Pancrelipase

Reviewed on 3/28/2022

What Is Pancrelipase and How Does It Work?

Pancrelipase is a prescription medication used to treat partial or complete exocrine pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic obstruction, and other pancreatic diseases. 

What Are Dosages of Pancrelipase?

Adult and pediatric dosage

Lipase/protease/amylase

(KU=1000 units)

Capsule, delayed-release (contains enteric-coated microspheres)

  • Creon
    • 3KU/9.5KU/15KU
    • 6KU/19KU/30KU
    • 12KU/38KU/60KU
    • 24KU/76KU/120KU
    • 36KU/114KU/180KU
  • Capsule, delayed-release (contains enteric-coated micro tablets)
  • Pancreaze
    • 4.2KU/10KU/17.5KU
    • 10.5KU/25KU/43.75KU
    • 16.8KU/40KU/70KU
    • 21KU/37KU/61KU
  • Capsule, delayed-release (contains enteric-coated minitablets)
  • Ultresa
    • 13.8KU/27.6KU/27.6KU
    • 20.7KU/41.4KU/41.4KU
    • 23KU/46KU/46KU
  • Tablet
  • Viokace
    • 10.44KU/39.15KU/39.15KU
    • 20.88KU/78.3KU/78.3KU
  • Capsule, delayed-release (contains enteric-coated microspheres)
  • Pertzye
    • 4KU/14.375KU/15.125KU
    • 8KU/28.75KU/30.25KU
    • 16KU/57.5KU/60.5KU
    • 24KU/86.25KU/90.75KU
  • Capsule, delayed-release (contains enteric-coated beads)
  • Zenpep
    • 3KU/10KU/16KU
    • 5KU/17KU/27KU
    • 10KU/34KU/55KU
    • 15KU/51KU/82KU
    • 20KU/68KU/109KU
    • 25KU/85KU/136KU
  • Exocrine Pancreatic Insufficiency
  • Adult dosage
    • Cystic fibrosis guidelines: Generally, start 500 lipase units/kg orally per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or less than 4000 lipase units/g fat ingested per day  
    • Administer 50% of meal dose with snacks
    • High-dose Creon: In 1 clinical trial described in the prescribing information, adults received a dose of 72,000 lipase units/meal while consuming at least 100 g of fat/day for chronic pancreatitis or pancreatectomy; lower starting doses (ie, 500 lipase units/kg/meal) are consistent with Cystic Fibrosis guidelines
  • Viokace
    • Generally, start 500 lipase units/kg orally per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or less than 4000 lipase units/g fat ingested per day  
    • Administer 50% of meal dose with snacks
    • Viokace should be administered with a PPI
    • Pediatric dosage
    • Creon/Zenpep
      • Children below 12 months: 3000 lipase units/kg/120 mL of formula or per breastfeeding; administer before feeding; capsule contents should not be mixed directly in formula or breast milk
      • Children between 1 to 3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
      • Children above 4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
    • Pancreaze
      • Children below 12 months: 2000-4000 lipase units/kg/120 mL of formula or per breastfeeding; administer before feeding; capsule contents should not be mixed directly in formula or breast milk 
      • Children between 1 to 3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
      • Children above 4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
      • Not to exceed 10,000 unit lipase/kg/day or less than 4,000 lipase unites/g fat ingested daily
    • Pertzye
      • Children below 12 months: 4000 lipase units/kg/120 mL of formula or per breastfeeding; administer before feeding; capsule contents should not be mixed directly in formula or breast milk
      • Children between 1 to 4 years and weight more than 8 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
      • Children above 4 years and weight more than 16 kg: Initiate at 500 lipase units/kg per meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
    • Ultresa
      • Children between 1 to 4 years and weight more than 14 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day 
      • Children above 4 years and weight more than 28 kg: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or less than 4000 lipase units/g fat ingested per day
    • Viokace
      • Safety and effectiveness not established
      • Recommendations from Cystic Fibrosis Foundation Consensus Report
      • Infants below 2 years are 2000-5000 lipase units/120 mL feeding; as the infant grows, adjust dose not to exceed 2500 lipase units/kg/feeding (or 10,000 lipase units/kg/day)
      • In general, daily requirements of 500-4000 lipase units/g of fat are required.

Dosage Considerations – Should be Given as Follows: 

  • See “Dosages”

SLIDESHOW

Super Tips to Boost Digestive Health: Bloating, Constipation, and More See Slideshow

What Are Side Effects Associated with Using Pancrelipase?

Common side effects of Pancrelipase include:

  • abdominal pain/cramping,
  • bloating,
  • headache,
  • weight loss,
  • early satiety,
  • flatulence,
  • nausea,
  • vomiting,
  • dyspepsia,
  • cough,
  • diarrhea, and
  • constipation.

Serious side effects of Pancrelipase include:

Rare side effects of Pancrelipase include:

  • none 
This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Pancrelipase?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

What Are Warnings and Precautions for Pancrelipase?

Contraindications

  • Documented hypersensitivity

Effects of drug abuse

  • None

Short-Term Effects

  • See “What Are Side Effects Associated with Using Pancrelipase?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Pancrelipase?”

Cautions

  • Avoid exceeding maximum dose due to risk of fibrosing colonopathy; more than or equal to 6,000 lipase units/kg per meal associated with colonic stricture, indicative of fibrosing colonopathy, particularly in children below 12 years
  • Swallow pills as chewing or retaining in the mouth may cause oral mucosa irritation; do not chew, crush or mix in foods having a pH above 4.5
  • Monitor uric acid levels in patients with gout, hyperuricemia, or renal impairment due to risk of hyperuricemia
  • Caution in patients with known allergy or porcine proteins
  • Do not exceed above 2,500 units/kg per meal (or more than 10,000 lipase units/kg per day or more than 4000 lipase units/g fat ingested per day)
  • Avoid inhalation of powder
  • Theoretical risk of viral transmission

Pregnancy and Lactation

  • Use with caution if the benefits outweigh the risks during pregnancy.
  • Lactation
    • Unknown

QUESTION

Pancreatitis is inflammation of an organ in the abdomen called the pancreas. See Answer
References
Medscape. Pancrelipase.

https://reference.medscape.com/drug/creon-pancreaze-pancrelipase-342069#0

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