Pancrelipase amylase

识别

总结

Pancrelipase amylaseis 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.⁴The amylases are enzymes that help in the chemical process of digestion by hydrolizing starch into more available saccharide forms.³The pancrelipase amylase is a single polypeptide chain containing two SH groups and four disulfide bridges.⁶The 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 toPancrelipase.

Reduce drug development failure rates

Build, train, & validate machine-learning models
with evidence-based and structured datasets.

See how

Build, train, & validate predictive machine-learning models with structured datasets.

See how

Associated Conditions

• Exocrine Pancreatic Insufficiency

Contraindications & Blackbox Warnings

Avoid life-threatening adverse drug events

Improve clinical decision support with information oncontraindications & blackbox warnings, population restrictions, harmful risks, & more.

Learn more

Avoid life-threatening adverse drug events & improve clinical decision support.

Learn more

Pharmacodynamics

Please refer toPancrelipase.

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	cleavage	Humans

Absorption

Please refer toPancrelipase.

Volume of distribution

Please refer toPancrelipase.

Protein binding

Please refer toPancrelipase.

Metabolism

Please refer toPancrelipase.

Route of elimination

Please refer toPancrelipase.

Half-life

Please refer toPancrelipase.

Clearance

Please refer toPancrelipase.

Adverse Effects

Improve decision support & research outcomes

With structured adverse effects data, including:blackbox warnings, adverse reactions, warning & precautions, & incidence rates.

Learn more

Improve decision support & research outcomes with our structured adverse effects data.

Learn more

Toxicity

Please refer toPancrelipase.

Pathways

Not Available

Pharmacogenomic Effects/ADRsBrowse all" title="" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">

Not Available

Interactions

Drug InteractionsLearn More" title="" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">

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 regions

我们的数据集公关ovide approved product information including:
dosage, form, labeller, route of administration, and marketing period.

Access now

Access drug product information from over 10 global regions.

Access now

Product Images

Previous Next

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Chewable Enzymes Tablets	Pancrelipase amylase(5 mg)+Bromelains(15 mg)+Papain(100 mg)	Tablet	Oral	Gahler Enterprises Ltd.	1988-12-31	2002-07-17
Cotazym	Pancrelipase amylase(40000 units)+Pancrelipase lipase(10000 units)+Pancrelipase protease(35000 units)	Capsule	Oral	Organon Canada Inc.	1973-12-31	Not applicable
CotazymEcs 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
CotazymEcs 4	Pancrelipase amylase(11000 unit)+Pancrelipase lipase(4000 unit)+Pancrelipase protease(11000 unit)	Capsule	Oral	Merck Ltd.	1997-08-18	2012-01-23
CotazymEcs 8	Pancrelipase amylase(42000 units)+Pancrelipase lipase(10800 units)+Pancrelipase protease(45000 units)	Capsule, delayed release	Oral	Organon Canada Inc.	1980-12-31	Not applicable
Creon	Pancrelipase amylase(15000 [USP'U]/1)+Pancrelipase lipase(3000 [USP'U]/1)+Pancrelipase protease(9500 [USP'U]/1)	Capsule, delayed release	Oral	AbbVie Inc.	2009-04-30	Not applicable
Creon	Pancrelipase amylase(60000 [USP'U]/1)+Pancrelipase lipase(12000 [USP'U]/1)+Pancrelipase protease(38000 [USP'U]/1)	Capsule, delayed release pellets	Oral	Physicians Total Care, Inc.	2009-09-29	Not applicable
Creon	Pancrelipase amylase(30000 [USP'U]/1)+Pancrelipase lipase(6000 [USP'U]/1)+Pancrelipase protease(19000 [USP'U]/1)	Capsule, delayed release pellets	Oral	AbbVie Inc.	2009-04-30	Not applicable
Creon	Pancrelipase amylase(120000 [USP'U]/1)+Pancrelipase lipase(24000 [USP'U]/1)+Pancrelipase protease(76000 [USP'U]/1)	Capsule, delayed release pellets	Oral	AbbVie Inc.	2009-04-30	Not applicable
Creon	Pancrelipase amylase(60000 [USP'U]/1)+Pancrelipase lipase(12000 [USP'U]/1)+Pancrelipase protease(38000 [USP'U]/1)	Capsule, delayed release pellets	Oral	Atlantic Biologicals Corps.	2010-08-13	Not applicable

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
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
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

Categories

Drug Categories

• Amylases
• Amylases, antagonists & inhibitors
• Enzymes
• Enzymes and Coenzymes
• Glycoside Hydrolases
• Hydrolases

Chemical TaxonomyProvided byClassyfire

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

外部描述符

Not Available

Affected organisms

• Humans and other mammals

Chemical Identifiers

UNII

YOJ58O116E

CAS number

9000-90-2

参考文献

一般References

1. 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]
2. 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]
3. Silverman R. (2002). The organic chemistry of enzyme-catalyzed reactions. Academic Press.
4. Creon monograph [Link]
5. FDA approval [Link]
6. Amylase product information [Link]
7. FDA reports [Link]
8. CENTER FOR DRUG EVALUATION AND RESEARCH- 20755 [Link]
9. EMA reports [Link]
10. INVIMA Product Authorization: Panzytrat (pancreatic lipase/amylase/protease) gastroresistant tablets [Link]
11. TITCK Product Information: Fermento (pancreatic lipase/amylase/protease with dimethicone) oral capsules [Link]

External Links

RxNav

1427033

FDA label

Download (483 KB)

MSDS

Download (274 KB)

Clinical Trials

Clinical TrialsLearn More" title="" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Active Not Recruiting	治疗	Cystic Fibrosis (CF)/Pancreatitis, Chronic	1
4	Completed	治疗	Cystic Fibrosis (CF)	1
4	Completed	治疗	Cystic Fibrosis (CF)/Exocrine Pancreatic Insufficiency	2
4	Completed	治疗	Pancreatic Insufficiency	1
4	Completed	治疗	Pancreatitis, Chronic	1
4	Terminated	治疗	Exocrine Pancreatic Insufficiency	1
4	Terminated	治疗	Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)/Patients With Pancreatic Exocrine Insufficiency	1
4	Withdrawn	治疗	Exocrine Pancreatic Insufficiency	1
4	Withdrawn	治疗	Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2	1
3	Completed	治疗	Cystic Fibrosis (CF)/Exocrine Pancreatic Insufficiency	1

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	Oral
Powder	Oral

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
US9198871	No	2015-12-01	2030-02-07
US8562979	No	2013-10-22	2028-02-20
US8562980	No	2013-10-22	2028-02-20
US8562981	No	2013-10-22	2028-02-20
US8221747	No	2012-07-17	2028-02-20
US8562978	No	2013-10-22	2028-02-20
US8246950	No	2012-08-21	2028-02-20
US7658918	No	2010-02-09	2028-02-20

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

Build, predict & validate machine-learning models

Use our structured and evidence-based datasets tounlock new
insights and accelerate drug research.

Learn more

Use our structured and evidence-based datasets to unlock new insights and accelerate drug research.

Learn more

1. Dietary starch

Kind

Group

Organism

Humans

Pharmacological action

Yes

Actions

Cleavage

参考文献

1. Amylase product information [Link]

×

Identify potential medication risks

Easily compare up to 40 drugs with our drug interaction checker.

Get severity rating, description, and management advice.

Learn more

Drug created at December 03, 2015 16:51 / Updated at May 21, 2021 10:21