benazepril 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
angiotensin-converting enzyme inhibitors	299	86541-75-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: benazepril cibacen benazepril hydrochloride benazepril HCl	prodrug of benazeprilat inhibit angiotensin-converting enzyme (ACE) and results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion Molecular weight: 424.50 Formula: C24H28N2O5 CLOGP: 1.82 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 95.94 ALOGS: -4.61 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

benazepril
cibacen
benazepril hydrochloride
benazepril HCl

prodrug of benazeprilat inhibit angiotensin-converting enzyme (ACE) and results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion

Molecular weight: 424.50
Formula: C24H28N2O5
CLOGP: 1.82
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 95.94
ALOGS: -4.61
ROTB: 10

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
7.50	mg	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	78 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	3.13 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	18 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
June 25, 1991	FDA	US PHARMS HOLDINGS I

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Angioedema	137.02	12.83	111	17686	47854	63423371
Cerebrovascular accident	127.18	12.83	154	17643	107870	63363355
Coronary artery disease	116.63	12.83	86	17711	32291	63438934
Myocardial infarction	115.29	12.83	141	17656	99752	63371473
Cardiac failure congestive	109.14	12.83	132	17665	92301	63378924
Off label use	69.18	12.83	53	17744	674409	62796816
Drug ineffective	55.61	12.83	133	17664	1044632	62426593
Maternal exposure during pregnancy	44.21	12.83	5	17792	220057	63251168
Contraindicated product administered	43.59	12.83	5	17792	217643	63253582
Transient ischaemic attack	43.02	12.83	53	17744	37700	63433525

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Angioedema	197.49	13.20	145	14110	37229	34905447
Myocardial infarction	127.14	13.20	198	14057	120887	34821789
Coronary artery disease	107.93	13.20	115	14140	48190	34894486
Cardiac failure congestive	73.47	13.20	126	14129	83144	34859532
Cerebrovascular accident	70.49	13.20	125	14130	84686	34857990
Off label use	63.90	13.20	47	14208	419477	34523199
Oropharyngeal oedema	34.28	13.20	8	14247	92	34942584
Injury	33.89	13.20	42	14213	20645	34922031
Shock	31.71	13.20	44	14211	24135	34918541
Distributive shock	29.58	13.20	13	14242	1241	34941435

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Angioedema	287.48	12.01	218	24988	75817	79643365
Myocardial infarction	252.99	12.01	301	24905	183828	79535354
Coronary artery disease	243.67	12.01	186	25020	65288	79653894
Cerebrovascular accident	192.31	12.01	241	24965	155051	79564131
Cardiac failure congestive	159.00	12.01	210	24996	142192	79576990
Off label use	112.07	12.01	75	25131	907140	78812042
Chest pain	52.53	12.01	202	25004	282102	79437080
Transient ischaemic attack	51.59	12.01	73	25133	52622	79666560
Emotional distress	50.91	12.01	63	25143	39906	79679276
Angina unstable	50.80	12.01	42	25164	16485	79702697

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C09AA07	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, PLAIN ACE inhibitors, plain
ATC	C09BA07	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors and diuretics
ATC	C09BB13	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors and calcium channel blockers
CHEBI has role	CHEBI:35457	ACE inhibitor
CHEBI has role	CHEBI:50266	Prodrugs
FDA EPC	N0000175562	Angiotensin Converting Enzyme Inhibitor
FDA MoA	N0000000181	Angiotensin-converting Enzyme Inhibitors
FDA PE	N0000178477	Decreased Blood Pressure
MeSH PA	D000806	Angiotensin-Converting Enzyme Inhibitors
MeSH PA	D000959	Antihypertensive Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Chronic heart failure	off-label use	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diabetic renal disease	off-label use	127013003
Acute scleroderma renal crisis	off-label use	236503001
Diastolic heart failure	off-label use	418304008	DOID:9775
Hypertension due to Scleroderma	off-label use
Nondiabetic Proteinuric Nephropathy	off-label use
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

Product	Applicant	Ingredients
Cardalis	Ceva Sante Animale	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.9	acidic
pKa2	5.34	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Angiotensin-converting enzyme	Enzyme	P12821	ACE_HUMAN	INHIBITOR	IC50	6.51	WOMBAT-PK	CHEMBL
Angiotensin-converting enzyme	Enzyme		ACE_RABIT		IC50	8.70	CHEMBL
Angiotensin-converting enzyme	Enzyme		ACE_RAT		IC50	8.77	CHEMBL

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External reference:

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ID	Source
003597	NDDF
003598	NDDF
108572003	SNOMEDCT_US
108573008	SNOMEDCT_US
1267	MMSL
1546196	RXNORM
372511001	SNOMEDCT_US
4020025	VANDF
4020817	VUID
4020817	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0211	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0211	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0211	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0211	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0236	TABLET, FILM COATED	5 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0236	TABLET, FILM COATED	5 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0236	TABLET, FILM COATED	5 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0236	TABLET, FILM COATED	5 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0277	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections
Benazepril Hydrochloride and Hydrochlorothiazide	HUMAN PRESCRIPTION DRUG LABEL	2	0185-0277	TABLET, FILM COATED	20 mg	ORAL	ANDA	22 sections

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