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amylase/lipase/protease; amylase/endopeptidase/lipase; pancrelipase (Viokase, Pancrease, Cotazym-S, Ku-Zyme, Creon-10, Ultrase-MT, Ultresa, Viokace, Pancrecarb, Zypatt, Zenpep)

Classification: - Tradenames of FDA-approved products: - Creon & Zenpep were approved for marketing in 2009 - Pancreaze was approved in April 2010 [4] - Tradenames of other products in use before 2009 - Viokase, Pancrease, Cotazym-S, Ku-Zyme, Creon-10, Ultrase-MT Indications: - replacement therapy in symptomatic treatment of malabsorption secondary to pancreatic exocrine deficiency of organic origin Contraindications: pregnancy-category C safety in lactation ? Dosage: 1) 1-3 tabs PO with meals 2) do NOT chew capsules, microspheres or tablets - to avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained in the mouth 3) CREON should always be taken with food. Amylase/lipase/protease combinations - USP units - Combination lipase amylase protease Cotazyme-S 5000 20,000 20,000 Pancrease 4000 20,000 25,000 Pancrease-MT(4) 4000 12,000 12,000 Pancrease-MT(10) 10,000 30,000 30,000 Pancrease-MT(16) 16,000 48,000 48,000 Viokase 8000 30,000 30,000 Ultrase MT12 12,000 39,000 39,000 Ultrase MT18 18,000 58,500 58,500 Ultrase MT120 20,000 65,000 65,000 Storage: - pancrelipase (Creon (3000 units lipase only) - must be protected from moisture [6] Pharmacokinetics: elimination: Not absorbed. Monitor: - contains purines, monitor serum uric acid if appropriate - theoretical risk of viral transmission with all pancreatic enzyme products Adverse effects: 1) free of adverse effects at recommended dosage 2) excessive dose may cause - not common (1-10%) - nausea, cramping, diarrhea, lacrimation, hyperuricemia, hyperuricosuria, sneezing - uncommon (< 1%) - irritation of the mouth, dyspnea, bronchospasm, rash 3) fibrosing colonopathy - so not exceed the recommended dosage of 10,000 lipase units/kg/day To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained in the mouth. CREON should always be taken with food. Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with CREON. There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON. Mechanism of action: - contains a) lipase 10,000 units b) amylase 33,200 units c) protease 37,500 units

Related

pancreatic enzyme

General

digestive enzymes pharmacologic combination

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
  3. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  4. Prescriber's Letter 17(10): 2010 Approved Pancreatic Enzyme Products Detail-Document#: 261009 (subscription needed) http://www.prescribersletter.com
  5. FDA News Release: March 1, 2012 FDA approves two new pancreatic enzyme products to aid food digestion http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294143.htm
  6. Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: 300622 (subscription needed) http://www.prescribersletter.com

Components

amylase lipase protease; proteinase; endopeptidase