Medication Guide App

Pancrelipase

Pronunciation

Class: Digestants
ATC Class: A09AA
VA Class: GA500
CAS Number: 9001-62-1
Brands: Creon, Ku-Zyme, Lipram, Pancrease, Pancrecarb, Pangestyme, Panokase, Ultrase, Viokase

Warning(s)

REMS:

FDA approved a REMS for pancrelipase to ensure that the benefits outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Enzyme; a digestant principally containing the enzymes amylase, lipase, and protease.100 101 102 103 104

Uses for Pancrelipase

Malabsorption Syndrome

Used as replacement therapy in the symptomatic treatment of malabsorption syndrome caused by established pancreatic insufficiency of organic origin, as in cystic fibrosis of the pancreas, chronic pancreatitis, pancreatectomy, GI bypass surgery (e.g., Billroth II gastroenterostomy), cancer of the pancreas, or other conditions in which pancreatic insufficiency impairs fat digestion.100 101 102 103 104 a

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

May be used as a presumptive test for pancreatic function (e.g., pancreatic insufficiency associated with chronic pancreatitis).103

Pancreatic exocrine replacement therapy should not delay or supplant treatment of the primary disorder.103 a

Has been used in treating steatorrhea of postgastrectomy syndrome and bowel resection; however, pancreatic extracts are less likely to be effective in this condition and in cases of malabsorption associated with ileitis, tuberculosis, or lymphomas.a

Not effective in the treatment of functional digestive disorders unrelated to pancreatic insufficiency.a

Pancrelipase Dosage and Administration

Administration

Oral Administration

Administer orally with meals or snacks.100 101 102

Patients with difficulty swallowing capsules containing enteric-coated spheres, microspheres, or microtablets may open capsules and take the contents with liquids or mix with soft food with a pH <5.5.100 101 102 104 a Follow with a glass of water or juice to ensure swallowing.100 101 102 104

Contact with food having a pH >5.5–6 will dissolve the enteric coating of delayed-release dosage forms.100 101 102 a

Do not chew or crush delayed-release capsules.100 101 102 104 a

Do not inhale powder when it is administered with liquids or mixed with food.a

Patients taking pancreatic enzymes should be adequately hydrated.100 101 102 104

Dosage

Each mg of pancrelipase contains not less than 24 USP units of lipase activity, not less than 100 USP units of amylase activity, and not less than 100 USP units of protease activity.a

On a weight basis, pancrelipase has 12 times the lipolytic activity of pancreatin (no longer commercially available in the US); the trypsin and amylase content of pancrelipase is at least 4 times that of pancreatin.a

Adjust dosage of pancrelipase according to individual requirements (e.g., condition being treated, digestive requirements related to diet).a Considerable dosage variation exists, partly because of the susceptibility of pancrelipase to acid-peptic inactivation of enzyme activity in the stomach and duodenum.a

Delayed-release preparations reportedly are less susceptible to acid-peptic inactivation since they are designed to disintegrate at a relatively high GI pH (e.g., >5.5–6).a

Pediatric Patients

Malabsorption Syndrome

May use growth curves as end points to aid in the assessment of response in children.a

Oral

Children <6 months of age: Dosage not established.a

Children 6 months to <1 year of age: 2000 USP units of lipase activity given with each meal.a

Children 1 to <7 years of age: 4000–8000 USP units of lipase activity with each meal and 4000 USP units of lipase with each snack.a

Children 7–12 years of age: 4000–12,000 USP units of lipase activity with each meal or snack; may increase dosage if needed.a

Delayed-Release Capsules

Children <6 years of age: Dosage based on clinical experience; initially 5000–10,000 USP units of lipase activity given with each meal or snack.100 101 102

Children 6 years of age and older: initially 10,000–20,000 USP units of lipase activity given with each meal or snack.100 101 102

Cystic Fibrosis
Delayed-Release Capsules
Oral

Children <6 years of age: 1500–3000 USP units of lipase activity per kg per meal (units/kg per meal).100 101 102

Adjust dosage according to severity of disease, control of steatorrhea, and nutritional status.100 101 102

