Pancrelipase Dosage

Usual Adult Dose for Pancreatic Exocrine Dysfunction

Initial: lipase 500 units/kg orally per meal.

Maintenance: lipase 400 to 2500 units/kg orally per meal. Give one-half the usual dose with each snack.

Usual Adult Dose for Cystic Fibrosis

Initial: lipase 500 units/kg orally per meal.

Maintenance: lipase 400 to 2500 units/kg orally per meal. Give one-half the usual dose with each snack.

Usual Adult Dose for Chronic Pancreatitis

8000 to 32,000 lipase USP orally with each meal.

In patients with pancreatectomy or obstruction of pancreatic ducts, lipase 8000 to 16,000 USP orally taken at 2-hour intervals or as directed by physician.

Usual Pediatric Dose for Pancreatic Exocrine Dysfunction

Less than 1 year:
2000 to 4000 units per 120 mL of formula, breast milk, or per breast-feeding

Greater than 1 to less than 4 years:
Initial dose: 1000 units/kg/meal
Dosage range: 1000 to 2500 units/kg/meal

Greater than or equal to 4 years:
Refer to adult dosing.

In cystic fibrosis, the powder is given as one-fourth teaspoonful (0.7 g) with meals.

Usual Pediatric Dose for Cystic Fibrosis

Less than 1 year:
2000 to 4000 units per 120 mL of formula, breast milk, or per breast-feeding

Greater than 1 to less than 4 years:
Initial dose: 1000 units/kg/meal
Dosage range: 1000 to 2500 units/kg/meal

Greater than or equal to 4 years:
Refer to adult dosing.

In cystic fibrosis, the powder is given as one-fourth teaspoonful (0.7 g) with meals.

Renal Dose Adjustments

No adjustments recommended

Liver Dose Adjustments

No adjustments recommended

Dose Adjustments

Dosage adjustments are highly individualized depending on the condition being treated. Dosage variations may exist depending on the pharmaceutical product being used.

Dose increases, if required, should be done slowly, with careful monitoring of response and symptomatology.

Pancrelipase dosage changes may be determined by the fat content of the diet. Approximately 8000 USP units of lipase may be administered for each 17 grams of dietary fat intake.

Precautions

It is not recommended that substitution occur between different pancreatic enzyme brand name or generic products (even though labeling states that they contain equivalent doses of enzymes) to help avoid problems due to differences in enzyme content, acid stability of the enteric coating, and dissolution pH. Therapeutic failures have been documented in patients receiving generic substitutes for brand name pancreatic enzymes.

Pancrelipase should not be crushed or chewed or mixed in foods having a pH greater than 4 to avoid disrupting the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity. For patients unable to swallow intact capsules, the capsules may be opened and the contents added in a small amount of acidic soft food with a pH of 4 or less, such as applesauce, at room temperature. The mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

Dialysis

Data not available

Other Comments

Pancrelipase should not be crushed or chewed or mixed in foods having a pH greater than 4 to avoid disrupting the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity. For patients unable to swallow intact capsules, the capsules may be opened and the contents added in a small amount of acidic soft food with a pH of 4 or less, such as applesauce, at room temperature. The mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

Patients should be advised to drink plenty of water with each dose. Patients will respond differently to the different brands of pancreatic enzymes replacement. Brand substitution should be avoided since therapeutic equivalence is variable between brands.

A case report of pancreatic enzyme intolerance (vomiting) in a child was resolved after implementation of a slow-paced desensitization program (duration 25 days).

See also...