From the Research
The maximum dose of Creon (pancrelipase) is typically 10,000 lipase units per kg of body weight per meal, not to exceed 2,500 lipase units per kg per meal (or 4,000 lipase units per gram of fat ingested).
Key Considerations
- For snacks, half the mealtime dose is usually recommended.
- There is no absolute maximum daily dose, but doses above 10,000 units/kg/meal should be used with caution due to potential side effects.
- Creon dosing is individualized based on clinical symptoms, degree of maldigestion, and fat content of meals.
- The medication should be taken with every meal and snack containing fat to properly digest food.
- Higher doses may be needed for patients with cystic fibrosis, chronic pancreatitis, or pancreatic cancer who have more severe pancreatic insufficiency.
Safety and Efficacy
- Side effects like abdominal pain, gas, and constipation can occur at higher doses, and very high doses have been associated with fibrosing colonopathy, particularly in children with cystic fibrosis.
- Dosage adjustments should always be made under medical supervision, as evidenced by studies such as 1, which demonstrated the efficacy and safety of pancrelipase delayed-release capsules in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery.
Clinical Evidence
- A study published in 2011 2 found that pancrelipase delayed-release capsules were well tolerated over 6 months and resulted in statistically significant weight gain and reduced stool frequency in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery.
- Another study from 2009 3 demonstrated the efficacy and safety of Creon 24,000-unit capsules in subjects with exocrine pancreatic insufficiency due to cystic fibrosis.
- The most recent and highest quality study 1 supports the use of pancrelipase delayed-release capsules for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery, with a significant improvement in coefficient of fat absorption and coefficient of nitrogen absorption compared to placebo.