Pancreaze Dosage

Generic name: PANCRELIPASE LIPASE 4200[USP'U], PANCRELIPASE AMYLASE 24600[USP'U], PANCRELIPASE PROTEASE 14200[USP'U]
Dosage form: capsule, delayed release
Drug class: Digestive enzymes

Medically reviewed by Drugs.com. Last updated on Mar 19, 2024.

PANCREAZE is a mixture of enzymes including lipases, proteases, and amylases. PANCREAZE dosing is based on lipase units.

Use either an actual body weight or fat ingestion-based dosing scheme.
Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days.
Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation [see Warnings and Precautions (5.1)] .
The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed PANCREAZE dose for a meal.
Do not substitute other pancreatic enzyme products for PANCREAZE. When switching from another pancreatic enzyme product to PANCREAZE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.

Adult and Pediatric Patients Greater than 12 Months of Age

The recommended oral initial starting dosage is:

500 lipase units/kg/meal for adult and pediatric patients 4 years of age and older.
1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age.
If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or less than 4,000 lipase units/grams of fat ingested/day.
Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption including measures of nutritional status.

Pediatric Patients Birth to 12 Months of Age

The recommended oral dosage is 2,600 lipase units per 120 mL of formula or per breast-feeding.

Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following:

Take PANCREAZE with meals or snacks. If a dose is missed, take the next dose with the next meal or snack.
Swallow capsules whole.
For patients who are unable to swallow intact capsules, carefully open the capsules and sprinkle the entire contents on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce). Consume the entire mixture immediately.
Do not crush or chew PANCREAZE capsules or capsule contents.
Consume sufficient liquids (water or juice) to ensure complete swallowing of PANCREAZE capsules [see Warnings and Precautions (5.2)] .

Instruct caregivers of pediatric patients birth to 12 months of age of the following:

Immediately prior to each breast-feeding session or each administration of 120 mL of formula, carefully open one PANCREAZE capsule (containing 2,600 USP units of lipase) and administer the entire contents using one of the following two methods:
- Sprinkle on a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce) being careful not to crush the capsule contents. The entire mixture should be given to the infant immediately.
- Sprinkle the capsule contents directly into the infant's mouth.
Immediately administer additional breast milk or formula after PANCREAZE to ensure complete swallowing of the capsule contents.
Do not mix PANCREAZE capsule contents directly into a bottle of breast milk or formula.
Do not crush PANCREAZE capsule contents, and visually inspect the infant's mouth to ensure that no drug is retained in the mouth [see Warnings and Precautions (5.2)] .
If a dose is missed, administer the next dose with the next feeding.