Pancrelipase

Pronunciation: (pan-KREE-lih-pace)Class: Digestive enzyme

Trade Names:Creon 5- Capsules, delayed-release 5,000 units lipase/18,750 units protease/16,600 units amylase

Trade Names:Creon 10- Capsules, delayed-release 10,000 units lipase/37,500 units protease/33,200 units amylase

Trade Names:Creon 20- Capsules, delayed-release 20,000 units lipase/75,000 units protease/66,400 units amylase

Trade Names:Kutrase- Capsules 2,400 units lipase/30,000 units protease/30,000 units amylase

Trade Names:Lipram-UL12- Capsules, delayed-release 12,000 units lipase/39,000 units protease/39,000 units amylase

Trade Names:Lipram-UL18- Capsules, delayed-release 18,000 units lipase/58,500 units protease/58,500 units amylase

Trade Names:Lipram-UL20- Capsules, delayed-release 20,000 units lipase/65,000 units protease/65,000 units amylase

Trade Names:Pancrease MT 4- Capsules 4,000 units lipase/12,000 units protease/12,000 units amylase

Trade Names:Pancrease MT 10- Capsules 10,000 units lipase/30,000 units protease/30,000 units amylase

Trade Names:Pancrease MT 16- Capsules 16,000 units lipase/48,000 units protease/48,000 units amylase

Trade Names:Pancrease MT 20- Capsules 20,000 units lipase/44,000 units protease/56,000 units amylase

Trade Names:Pancrecarb MS-4- Capsules, delayed-release 4,000 units lipase/25,000 units protease/25,000 units amylase

Trade Names:Pancrecarb MS-8- Capsules, delayed-release 8,000 units lipase/45,000 units protease/40,000 units amylase

Trade Names:Pancrelipase- Capsules 4,500 units lipase/25,000 units protease/20,000 units amylase- Tablets 8,000 units lipase/30,000 units protease/30,000 units amylase- Capsules 16,000 units lipase/48,000 units protease/48,000 units amylase- Tablets 16,000 units lipase/60,000 units protease/60,000 units amylase

Trade Names:Panokase- Tablets 8,000 units lipase/30,000 units protease/30,000 units amylase

Trade Names:Plaretase 8000- Tablets 8,000 units lipase/30,000 units protease/30,000 units amylase

Trade Names:Ultrase- Capsules 4,500 units lipase/25,000 units protease/20,000 units amylase

Trade Names:Ultrase MT 12- Capsules 12,000 units lipase/39,000 units protease/39,000 units amylase

Trade Names:Ultrase MT 18- Capsules 18,000 units lipase/58,500 units protease/58,500 units protease

Trade Names:Ultrase MT 20- Capsules 20,000 units lipase/65,000 units protease/65,000 units protease

Trade Names:Viokase- Powder 16,000 units lipase/60,000 units protease/60,000 units amylase

Trade Names:Viokase 8- Tablets 8,000 units lipase/30,000 units protease/30,000 units amylase

Trade Names:Viokase 16- Tablets 16,000 units lipase/60,000 units protease/60,000 units amylase

Cotazym (Canada)Creon 5 Minimicrospheres (Canada)Creon 10 Minimicrospheres (Canada)Creon 20 Minimicrospheres (Canada)Creon 25 Minimicrospheres (Canada)

Pharmacology

Helps to digest and absorb fats, proteins, and carbohydrates from food.

Indications and Usage

Enzyme replacement therapy in patients who do not produce enough pancreatic enzymes because of cystic fibrosis, chronic pancreatitis, postpancreatectomy, ductal obstructions caused by cancer of pancreas or common bile duct, pancreatic insufficiency; treatment of steatorrhea of malabsorption syndrome; postgastrectomy or after GI surgery; pancreatic function testing.

Contraindications

Hypersensitivity to pork protein or enzymes; acute pancreatitis; acute exacerbations of chronic pancreatic disease.

Dosage and Administration

Dosage is adjusted based on severity of the exocrine pancreatic enzyme deficiency. Dosage recommendation varies with the brand and formulation. Take capsules or tablets with meals or snacks.

Pancrecarb , Ultrase , Ultrase MTAdults

PO Start with 1 or 2 capsules with each meal or snack.

KutraseAdults

PO Take 1 capsule with each meal or snack.

Pancrease MT 4Children (older than 4 yr of age)

PO Start with 400 lipase units/kg/meal up to a max of 2,500 lipase units/kg/meal.

Children (younger than 4 yr of age)

PO Start with 1,000 lipase units/kg with each meal up to a max of 2,500 lipase units with each meal.

