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Identification
- Summary
Pancrelipase amylase is a lipase used to treat pancreatic exocrine insufficiency.
- Brand Names
- Cotazym, Creon, Pancrease MT, Pancreaze, Pertzye, Viokace, Zenpep
- Generic Name
- Pancrelipase amylase
- DrugBank Accession Number
- DB11065
- Background
Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands.4 The amylases are enzymes that help in the chemical process of digestion by hydrolizing starch into more available saccharide forms.3 The pancrelipase amylase is a single polypeptide chain containing two SH groups and four disulfide bridges.6 The pancrelipase mixture, including pancrelipase amylase, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.5
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- 57086.0 Da
- Sequences
>sp|P00690|AMYP_PIG Pancreatic alpha-amylase OS=Sus scrofa OX=9823 GN=AMY2 PE=1 SV=3 MKLFLLLSAFGFCWAQYAPQTQSGRTSIVHLFEWRWVDIALECERYLGPKGFGGVQVSPP NENIVVTNPSRPWWERYQPVSYKLCTRSGNENEFRDMVTRCNNVGVRIYVDAVINHMCGS GAAAGTGTTCGSYCNPGNREFPAVPYSAWDFNDGKCKTASGGIESYNDPYQVRDCQLVGL LDLALEKDYVRSMIADYLNKLIDIGVAGFRIDASKHMWPGDIKAVLDKLHNLNTNWFPAG SRPFIFQEVIDLGGEAIQSSEYFGNGRVTEFKYGAKLGTVVRKWSGEKMSYLKNWGEGWG FMPSDRALVFVDNHDNQRGHGAGGASILTFWDARLYKVAVGFMLAHPYGFTRVMSSYRWA RNFVNGQDVNDWIGPPNNNGVIKEVTINADTTCGNDWVCEHRWRQIRNMVWFRNVVDGQP FANWWANGSNQVAFGRGNRGFIVFNNDDWQLSSTLQTGLPGGTYCDVISGDKVGNSCTGI KVYVSSDGTAQFSISNSAEDPFIAIHAESKL
Download FASTA Format- Synonyms
- 1,4-alpha-D-Glucan glucanohydrolase
- alpha-Amylase
- alpha-amylase (porcine)
- Alpha-amylase swine pancreas
- alpha-Amylases
- Amylase A
- Amylase AD
- Amylase, pancreatic
- Porcine pancreas alpha-amylase
Pharmacology
- Indication
Please refer to Pancrelipase.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase protease (DB11066), Pancrelipase lipase (DB13147) •••••••••••• •••••••• ••••••• •••••• Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase lipase (DB13147), Dimethicone (DB11074), Pancrelipase protease (DB11066) •••••••••••• •••••••• •••••• ••••••• Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase protease (DB11066) •••••••••••• ••••••• ••••••• Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase protease (DB11066) •••••••••••• - Contraindications & Blackbox Warnings
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Please refer to Pancrelipase.
- Mechanism of action
The pancrelipase amylase acts by replacing the lack of physiological amylase. The amylase activity is done by the hydrolyzation of the alpha 1-4 linkages in the polysaccharides of three or more linked glucose units. The linkages alpha 1-6 are not hydrolyzed and thus, the starch is only reduced to lower molecule compounds.6
Target Actions Organism ADietary starch cleavageHumans - Absorption
Please refer to Pancrelipase.
- Volume of distribution
Please refer to Pancrelipase.
- Protein binding
Please refer to Pancrelipase.
- Metabolism
Please refer to Pancrelipase.
- Route of elimination
Please refer to Pancrelipase.
- Half-life
Please refer to Pancrelipase.
- Clearance
Please refer to Pancrelipase.
