perindopril indications/contra

Stem definitionDrug idCAS RN
angiotensin-converting enzyme inhibitors 2108 82834-16-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • perindopril
  • perindopril erbumine
  • perindopril arginine
An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.
  • Molecular weight: 368.47
  • Formula: C19H32N2O5
  • CLOGP: 1.21
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 95.94
  • ALOGS: -2.48
  • ROTB: 9

Drug dosage:

DoseUnitRoute
4 mg O

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1993 FDA SYMPLMED PHARMS LLC

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 905.97 43.72 271 1497 49412 3334679
Angioedema 511.54 43.72 135 1633 15000 3369091
Hypotension 379.63 43.72 142 1626 49372 3334719
Hyponatraemia 337.73 43.72 102 1666 18257 3365834
Hyperkalaemia 329.79 43.72 90 1678 11204 3372887
Fall 314.08 43.72 130 1638 58753 3325338
Cough 208.21 43.72 87 1681 39771 3344320
Metabolic acidosis 192.34 43.72 56 1712 8722 3375369
Drug interaction 185.12 43.72 84 1684 46728 3337363
Atrial fibrillation 179.75 43.72 68 1700 23873 3360218
Dyspnoea 175.95 43.72 105 1663 102829 3281262
Dizziness 173.58 43.72 94 1674 76418 3307673
Renal failure 168.74 43.72 71 1697 32869 3351222
Dehydration 154.04 43.72 67 1701 33582 3350509
Hypokalaemia 143.79 43.72 50 1718 13755 3370336
Orthostatic hypotension 141.24 43.72 39 1729 4997 3379094
Coma scale abnormal 138.61 43.72 29 1739 1136 3382955
Overdose 121.54 43.72 57 1711 33921 3350170
Cardiac murmur 119.28 43.72 30 1738 2673 3381418
Confusional state 115.46 43.72 57 1711 37941 3346150
Lower respiratory tract infection 109.04 43.72 34 1734 6635 3377456
Malaise 106.91 43.72 65 1703 65112 3318979
Lactic acidosis 101.05 43.72 33 1735 7467 3376624
Venous pressure jugular increased 99.03 43.72 16 1752 140 3383951
Loss of consciousness 96.80 43.72 46 1722 28101 3355990
Syncope 94.63 43.72 44 1724 25589 3358502
Dermatomyositis 84.68 43.72 17 1751 539 3383552
Swollen tongue 83.70 43.72 28 1740 6815 3377276
Hepatocellular injury 82.82 43.72 25 1743 4370 3379721
Cholestasis 82.17 43.72 26 1742 5311 3378780

Pharmacologic Action:

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SourceCodeDescription
ATC C09AA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, PLAIN
ACE inhibitors, plain
ATC C09BA04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and diuretics
ATC C09BB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C10BX11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX12 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX15 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
FDA EPC N0000175562 Angiotensin Converting Enzyme Inhibitor
MeSH PA D000806 Angiotensin-Converting Enzyme Inhibitors
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
CHEBI has role CHEBI:35457 EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor
CHEBI has role CHEBI:35674 antihypertensive agent

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Myocardial Infarction Prevention indication
Hyperkalemia contraindication 14140009
Acute cerebrovascular insufficiency contraindication 29322000
Angioedema contraindication 41291007 DOID:1558
Low blood pressure contraindication 45007003
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Kidney disease contraindication 90708001 DOID:2527
Disorder of connective tissue contraindication 105969002 DOID:65
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.23 acidic
pKa2 6.38 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
14MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
3.5MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
7MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
14MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
3.5MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
7MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
14MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL Jan. 21, 2018 NEW PRODUCT
3.5MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL Jan. 21, 2018 NEW PRODUCT
7MG PRESTALIA MARINA BIOTECH N205003 Jan. 21, 2015 RX TABLET ORAL Jan. 21, 2018 NEW PRODUCT

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Angiotensin-converting enzyme Enzyme INHIBITOR IC50 8.82 CHEMBL CHEMBL

External reference:

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IDSource
4021179 VUID
N0000148627 NUI
C0136123 UMLSCUI
6367 IUPHAR_LIGAND_ID
D00624 KEGG_DRUG
1964X464OJ UNII
107133-36-8 SECONDARY_CAS_RN
5987 INN_ID
DB00790 DRUGBANK_ID
4021179 VANDF
N0000007020 NDFRT
N0000148627 NDFRT
004018 NDDF
54552 RXNORM
129486004 SNOMEDCT_US
372916001 SNOMEDCT_US
d04440 MMSL
107807 PUBCHEM_CID
CHEMBL1581 ChEMBL_ID
CHEMBL1200343 ChEMBL_ID
CHEMBL1201368 ChEMBL_ID
C053500 MESH_SUPPLEMENTAL_RECORD_UI
CHEMBL3544986 ChEMBL_ID
D020913 MESH_DESCRIPTOR_UI
CHEBI:8024 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0110 TABLET 2 mg ORAL ANDA 17 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0111 TABLET 4 mg ORAL ANDA 17 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0112 TABLET 8 mg ORAL ANDA 17 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0527-1919 TABLET 4 mg ORAL NDA 18 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 0527-1920 TABLET 8 mg ORAL NDA 18 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 10135-599 TABLET 4 mg ORAL NDA 18 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 10135-600 TABLET 8 mg ORAL NDA 18 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 61894-010 TABLET 3.50 mg ORAL NDA 18 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 61894-011 TABLET 7 mg ORAL NDA 18 sections
Prestalia HUMAN PRESCRIPTION DRUG LABEL 2 61894-012 TABLET 14 mg ORAL NDA 18 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 65862-286 TABLET 2 mg ORAL ANDA 2 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 65862-287 TABLET 4 mg ORAL ANDA 2 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 65862-288 TABLET 8 mg ORAL ANDA 2 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-235 TABLET 2 mg ORAL ANDA 12 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-236 TABLET 4 mg ORAL ANDA 12 sections
Perindopril Erbumine HUMAN PRESCRIPTION DRUG LABEL 1 68180-237 TABLET 8 mg ORAL ANDA 12 sections
Aceon HUMAN PRESCRIPTION DRUG LABEL 1 76234-002 TABLET 8 mg ORAL NDA 19 sections