Children (up to 12 mo of age)

PO 2,000 to 4,000 lipase units per 120 mL of formula or breast milk.

PancrelipaseAdults

PO 4,000 to 20,000 lipase units with each meal and with snacks.

Children (7 to 12 yr of age)

PO 4,000 to 12,000 lipase units with each meal and with snacks.

Children (1 to 6 yr of age)

PO 4,000 to 8,000 lipase units with each meal and 4,000 units with each snack.

Children (6 mo to younger than 1 yr of age)

PO 2,000 lipase units with each meal.

Creon 5Adults and Children (older than 6 yr of age)

PO Usual starting dose is 2 to 4 capsules with each meal or snack.

Children (younger than 6 yr of age)

PO Start with 1 to 2 capsules with each meal or snack. Select exact dose based on clinical experience with this age group.

Cystic fibrosis patients

PO Usual doses are 1,500 to 3,000 lipase units/kg with each meal (max, 6,000 lipase units/kg/meal).

Creon 10Adults and Children (older than 6 yr of age)

PO Usual starting dose is 1 to 2 capsules with each meal or snack.

Children (younger than 6 yr of age)

PO Usual starting dose is up to 1 capsule with each meal or snack.

Cystic fibrosis patients

PO Usual doses are 1,500 to 3,000 lipase units/kg with each meal (max, 6,000 lipase units/kg/meal).

Creon 20Adults and Children (older than 6 yr of age)

PO Start with 1 capsule with each meal or snack.

Children (younger than 6 yr of age)

PO Select exact dose based on clinical experience with this age group.

Cystic fibrosis patients

PO Usual starting doses are 1,500 to 3,000 lipase units/kg with each meal (max, 6,000 lipase units/kg/meal).

Panokase , Plaretase , Viokase (tablets)Cystic fibrosis and chronic pancreatitis patients

PO Dose ranges from 8,000 to 32,000 lipase units (1 to 4 tablets [ Plaretase , Panokase , Viokase 8 ] or 1 to 2 tablets [ Viokase 16 ]) with each meal.

Pancreatectomy or obstruction of pancreatic ducts

PO 1 to 2 tablets ( Plaretase , Panokase , Viokase 8 ) or 1 tablet ( Viokase 16 ) every 2 h.

Viokase (powder)Cystic fibrosis

PO 0.7 g (¼ tsp) with each meal.

General Advice

• Do not crush or allow patient to chew enteric-coated formulations.
• Give with or before meals.
• If powder spills on hands, wash with soap and water immediately.
• If patient has difficulty swallowing capsule, open capsule and shake onto small quantity of soft, non-hot food (eg, applesauce, gelatin) that does not require chewing. Have patient swallow immediately without chewing to avoid irritating GI mucosa. Follow with glass of juice or water.
• Be careful not to inhale powder, which can irritate mucosal surfaces and cause asthma attack.

Storage/Stability

Store at controlled room temperature (59° to 86°F) in tightly closed container. Protect from moisture.

Drug Interactions

Antacids

Calcium carbonate or magnesium hydroxide may negate beneficial effect of enzymes.

Iron

Serum iron response to oral iron may be decreased with concomitant pancreatic enzyme administration.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Perianal irritation.

GI

Colonic strictures; diarrhea; abdominal pain; intestinal obstruction; vomiting; intestinal stenosis; constipation; flatulence; nausea; bloating; cramping.

Miscellaneous

Hypersensitivity reaction.

Precautions

Pregnancy

Category B ( Pancrease MT ); Category C ( Creon , Kutrase , Pancrelipase , Panokase , Plaretase , Ultrase , Ultrase MT , Viokase ).

Lactation

Undetermined.

Asthma

Inhalation of airborne pancrelipase powder can precipitate asthma attack.

Colonic strictures

Colonic strictures reported primarily in cystic fibrosis patients often at dosages above the recommended range.

Skin irritation

Contact of pancrelipase with skin can cause irritation.

Overdosage

Symptoms

Nausea, vomiting, abdominal cramps, diarrhea, hyperuricosuria, hyperuricemia.

Patient Information

• Tell patient not to change brands without notifying health care provider. Products are not bioequivalent.
• Advise patient not to take pancrelipase with antacid containing calcium carbonate or magnesium hydroxide.
• Stress to patient the importance of taking drug before or with meals to enhance effectiveness of drug.
• Instruct patient to avoid inhaling powder to reduce chance of irritating mucous membranes or precipitating asthma attack.
• Advise patient to follow any special dietary recommendations from health care provider or dietitian.

Copyright © 2009 Wolters Kluwer Health.