Doses >6000 USP units of lipase activity per kg per meal (units/kg per meal) are not recommended.100 101 102

If increased dosage is needed, monitor body weight and stool fat content carefully.100 101 102

Maintain equivalent lipase units for each divided dosage when changing strength of pancrelipase preparations.100 101 102

Adults

Malabsorption Syndrome
Oral

Initially: approximately 4000–33,000 USP units of lipase activity before or with each meal or snack.a 100 101 102 103 104 May increase dosage as necessary and then reduce as symptomatic improvement occurs.a

For severe deficiency: may increase dosage up to 88,000 USP units of lipase activity with each meal or give more frequently (e.g., hourly if necessary and if nausea, cramping, and/or diarrhea does not occur).a

May determine dosage by the fat content of the diet and may give approximately 8000 USP units of lipase activity for each 17 g of dietary fat.a

Prescribing Limits

Pediatric Patients

Cystic Fibrosis
Children <6 years of age
Oral

Maximum 6000 USP units of lipase activity per kg per meal (units/kg/per meal).100 101 102

Special Populations

Geriatric Patients

Select dosage with caution, usually initiating therapy at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.104

Cautions for Pancrelipase

Contraindications

Warnings/Precautions

Warnings

Intestinal Complications

Risk of strictures in the ileocecal region and/or ascending colon in patients with cystic fibrosis receiving high doses of high-potency pancreatic enzyme supplements (containing 20,000 USP units of lipase per capsule).100 101 102 104

Use caution when dosages >6000 USP units of lipase per kg per meal do not resolve symptoms, especially in patients with a history of intestinal complications (e.g., short bowel syndrome, meconium ileus equivalent, surgery, Crohn’s disease).100 101 102 104

If symptoms suggestive of GI obstruction occur, consider the possibility of intestinal stricture and evaluate pancreatic enzyme therapy.100 101 102 104

Sensitivity Reactions

Hypersensitivity to Pork

Use with extreme caution, if at all, in patients allergic to pork products.a

If hypersensitivity reaction occurs, discontinue pancreatin (no longer commercially available in the US), and institute symptomatic and supportive measures if needed.100 101 102 103 104 a

Other Hypersensitivity Reactions

Avoid inhaling pancrelipase powder (e.g., when capsules are opened) since it is irritating to the nasal mucosa and respiratory tract and may precipitate bronchospasm in patients sensitized to pancreatic enzyme concentrates.103 a

Specific Populations

Pregnancy

Category C.100 101 102 103 104

Lactation

Not known whether pancrelipase is distributed into milk100 101 102 103 104 . Caution advised if pancrelipase is used.100 101 102 103 104

Pediatric Use

Dosage not established in children <6 months of age.a

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.104 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Nausea,100 101 102 103 104 a vomiting,100 101 102 104 bloating, 100 101 102 104 stomach cramps or pain,100 101 102 103 104 a constipation,100 101 102 104 diarrhea,100 101 102 103 104 a and (in high doses) hyperuricosuria and hyperuricemia.103 104 a

Interactions for Pancrelipase

Specific Drugs

Drug

Interaction

Comments

Antacids

Decrease the inactivation of enzyme activitya

Used to therapeutic advantagea

Histamine H2-receptor antagonist (e.g., cimetidine)

Decreases the inactivation of enzyme activitya

Used to therapeutic advantagea

Iron supplements

Pancrelipase decreases serum iron response to oral iron103

Stability

Storage

Oral

Ku-Zyme HP preparations: tight containers ≤25°C.103 a

Pancrease, Pancrease MT, Pancrecarb, Pangestyme delayed-release capsules: tight containers at 15–25°C; do not refrigerate open containers.a 104

Viokase preparations: tight containers at ≤25°C (dry place).a

Creon delayed-release capsules: tight, light-resistant containers at 25°C (may be exposed to 15–30°C); protect from moisture.100 101 102 Do not refrigerate.100 101 102

Actions

  • Catalyzes hydrolysis of fats to glycerol and fatty acids and protein into proteoses and derived substances; converts starch into dextrins and short-chain sugars.100 101 102 103 104

