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

Stem definition	Drug id	CAS RN
atropine derivatives	333	86-13-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cogentin benztropine mesilate benzatropine benztropine tropine benzohydryl ether benztropine mesylate	A centrally active muscarinic antagonist that has been used in the symptomatic treatment of PARKINSON DISEASE. Benztropine also inhibits the uptake of dopamine. Molecular weight: 307.44 Formula: C21H25NO CLOGP: 3.52 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 12.47 ALOGS: -5.41 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cogentin
benztropine mesilate
benzatropine
benztropine
tropine benzohydryl ether
benztropine mesylate

A centrally active muscarinic antagonist that has been used in the symptomatic treatment of PARKINSON DISEASE. Benztropine also inhibits the uptake of dopamine.

Molecular weight: 307.44
Formula: C21H25NO
CLOGP: 3.52
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 12.47
ALOGS: -5.41
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	mg	O
2	mg	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	29 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.21 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
March 5, 1954	FDA

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
Completed suicide	401.57	20.67	242	7831	145431	63335518
Toxicity to various agents	172.22	20.67	183	7890	247067	63233882
Psychotic disorder	151.10	20.67	71	8002	25641	63455308
Tardive dyskinesia	146.78	20.67	51	8022	8451	63472498
Granulocytopenia	146.00	20.67	46	8027	5626	63475323
Schizophrenia	142.65	20.67	52	8021	9900	63471049
Hallucination, auditory	96.18	20.67	42	8031	12782	63468167
Oculogyric crisis	88.99	20.67	24	8049	1697	63479252
Neuroleptic malignant syndrome	88.84	20.67	39	8034	12017	63468932
Paranoia	80.33	20.67	36	8037	11643	63469306

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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
Completed suicide	247.31	20.48	211	9628	97957	34849135
Granulocytopenia	201.16	20.48	74	9765	6493	34940599
Myocarditis	182.21	20.48	85	9754	13597	34933495
Toxicity to various agents	148.42	20.48	228	9611	200134	34746958
Tardive dyskinesia	147.40	20.48	57	9782	5733	34941359
Neuroleptic malignant syndrome	127.30	20.48	73	9766	17861	34929231
Cogwheel rigidity	110.25	20.48	32	9807	1320	34945772
Schizophrenia	106.61	20.48	51	9788	8615	34938477
Extrapyramidal disorder	101.06	20.48	56	9783	12824	34934268
Dystonia	92.97	20.48	50	9789	10795	34936297

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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
Completed suicide	663.36	19.39	466	14518	245301	79484103
Granulocytopenia	357.33	19.39	118	14866	11313	79718091
Toxicity to various agents	299.73	19.39	381	14603	421159	79308245
Tardive dyskinesia	263.13	19.39	92	14892	10479	79718925
Myocarditis	214.64	19.39	97	14887	21636	79707768
Neuroleptic malignant syndrome	198.59	19.39	99	14885	27460	79701944
Schizophrenia	185.14	19.39	79	14905	15361	79714043
Psychotic disorder	171.16	19.39	103	14881	41299	79688105
Agitation	133.25	19.39	126	14858	99589	79629815
Hallucination, auditory	130.61	19.39	68	14916	20625	79708779

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N04AC01	NERVOUS SYSTEM ANTI-PARKINSON DRUGS ANTICHOLINERGIC AGENTS Ethers of tropine or tropine derivatives
CHEBI has role	CHEBI:48407	antiparkinson agent
CHEBI has role	CHEBI:48876	muscarinic antagonists
CHEBI has role	CHEBI:50370	parasympatholytics
CHEBI has role	CHEBI:66956	antidyskinetic agent
CHEBI has role	CHEBI:146270	oneirogens
CHEBI has role	CHEBI:149553	anticoronaviral drug
FDA EPC	N0000175574	Anticholinergic
FDA EPC	N0000175750	Antihistamine
FDA MoA	N0000000207	Histamine Receptor Antagonists

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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
Postencephalitic parkinsonism	indication	19972008	DOID:14332
Parkinsonism	indication	32798002
Parkinson's disease	indication	49049000	DOID:14330
Extrapyramidal disease	indication	76349003
Arteriosclerotic Parkinsonism	indication
Urinary tract obstruction	contraindication	7163005	DOID:5200
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Severe chronic ulcerative colitis	contraindication	14311001
Disorder of autonomic nervous system	contraindication	15241006
Toxic megacolon	contraindication	28536002	DOID:1770

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.86	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
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN	ANTAGONIST	Ki	9.64	WOMBAT-PK	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	6.69	DRUG MATRIX
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	7.23	DRUG MATRIX
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		IC50	4.62	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.86	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.90	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	7.50	DRUG MATRIX
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	5.89	DRUG MATRIX
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	7.52	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.65	DRUG MATRIX

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External reference:

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ID	Source
CXQ	PDB_CHEM_ID
001647	NDDF
004667	NDDF
1201549	PUBCHEM_CID
132-17-2	SECONDARY_CAS_RN
1424	RXNORM
1NHL2J4X8K	UNII
292	INN_ID
29527005	SNOMEDCT_US
3130	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9233	INJECTION	1 mg	INTRAMUSCULAR	ANDA	15 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9729	INJECTION	1 mg	INTRAMUSCULAR	ANDA	14 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9729	INJECTION	1 mg	INTRAMUSCULAR	ANDA	14 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2433	TABLET	0.50 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2434	TABLET	1 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2435	TABLET	2 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2437	TABLET	0.50 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2437	TABLET	0.50 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2437	TABLET	0.50 mg	ORAL	ANDA	16 sections
Benztropine Mesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0603-2438	TABLET	1 mg	ORAL	ANDA	16 sections

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