 343(8898):615-6.
International Brand Names
Lexi-Comp.com
Last full review/revision September 2008
Content last modified September 2008
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