Brand names: Creon, Ku-Zyme, Lipram, Pancrease, Pancrecarb, ... show all 9 brands Pangestyme, Panokase, Ultrase, Viokase
Drug class: Digestants
ATC class: A09AA
VA class: GA500
CAS number: 9001-62-1

Medically reviewed by Drugs.com on Nov 21, 2024. Written by ASHP.

Introduction

Enzyme; a digestant principally containing the enzymes amylase, lipase, and protease.

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.

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

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

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.

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

Pancrelipase Dosage and Administration

Administration

Oral Administration

Administer orally with meals or snacks.

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. Follow with a glass of water or juice to ensure swallowing.

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

Do not chew or crush delayed-release capsules.

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

Patients taking pancreatic enzymes should be adequately hydrated.

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.

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.

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

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).

Pediatric Patients

Malabsorption Syndrome

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

Oral

Children <6 months of age: Dosage not established.

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

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.

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

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.

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

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).

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

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

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

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

Adults

Malabsorption Syndrome

Oral

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

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).

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.

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).

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.

Cautions for Pancrelipase

Contraindications

• Hypersensitivity to pork protein.

• Acute pancreatitis.

• Acute exacerbations of chronic pancreatitis.

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).

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).

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

Sensitivity Reactions

Hypersensitivity to Pork

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

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

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.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether pancrelipase is distributed into milk . Caution advised if pancrelipase is used.

Pediatric Use

Dosage not established in children <6 months of age.

Geriatric Use

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

Common Adverse Effects

Nausea, vomiting, bloating, stomach cramps or pain, constipation, diarrhea, and (in high doses) hyperuricosuria and hyperuricemia.

Drug Interactions

Specific Drugs

Stability

Storage

Oral

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

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

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

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

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.

• Reduces fat and nitrogen content in stool.

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

Advice to Patients

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

• Advise patients not to exceed prescribed dosage range without contacting a clinician.

• Do not chew or crush delayed-release capsules.

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

• Advise patients to maintain adequate fluid intake.

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

• Importance of discontinuing the drug and informing clinician if an allergic or hypersensitivity reaction occurs.

• 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.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

• What are enteric-coated tablets?

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