- Adverse Effects
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Please refer to Pancrelipase.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Take with food.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Product Images
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image BIOGROW® VITE Pancrelipase amylase (12.5 mg) + Ascorbic acid (25 mg) + Beta carotene (500 IU) + Biotin (50 mcg) + Boron (50 mcg) + Bromelains (12.5 mg) + Calcium (2.25 mg) + Cholecalciferol (200 IU) + Choline (8.5 mg) + Chromium (10 mcg) + Copper (34 mcg) + Cyanocobalamin (2 mcg) + Folic acid (125 mcg) + Inositol (1.75 mg) + Iodine (56 mcg) + Iron (2 mg) + Magnesium (1.5 mg) + Manganese cation (750 mcg) + Molybdenum (9 mcg) + Nicotinamide (10 mg) + Pantothenic acid (10 mg) + Papain (12.5 mg) + Phosphorus (2.5 mg) + Potassium (2.5 mg) + Pyridoxine (5 mg) + Riboflavin (2 mg) + Selenium (17 mcg) + Silicon (9 mcg) + Thiamine (2 mg) + Thiamine (2.5 mg) + Vanadium (4 mcg) + Vitamin A (2500 IU) + Vitamin E (15 IU) + Zinc (2 mg) Tablet Oral UNISON NUTRACEUTICALS SDN. BHD. 2020-09-08 Not applicable Malaysia 
Chewable Enzymes Tablets Pancrelipase amylase (5 mg) + Bromelains (15 mg) + Papain (100 mg) Tablet Oral Gahler Enterprises Ltd. 1988-12-31 2002-07-17 Canada 
Cotazym Pancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units) + Pancrelipase protease (35000 units) Capsule Oral Organon Canada Inc. 1973-12-31 Not applicable Canada Cotazym Ecs 20 Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units) + Pancrelipase protease (100000 units) Capsule, delayed release Oral Organon Canada Inc. 1989-12-31 Not applicable Canada Cotazym Ecs 4 Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit) + Pancrelipase protease (11000 unit) Capsule Oral Merck Ltd. 1997-08-18 2012-01-23 Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Creon 10 Minimicrospheres Pancrelipase amylase (33200 [USP'U]/1) + Pancrelipase lipase (10000 [USP'U]/1) + Pancrelipase protease (37500 [USP'U]/1) Capsule, delayed release Oral Physicians Total Care, Inc. 2006-09-12 2009-09-30 US 
Creon 20 Minimicrospheres Pancrelipase amylase (66400 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) + Pancrelipase protease (75000 [USP'U]/1) Capsule, delayed release Oral Physicians Total Care, Inc. 1995-01-17 2009-09-30 US Pancrelipase Pancrelipase amylase (56000 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) + Pancrelipase protease (44000 [USP'U]/1) Capsule, delayed release Oral Kaiser Foundations Hospitals 2010-02-01 2010-12-31 US
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- YOJ58O116E
- CAS number
- 9000-90-2
References
- General References
- Nakajima K, Oshida H, Muneyuki T, Kakei M: Pancrelipase: an evidence-based review of its use for treating pancreatic exocrine insufficiency. Core Evid. 2012;7:77-91. doi: 10.2147/CE.S26705. Epub 2012 Jul 19. [Article]
- Dominguez Munoz JE: Diagnosis of chronic pancreatitis: Functional testing. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):233-41. doi: 10.1016/j.bpg.2010.03.008. [Article]
- Silverman R. (2002). The organic chemistry of enzyme-catalyzed reactions. Academic Press.
- Creon monograph [Link]
- FDA approval [Link]
- Amylase product information [Link]
- FDA reports [Link]
- CENTER FOR DRUG EVALUATION AND RESEARCH- 20755 [Link]
- EMA reports [Link]
- INVIMA Product Authorization: Panzytrat (pancreatic lipase/amylase/protease) gastroresistant tablets [Link]
- TITCK Product Information: Fermento (pancreatic lipase/amylase/protease with dimethicone) oral capsules [Link]
- External Links
- FDA label
- Download (483 KB)
- MSDS
- Download (274 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Not Available Pancreatic Fistula 1 somestatus stop reason just information to hide Not Available Completed Not Available Pancreatitis, Chronic 1 somestatus stop reason just information to hide Not Available Completed Basic Science Pancreatitis 1 somestatus stop reason just information to hide Not Available Completed Treatment Cystic Fibrosis (CF) 1 somestatus stop reason just information to hide Not Available Completed Treatment Obesity 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Capsule, delayed release pellets Oral Capsule, delayed release Oral Capsule, delayed release pellets Not applicable Capsule, delayed release pellets Granule, delayed release Oral Capsule Oral Tablet, coated Oral Capsule, coated pellets Oral Capsule, extended release Oral Capsule, coated Oral 22500 U Ph.Eu Tablet Cutaneous Tablet Oral Powder Oral - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US9198871 No 2015-12-01 2030-02-07 US US8562979 No 2013-10-22 2028-02-20 US US8562980 No 2013-10-22 2028-02-20 US US8562981 No 2013-10-22 2028-02-20 US US8221747 No 2012-07-17 2028-02-20 US US8562978 No 2013-10-22 2028-02-20 US US8246950 No 2012-08-21 2028-02-20 US US7658918 No 2010-02-09 2028-02-20 US
Properties
- State
- Solid
- Experimental Properties
Property Value Source water solubility 1 mg/ml Monograph isoelectric point 5.25-5.95 Pasero L. et al. 1979. HAL archives ouvertes
Targets
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1. Dietary starch
Yes
Cleavage
References
- Amylase product information [Link]
Drug created at December 03, 2015 16:51 / Updated at May 21, 2021 10:21