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

Stem definition	Drug id	CAS RN
atropine derivatives	260	51-55-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: atropine (+/-)-Atropine atropin atropinum sulphuricum DL-Hyoscyamine tropine tropate atropine sulfate	An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine. Molecular weight: 289.38 Formula: C17H23NO3 CLOGP: 1.30 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 49.77 ALOGS: -2.06 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

atropine
(+/-)-Atropine
atropin
atropinum sulphuricum
DL-Hyoscyamine
tropine tropate
atropine sulfate

An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.

Molecular weight: 289.38
Formula: C17H23NO3
CLOGP: 1.30
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 49.77
ALOGS: -2.06
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.50	mg	O
1.50	mg	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	7.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	57 %	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	4.10 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	3.30 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	139 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.61 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.03 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Sept. 15, 1960	FDA	GD SEARLE LLC

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
Stress cardiomyopathy	163.74	12.03	73	19908	9377	63459664
Macular degeneration	139.45	12.03	90	19891	24286	63444755
Death	137.25	12.03	338	19643	374043	63094998
Therapy interrupted	118.40	12.03	91	19890	32364	63436677
Bradycardia	89.91	12.03	113	19868	73114	63395927
Joint swelling	86.37	12.03	4	19977	327662	63141379
Hypotension	86.13	12.03	233	19748	272371	63196670
Therapy cessation	71.01	12.03	66	19915	30391	63438650
Cardiac arrest	70.87	12.03	114	19867	92431	63376610
Dehydration	70.26	12.03	163	19818	173191	63295850

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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
Death	93.69	12.49	417	16917	397632	34541965
Anticholinergic syndrome	60.41	12.49	23	17311	1246	34938351
Cardiac arrest	58.72	12.49	140	17194	96019	34843578
Diarrhoea	57.94	12.49	360	16974	389552	34550045
Hyperthermia malignant	57.82	12.49	26	17308	2151	34937446
Bradycardia	54.03	12.49	117	17217	75301	34864296
Therapy interrupted	50.76	12.49	47	17287	13650	34925947
Dehydration	45.71	12.49	155	17179	129814	34809783
Tachycardia	43.94	12.49	116	17218	84656	34854941
Pulse absent	40.90	12.49	29	17305	5774	34933823

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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
Therapy interrupted	200.46	12.06	133	30076	31208	79682971
Death	185.05	12.06	551	29658	565963	79148216
Stress cardiomyopathy	183.44	12.06	88	30121	11078	79703101
Cardiac arrest	129.43	12.06	233	29976	171863	79542316
Bradycardia	122.28	12.06	199	30010	135358	79578821
Therapy cessation	117.23	12.06	104	30105	37458	79676721
Anticholinergic syndrome	93.05	12.06	39	30170	3572	79710607
Hypotension	86.71	12.06	363	29846	439954	79274225
Hyperthermia malignant	83.62	12.06	34	30175	2883	79711296
Arthralgia	73.75	12.06	65	30144	571738	79142441

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A03BA01	ALIMENTARY TRACT AND METABOLISM DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS BELLADONNA AND DERIVATIVES, PLAIN Belladonna alkaloids, tertiary amines
ATC	A03CB03	ALIMENTARY TRACT AND METABOLISM DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS Belladonna and derivatives in combination with psycholeptics
ATC	S01FA01	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Anticholinergics
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:38070	antiarrhythmic agent
CHEBI has role	CHEBI:48876	muscarinic antagonists
CHEBI has role	CHEBI:50370	parasympatholytics
CHEBI has role	CHEBI:50513	mydriatics
CHEBI has role	CHEBI:60807	anaesthestic adjuvant
CHEBI has role	CHEBI:76924	plant metabolites

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

Disease	Relation	SNOMED_ID	DOID
Perioperative Mydriasis	indication

🐶 Veterinary Drug Use

Species	Use	Relation
Rodents	Treatment of Syphacia obvelata (pinworm)	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Dyrex Powder	Zoetis Inc.	2
Freed No. 10, Freed No. 25	Zoetis Inc.	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.24	acidic
pKa2	9.26	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.4MG/ML (0.4MG/ML)	ATROPINE SULFATE	AM REGENT	A216120	May 26, 2022	RX	SOLUTION	INTRAVENOUS	Jan. 29, 2023	COMPETITIVE GENERIC THERAPY
1MG/ML (1MG/ML)	ATROPINE SULFATE	AM REGENT	A216120	May 26, 2022	RX	SOLUTION	INTRAVENOUS	Jan. 29, 2023	COMPETITIVE GENERIC THERAPY

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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	9.31	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN	ANTAGONIST	Ki	8.97	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	9.50	WOMBAT-PK	CHEMBL
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	5.91	PDSP
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	9.39	WOMBAT-PK
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	9.29	WOMBAT-PK
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	6.18	DRUG MATRIX
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.91	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	ANTAGONIST	Ki	4.85	IUPHAR
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	5.16	PDSP

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External reference:

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ID	Source
OIN	PDB_CHEM_ID
001715	NDDF
001717	NDDF
1223	RXNORM
174174	PUBCHEM_CID
27333	MMSL
320	IUPHAR_LIGAND_ID
372832002	SNOMEDCT_US
4017410	VANDF
4019591	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
atropine sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0817	SOLUTION	10 mg	OPHTHALMIC	NDA	25 sections
atropine sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0817	SOLUTION	10 mg	OPHTHALMIC	NDA	25 sections
ATROPINE SULFATE	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9819	INJECTION, SOLUTION	1 mg	INTRAVENOUS	unapproved drug other	11 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9820	INJECTION, SOLUTION	0.40 mg	INTRAMUSCULAR	unapproved drug other	10 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9821	INJECTION, SOLUTION	0.10 mg	INTRAVENOUS	unapproved drug other	13 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9821	INJECTION, SOLUTION	0.10 mg	INTRAVENOUS	unapproved drug other	13 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9822	INJECTION, SOLUTION	0.10 mg	INTRAMUSCULAR	unapproved drug other	14 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9822	INJECTION, SOLUTION	0.10 mg	INTRAMUSCULAR	unapproved drug other	14 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9823	INJECTION, SOLUTION	0.05 mg	INTRAMUSCULAR	NDA	15 sections
Atropine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9823	INJECTION, SOLUTION	0.05 mg	INTRAMUSCULAR	NDA	15 sections

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