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:
- 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
Dosage
- 1-3 tabs PO with meals
- 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
- 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
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
- free of adverse effects at recommended dosage
- excessive dose may cause
- not common (1-10%)
- uncommon (< 1%)
- irritation of the mouth, dyspnea, bronchospasm, rash
- 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
More general terms
Additional terms
Components
References
- ↑ The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
- ↑ Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ 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
- ↑ 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
- ↑ 6.0 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