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

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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

Contraindications

pregnancy-category C

safety in lactation ?

Dosage

  • 1-3 tabs PO with meals
  • do NOT chew capsules, microspheres or tablets

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

Adverse effects

Mechanism of action

More general terms

Additional terms

Components

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. 4.0 4.1 Prescriber's Letter 17(10): 2010 Approved Pancreatic Enzyme Products Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=261009&pb=PRL (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. 6.0 6.1 Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300622&pb=PRL (subscription needed) http://www.prescribersletter.com