No

Enzyme

Replacement therapy in symptomatic treatment of malabsorption syndrome caused by pancreatic insufficiency

C

Hypersensitivity to pancrelipase or any component, pork protein

Pancrelipase is inactivated by acids; use microencapsulated products whenever possible, since these products permit better dissolution of enzymes in the duodenum and protect the enzyme preparations from acid degradation in the stomach

1% to 10%: High doses:

Endocrine & metabolic: Hyperuricemia

Gastrointestinal: Nausea, cramps, constipation, diarrhea

Genitourinary: Hyperuricosuria

Ocular: Lacrimation

Respiratory: Sneezing, bronchospasm

<1%: Rash, shortness of breath, bronchospasm, irritation of the mouth

Symptoms of overdose include diarrhea, other transient intestinal upset, hyperuricosuria, hyperuricemia

Decreased effect: Calcium carbonate, magnesium hydroxide

Increased effect: H₂-antagonists (eg, ranitidine, cimetidine)

Replaces endogenous pancreatic enzymes to assist in digestion of protein, starch and fats

Absorption: Not absorbed, acts locally in GI tract

Elimination: In feces

Oral:

Children <1 year: Start with 1/8 teaspoonful with feedings

Adults: 0.7 g with meals

Enteric coated microspheres and microtablets: The following dosage recommendations are only an approximation for initial dosages. The actual dosage will depend on the digestive requirements of the individual patient.

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: 4000-16,000 units of lipase with meals and with snacks or 1-3 tablets/capsules before or with meals and snacks; in severe deficiencies, dose may be increased to 8 tablets/capsules

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

Avoid taking with alkaline food (pH >5.5); may impair oral iron absorption; should be administered with meals

Oral: Swallow tablets and capsules whole; do not chew the microspheres or microtablets; retention in the mouth before swallowing may cause mucosal irritation and stomatitis; for infants give with small amount of formula

None reported

None reported

No information available to require special precautions

No effects or complications reported

Take before or with meals. Avoid taking with alkaline food. Do not chew, crush, or dissolve delayed release capsules; swallow whole. Do not inhale powder when preparing. You may experience some gastric discomfort. Report unusual joint pain or swelling, respiratory difficulty, or persistent GI upset. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Monitor stool fat content

Capsule:

Cotazym®: Lipase 8000 units, protease 30,000 units, amylase 30,000 units

Ku-Zyme® HP: Lipase 8000 units, protease 30,000 units, amylase 30,000 units

Lipram-PN16®: Lipase 16,000 units, protease 48,000 units, amylase 48, 000 units

Lipram-CR20®: Lipase 20,000 units, protease 75,000 units, amylase 66,400 units

Lipram-UL12®: Lipase 12,000 units, protease 39,000 units, amylase 39,000 units

Lipram-PN10®: Lipase 10,000 units, protease 30,000 units, amylase 30,000 units

Lipram-UL18®: Lipase 18,000 units, protease 58,500 units, amylase 58,500 units

Lipram-UL20®: Lipase 20,000 units, protease 65,000 units, amylase 65,000 units

Ultrase® MT12: Lipase 12,000 units, protease 39,000 units, amylase 39,000 units

Ultrase® MT20: Lipase 20,000 units, protease 65,000 units, amylase 65,000 units

Enteric coated microspheres (Pancrease®): Lipase 4000 units, protease 25,000 units, amylase 20,000 units

Enteric coated microtablets:

Pancrease® MT 4: Lipase 4500 units, protease 12,000 units, amylase 12,000 units

Pancrease® MT 10: Lipase 10,000 units, protease 30,000 units, amylase 30,000 units

Pancrease® MT 16: Lipase 16,000 units, protease 48,000 units, amylase 48,000 units

Pancrease® MT 20: Lipase 20,000 units, protease 44,000 units, amylase 56,000 units

Enteric coated spheres:

Cotazym-S®: Lipase 5000 units, protease 20,000 units, amylase 20,000 units

Pancrelipase, Protilase®: Lipase 4000 units, protease 25,000 units, amylase 20,000 units

Zymase®: Lipase 12,000 units, protease 24,000 units, amylase 24,000 units

Delayed release:

Creon® 10: Lipase 10,000 units, protease 37,500 units, amylase 33,200 units

Creon® 20: Lipase 20,000 units, protease 75,000 units, amylase 66,400 units

Powder (Viokase®): Lipase 16,800 units, protease 70,000 units, amylase 70,000 units per 0.7 g

Tablet:

Ilozyme®: Lipase 11,000 units, protease 30,000 units, amylase 30,000 units

Viokase®: Lipase 8000 units, protease 30,000 units, amylase 30,000 units

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.