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. Jump up to: 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. Jump up to: 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