  • Reduces fat and nitrogen content in stool.103

  • If sufficient pancreatic enzymes are delivered to the small intestine, malabsorption could be corrected.103

Advice to Patients

  • Advise patients to take pancrelipase with each meal and snack or as directed by a clinician.100 101 102 104

  • Advise patients not to exceed prescribed dosage range without contacting a clinician.100 101 102 104

  • Do not chew or crush delayed-release capsules.100 101 102 104

  • Swallow delayed-release capsules whole or open capsules and sprinkle contents on soft, bland food.100 101 102 104 Follow with a glass of water or juice to ensure swallowing.100 101 102 104

  • Advise patients to maintain adequate fluid intake.100 101 102 104

  • Advise patients to avoid inhalation of powder if capsules are opened or if administered as powder.103 a Sensitive individuals may experience allergic reactions.103 a

  • Importance of discontinuing the drug and informing clinician if an allergic or hypersensitivity reaction occurs.100 101 102 103 104

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.100 101 102 103 104

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.100 101 102 103 104

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pancrelipase

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

8000 USP units Lipase activity, 30,000 USP units Amylase activity, and 30,000 USP units Protease activity

Ku-Zyme HP

Schwarz

Capsules, delayed-release (containing enteric-coated spheres, microspheres, or microtablets)

4000 USP units Lipase activity, 12,000 USP units Amylase activity, and 12,000 USP units Protease activity

Pancrease MT 4 (enteric-coated microtablets)

Ortho-McNeil

4000 units USP units Lipase activity, with 25,000 USP units Amylase activity, and 25,000 USP units Protease activity

Pancrecarb MS-4 (with enteric-coated microspheres)

Digestive Care

4500 USP units Lipase activity, 20,000 USP units Amylase activity, and 25,000 USP units Protease activity

Lipram 4500 (with povidone; enteric-coated microspheres)

Global

Pancrease (with povidone; enteric-coated microspheres)

Ortho-McNeil

Pangestyme

Ethex

Ultrase (with povidone; enteric-coated microspheres)

Axcan Scandipharm

5000 USP units Lipase activity, with 16,600 USP units Amylase activity, and 18,750 USP units Protease activity

Creon 5 Minimicrospheres (enteric-coated microspheres)

Abbott

Lipram-CR5 (with povidone; enteric-coated microspheres)

Global

8000 USP units Lipase activity, with 40,000 USP units Amylase activity, and 45,000 USP units Protease activity

Pancrecarb MS-8 (with sodium bicarbonate buffer; enteric-coated microspheres)

Digestive Care

10,000 USP units Lipase activity, 30,000 USP units Amylase activity, and 30,000 USP units Protease activity

Lipram-PN10 (with povidone; enteric-coated microspheres)

Global

Pancrease MT 10 (enteric-coated microtablets)

Ortho-McNeil

10,000 USP units Lipase activity, with 33,200 USP units Amylase activity, and 37,500 USP units Protease activity

Creon 10 Minimicrospheres (enteric-coated microspheres)

Abbott

Lipram-CR10 (with povidone; enteric-coated microspheres)

Global

Pangestyme CN 10

Ethex

12,000 USP units Lipase activity, with 39,000 USP units Amylase activity, and 39,000 USP units Protease activity

Lipram-UL12 (with povidone; enteric-coated microspheres)

Global

Pangestyme UL 12

Ethex

Ultrase MT12 (enteric-coated minitablets)

Axcan Scandipharm

16,000 USP units Lipase activity, 48,000 USP units Amylase activity, and 48,000 USP units Protease activity

Lipram-PN16 (with povidone; enteric-coated microspheres)

Global

Pancrease MT 16 (enteric-coated microtablets)

Ortho-McNeil

Pangestyme MT 16

Ethex

16,000 units USP units Lipase activity, with 52,000 USP units Amylase activity, and 52,000 USP units Protease activity

Pancrecarb MS-16 (with enteric-coated microspheres)

Digestive Care

18,000 USP units Lipase activity, with 58,500 USP units Amylase activity, and 58,500 USP units Protease activity

