pancreatin
Creon, Digepepsin, Hi-Vegi-Lip, 4X Pancreatin, 8X Pancreatin, Pancrezyme 4X

Pharmacologic classification: pancreatic enzyme
Therapeutic classification: digestant
Pregnancy risk category C


Available forms
Available without a prescription
Hi-Vegi-Lip
Tablets (enteric-coated): 2,400 mg pancreatin; 4,800 units lipase; 60,000 units protease; 60,000 units amylase
4X Pancreatin, Pancrezyme 4X
Tablets (enteric-coated): 2,400 mg pancreatin; 12,000 units lipase; 60,000 units protease; 60,000 units amylase
8X Pancreatin
Tablets (enteric-coated): 7,200 mg pancreatin; 22,500 units lipase; 180,000 units protease; 180,000 units amylase
Available by prescription only :
Creon
Capsules: 300 mg pancreatin, 8,000 units lipase, 13,000 units protease, 30,000 units amylase
Digepepsin
Tablets: 300 mg pancreatin

Indications and dosages
 Exocrine pancreatic secretion insufficiency, digestive aid in cystic fibrosis, steatorrhea, and other disorders of fat metabolism secondary to insufficient pancreatic enzymes. Adults and children: 1 to 2 tablets or capsules P.O. with each meal.

Pharmacodynamics
Digestive action: Proteolytic, amylolytic, and lipolytic enzymes enhance the digestion of proteins, starches, and fats. Drug is sensitive to acids and is more active in neutral or slightly alkaline environments.

Pharmacokinetics
Absorption: Not absorbed; acts locally in GI tract.
Distribution: None.
Metabolism: None.
Excretion: Excreted in feces.

Route Onset Peak Duration
P.O. Unknown Unknown 1-2 hr


Contraindications and precautions
Contraindicated in patients hypersensitive to drug or pork protein or enzymes. Also contraindicated in those with acute pancreatitis or acute exacerbations of chronic pancreatitis. Use cautiously in pregnant or breast-feeding women.

Interactions
Drug-drug. Antacids that contain calcium or magnesium: May reduce pancreatin activity. Don’t administer together.
Products that contain iron: Decreases absorption of these drugs. Monitor patient for decreased effectiveness.

Adverse reactions
GI: perianal irritation, nausea, diarrhea (with high doses).
Skin: rash.
Other: allergic reactions.

Effects on lab test results
• May increase uric acid levels.

Overdose and treatment
Toxicity may cause hyperuricuria, hyperuricemia, diarrhea, abdominal cramps, and transient intestinal upset.
 If needed, provide symptomatic treatment.

Special considerations
• For maximal effect, give dose just before or during a meal.
• Tablets may not be crushed or chewed; follow with a glass of water to ensure complete swallowing.
• Diet should balance fat, protein, and starch intake properly to avoid indigestion. Dosage varies according to degree of maldigestion and malabsorption, amount of fat in diet, and enzyme activity of individual preparations.
• Adequate replacement decreases number of bowel movements and improves stool consistency.
• Use only after confirmed diagnosis of exocrine pancreatic insufficiency. Not effective in GI disorders unrelated to pancreatic enzyme deficiency.
• Enteric coating may reduce availability of enzyme in upper portion of jejunum and shouldn’t be chewed. Swallow promptly to avoid mucosal irritation.

Patient education
• Explain use of drug, and advise storage away from heat and light.
• Make sure patient or family understands special dietary instructions for the patient’s disease.
• Advise against changing brands without medical approval.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use