Pancrelipase
CREON
What it isPorcine pancreatic enzyme replacement; exocrine pancreatic insufficiency.
Why this oneIt restores fat and protein digestion in cystic fibrosis, chronic pancreatitis and after pancreatectomy.
What limits itIt must be taken WITH food and not crushed, and acid destroys unprotected enzyme. Fibrosing colonopathy at very high doses in children.
FDA-approved for
- exocrine pancreatic insufficiency
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Exocrine pancreatic insufficiency | Adults & children ≥4 yr | 500 units/kg/meal (500–1,000 for chronic pancreatitis/pancreatectomy) | titrate to 2,500 units/kg/meal | 2,500 units/kg/meal (≤10,000 units/kg/day; ≤4,000 units/g fat/day) |
| Exocrine pancreatic insufficiency | Children >12 mo–<4 yr | 1,000 units/kg/meal | titrate to 2,500 units/kg/meal | 2,500 units/kg/meal |
| Exocrine pancreatic insufficiency | Infants birth–12 mo | 3,000 units per 120 mL formula or per breastfeeding |
Titration Changes may require an adjustment period of several days
Renal Undefined
Hepatic Undefined
Do not exceed 2,500 units/kg/meal, 10,000 units/kg/day, or 4,000 units/g fat/day without investigation
Instructions
- Take with meals and snacks (half the meal dose with each snack)
- Swallow capsules whole
- If unable to swallow, sprinkle contents on acidic soft food pH ≤4.5 (e.g., applesauce, banana, plain Greek yogurt) and consume immediately
- Do not crush or chew capsules or contents
- Consume sufficient liquid to ensure complete swallowing
Cautions
- Fibrosing colonopathy (high doses, prolonged use, pediatric CF)
- Irritation of oral mucosa if capsules crushed/chewed
- Hyperuricemia (contains purines)
- Theoretical risk of viral transmission (porcine source)
- Hypersensitivity reactions in patients sensitive to porcine proteins
Adverse reactions
- CF ≥7 yr: vomiting, dizziness, cough
- CF 4 mo–6 yr: vomiting, irritability, decreased appetite
- Chronic pancreatitis/pancreatectomy adults: hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis
Pregnancy Minimally absorbed systemically; no drug-associated risk identified.
Lactation Minimally absorbed; not expected to result in clinically relevant infant exposure.
NO BOXED WARNINGS
Principal riskEnteric coating must not be crushed, and it must be taken with every fat-containing meal
Classes and tags
Clinical profile
Mechanism of action: Pancrelipase ballicule