Lipram-UL18 (with povidone; enteric-coated microshperes)

Global

Pangestyme UL 18

Ethex

Ultrase MT18 (enteric-coated minitablets)

Axcan Scandipharm

20,000 USP units Lipase activity, with 56,600 USP units Amylase activity, and 44,000 USP units Protease activity

Lipram-PN20 (with povidone; enteric-coated microspheres)

Global

Pancrease MT 20 (enteric-coated microtablets)

Ortho-McNeil

20,000 USP units Lipase activity, with 65,000 USP units Amylase activity, and 65,000 USP units Protease activity

Lipram-UL20 (with povidone; enteric-coated microspheres)

Global

Pangestyme UL 20

Ethex

Ultrase MT20 (enteric-coated minitablets)

Axcan Scandipharm

20,000 USP units lipase activity, with 66,400 USP units Amylase activity, and 75,000 USP units Protease activity

Creon 20 Minimicrospheres (enteric-coated microspheres)

Abbott

Lipram-CR20 (with povidone; enteric-coated microspheres)

Global

Pangestyme CN 20

Ethex

Powder

16,800 USP units Lipase activity per 0.7 g, 70,000 USP units Amylase activity per 0.7 g, and 70,000 USP units Protease activity per 0.7 g

Viokase

Axcan Scandipharm

Tablets

8000 USP units Lipase activity, 30,000 USP units Amylase activity, and 30,000 USP units Protease activity

Pancrelipase Tablets

Global

Panokase

Breckenridge

Viokase 8

Axcan Scandipharm

16,000 USP units Lipase activity, with 60,000 USP units Amylase activity, and 60,000 USP units Protease activity

Pancrelipase Tablets

Global

Panokase 16

Breckenridge

Viokase 16

Axcan Scandipharm

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Creon 12000UNIT Enteric-coated Capsules (ABBOTT): 30/$61.99 or 90/$166.97

Creon 24000UNIT Enteric-coated Capsules (ABBOTT): 100/$325.00 or 300/$955.97

Creon 6000UNIT Enteric-coated Capsules (ABBOTT): 30/$38.99 or 90/$92.97

Pancreaze 10500Unit Enteric-coated Capsules (JANSSEN): 30/$59.99 or 90/$157.50

Pancreaze 16800Unit Enteric-coated Capsules (JANSSEN): 30/$87.99 or 90/$242.74

Pancreaze 21000Unit Enteric-coated Capsules (JANSSEN): 30/$109.99 or 90/$310.97

Pancreaze 4200Unit Enteric-coated Capsules (JANSSEN): 30/$30.99 or 60/$50.97

Pancrelipase (Lip-Prot-Amyl) 5000UNIT Enteric-coated Capsules (X-GEN PHARMACEUTICALS): 30/$30.99 or 60/$49.97

Ultrase MT 18 58.5-18-58.5MU Enteric-coated Capsules (AXCAN PHARMA US): 100/$260.00 or 300/$770.01

Zenpep 15000UNIT Enteric-coated Capsules (AXCAN PHARMA US): 30/$80.99 or 90/$225.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions November 2, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Solvay Pharmaceuticals. Creon 5 minimicrospheres (pancrelipase delayed-release capsules) prescribing information. Marietta, GA; 2006 Feb.

101. Solvay Pharmaceuticals. Creon 10 minimicrospheres (pancrelipase delayed-release capsules) prescribing information. Marietta, GA; 2006 Feb.

102. Solvay Pharmaceuticals. Creon 20 minimicrospheres (pancrelipase delayed-release capsules) prescribing information. Marietta, GA; 2006 Feb.

103. Schwarz Pharma. ku-zyme HP (lipase, amylase, protease) prescribing information. Milwaukee, WI; 2004 Aug. (www.schwarzusa.com/products.other.htm)

104. Ethex. Pangestyme pancrelipase delayed-release capsules. St Louis, MO; 2002 Jul.

a. AHFS drug information 2007. McEvoy GK, ed. Pancrelipase. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2931-2.

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