From the Guidelines
The dose of pancreolipase for adults with pancreatic insufficiency should start at 40,000 USP units of lipase during each meal, with half of that dose for snacks, and can be adjusted based on meal size and fat content, as recommended by the most recent guidelines 1.
Key Considerations
- The initial dose of pancreolipase can be adjusted based on symptom control, particularly steatorrhea (fatty stools) 1.
- Pancreolipase should be taken during meals and snacks to maximize mixing and digestion of nutrients 1.
- The medication should not be crushed or chewed as this can irritate the mouth and reduce effectiveness.
- Dose adjustments should be made gradually based on symptom control, particularly steatorrhea (fatty stools) 1.
Clinical Evidence
- A recent study published in Gastroenterology in 2023 found that PERT should be taken during the meal, with the initial treatment of at least 40,000 USP units of lipase during each meal in adults and one-half of that with snacks 1.
- Another study published in the same journal in 2023 recommended that the dose of pancreolipase be titrated up as needed to reduce steatorrhea or gastrointestinal symptoms of maldigestion, with a maximal dose of 2500 units of lipase per kg per meal or 10,000 units of lipase per kg per day 1.
Patient Management
- Patients with pancreatic insufficiency should be monitored regularly to maximize patient compliance and specialist dietetic assessment should be sought in patients with underlying malnutrition 1.
- Dietary modifications, including a low-moderate fat diet with frequent smaller meals and avoiding very-low-fat diets, are also recommended 1.
From the FDA Drug Label
- 2 Recommended Dosage 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. 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 of age.
The dose of pancreolipase is 500-1000 lipase units/kg/meal for adult patients and 500-1000 lipase units/kg/meal for pediatric patients 4 years of age and older, with variations based on age and medical condition. For pediatric patients greater than 12 months to less than 4 years of age, the dose is 1000 lipase units/kg/meal. The dose for pediatric patients birth to 12 months of age is 3000 lipase units per 120 mL of formula or per breast-feeding 2.
- Key considerations:
- The dosage may need to be adjusted based on clinical symptoms and the degree of steatorrhea present.
- The total daily dosage should reflect approximately three meals plus two or three snacks per day.
- With each snack, administer approximately half the prescribed CREON dose for a meal.
From the Research
Dose of Pancreolipase
- The dose of pancreolipase is not explicitly mentioned in the provided studies 3, 4, 5, 6, 7.
- However, a study on comparative in vitro and in vivo studies of enteric-coated pancrelipase preparations for pancreatic insufficiency mentions that absorption of energy, nitrogen, and fat did not differ when comparing the three preparations at roughly pharmaceutically equivalent doses 5.
- The study also notes that when expressed per capsule of pancreatic supplement ingested, absorption reflected relative enzyme content, favoring the higher potency preparations 5.
- Another study mentions that the higher potency preparations were more effective per capsule and reduced capsule dosage is therefore attainable 5.
Enzyme Potency and Variation
- In vitro enzyme potency varied markedly between batches of the same brand, and a decline of up to 20% in amylase, lipase, and trypsin activity was noted over an 8-month period for each batch 5.
- The study suggests that this variation has clinical implications at times of represcription 5.
Clinical Implications
- The studies emphasize the importance of considering other conditions that require urgent surgical intervention, such as perforated viscus, even if serum amylase and lipase tests are abnormal 3, 7.
- The diagnostic performance of these tests decreases with the progression of time, and additional investigations should be performed if symptoms are suggestive of acute pancreatitis 3.