From the Guidelines
The recommended initial dose of pancreatic enzyme replacement therapy (PERT) such as pancrelipase is typically 500 units of lipase per kilogram of body weight per meal, and 250 units of lipase per kilogram of body weight per snack, as indicated by the most recent guidelines 1.
Key Considerations for Administration
- Administration should occur during or immediately before each meal and snack, with the capsules swallowed whole with sufficient liquid.
- For patients who cannot swallow capsules, such as young children, the contents can be sprinkled on acidic soft foods like applesauce, but should not be crushed or chewed as this may reduce effectiveness and irritate the oral mucosa.
- Dosing should be individualized based on clinical symptoms, with adjustments made according to fat content of meals, severity of maldigestion, and response to therapy.
Maximum Daily Dose
- The maximum daily dose typically should not exceed 10,000 units of lipase per kilogram of body weight per day to avoid potential complications like fibrosing colonopathy, as supported by recent clinical practice updates 1.
Mechanism and Benefits
- PERT works by replacing deficient digestive enzymes (lipases, proteases, and amylases) that are normally produced by the pancreas, thereby improving the digestion and absorption of fats, proteins, and carbohydrates in patients with exocrine pancreatic insufficiency due to conditions such as chronic pancreatitis, cystic fibrosis, or pancreatic surgery.
- The use of PERT has been shown to improve outcomes, including reducing steatorrhea and gastrointestinal symptoms, and enhancing nutritional status, as highlighted in recent guidelines and studies 1.
Monitoring and Adjustment
- The efficacy of PERT should be evaluated by the relief of gastrointestinal symptoms and the improvement of nutritional parameters, with adjustments made as necessary to optimize therapy, as recommended by clinical guidelines 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Important Dosing Information (2. 1) CREON is a mixture of enzymes including lipases, proteases, and amylases, and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Recommended Dosage (2. 2) Adult and Pediatric Patients Greater than 12 Months: The recommended initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years and older. 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years Preparation and Administration Instructions (2. 3) Swallow capsules whole. For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt).
The recommended initial dose of pancreatic enzymes, such as pancrelipase, for patients requiring supplementation is:
- 500 lipase units/kg/meal for adult and pediatric patients 4 years and older
- 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy
- 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years The administration of pancreatic enzymes should be as follows:
- Swallow capsules whole
- For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt) 2
From the Research
Pancreatic Enzyme Supplementation
The recommended initial dose and administration of pancreatic enzymes, such as pancrelipase, for patients requiring supplementation are as follows:
- The initial dosage is 20,000 to 40,000 units of lipase taken once or twice per meal, with dose adjustment afterward as needed 3.
- The dose can be raised, and a proton-pump inhibitor can be added on 3.
- Administration of 25,000 to 40,000 units of lipase per meal using pH-sensitive pancreatin microspheres is also recommended 4.
Forms of Pancreatic Enzymes
Various forms of pancreatic enzymes are available, including:
- Enterically coated micropellets or minitablets with a diameter of 2 mm or less 3.
- Pancrelipase formulations, such as Creon®, Zenpep®, and Pancreaze®, which have been approved by the FDA as effective treatments for pancreatic exocrine insufficiency 5.
- Microspheres, which have been found to be as effective as traditional enzyme supplements 6.
- A novel pancreatic enzyme product, TheraCLEC-Total (TCT), which is a proprietary formulation of microbial-derived lipase, protease, and amylase 7.
Dosage Adjustment
Dosage adjustment may be necessary to achieve optimal effectiveness, and individualization of the timing of treatment initiation and dosage requirements is needed 5, 4.