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

Stem definition	Drug id	CAS RN
atropine derivatives	2774	1508-75-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tropicamide bistropamide epitromina mydriacyl	One of the MUSCARINIC ANTAGONISTS with pharmacologic action similar to ATROPINE and used mainly as an ophthalmic parasympatholytic or mydriatic. Molecular weight: 284.36 Formula: C17H20N2O2 CLOGP: 1.18 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 53.43 ALOGS: -2.88 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tropicamide
bistropamide
epitromina
mydriacyl

One of the MUSCARINIC ANTAGONISTS with pharmacologic action similar to ATROPINE and used mainly as an ophthalmic parasympatholytic or mydriatic.

Molecular weight: 284.36
Formula: C17H20N2O2
CLOGP: 1.18
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 53.43
ALOGS: -2.88
ROTB: 6

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Feb. 23, 1960	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
Toxic anterior segment syndrome	201.87	41.91	36	1727	1735	63485524
Macular oedema	139.26	41.91	30	1733	3847	63483412
Visual acuity reduced	120.26	41.91	38	1725	21788	63465471
Vision blurred	111.04	41.91	53	1710	91871	63395388
Cataract nuclear	106.65	41.91	19	1744	906	63486353
Vitreous floaters	100.76	41.91	25	1738	5941	63481318
Corneal oedema	97.57	41.91	19	1744	1474	63485785
Endophthalmitis	96.95	41.91	22	1741	3570	63483689
Retinal haemorrhage	94.96	41.91	23	1740	4946	63482313
Cystoid macular oedema	84.49	41.91	17	1746	1558	63485701

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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
Toxic anterior segment syndrome	181.00	41.44	32	1216	1137	34954546
Vitreous floaters	107.25	41.44	25	1223	3560	34952123
Visual acuity reduced	105.65	41.44	34	1214	16115	34939568
Vision blurred	77.30	41.44	36	1212	45927	34909756
Blindness	60.48	41.44	22	1226	14964	34940719
Endophthalmitis	52.24	41.44	14	1234	3494	34952189
Retinal haemorrhage	51.47	41.44	15	1233	5074	34950609
Floppy iris syndrome	51.15	41.44	9	1239	308	34955375
Corneal oedema	48.82	41.44	11	1237	1340	34954343
Cataract nuclear	46.40	41.44	9	1239	529	34955154

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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
Toxic anterior segment syndrome	372.75	32.28	66	2440	2698	79739184
Visual acuity reduced	171.14	32.28	55	2451	29414	79712468
Corneal oedema	135.46	32.28	28	2478	2592	79739290
Vision blurred	120.42	32.28	61	2445	105837	79636045
Endophthalmitis	120.40	32.28	30	2476	6398	79735484
Vitreous floaters	102.27	32.28	27	2479	7229	79734653
Macular oedema	99.77	32.28	25	2481	5449	79736433
Blindness	87.26	32.28	33	2473	28350	79713532
Eye inflammation	76.86	32.28	21	2485	6392	79735490
Retinal haemorrhage	71.71	32.28	21	2485	8196	79733686

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	S01FA06	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Anticholinergics
ATC	S01FA56	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Anticholinergics
FDA EPC	N0000175574	Anticholinergic
FDA MoA	N0000175370	Cholinergic Antagonists
MeSH PA	D018678	Cholinergic Agents
MeSH PA	D018680	Cholinergic Antagonists
MeSH PA	D018727	Muscarinic Antagonists
MeSH PA	D009184	Mydriatics
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System 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
Dilated pupil	indication	37125009
Cycloplegia	indication	68158006	DOID:10033
Perioperative Mydriasis	indication
Ocular hypertension	contraindication	4210003	DOID:9282
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Conduction disorder of the heart	contraindication	44808001
Diabetes mellitus	contraindication	73211009	DOID:9351
Open-angle glaucoma	contraindication	84494001	DOID:1067
Shallow anterior chamber of eye	contraindication	246986004

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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	5.35	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
2.5%;1%	MYDCOMBI	EYENOVIA	N215352	May 5, 2023	RX	SPRAY, METERED	OPHTHALMIC	May 5, 2026	NEW PRODUCT

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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 M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	7.52	DRUG MATRIX	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	7.43	DRUG MATRIX
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	7.17	DRUG MATRIX
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	7.19	DRUG MATRIX
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	6	DRUG MATRIX
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6	DRUG MATRIX
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	8.46	PDSP

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External reference:

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ID	Source
001726	NDDF
1059	INN_ID
10869	RXNORM
1997	MMSL
3084	MMSL
387526001	SNOMEDCT_US
4018592	VUID
4018592	VANDF
5593	PUBCHEM_CID
5645	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
MYDCOMBI	HUMAN PRESCRIPTION DRUG LABEL	2	81046-0111	SPRAY, METERED	0.08 mg	OPHTHALMIC	NDA	24 sections
Mydriacyl	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	19 sections
Mydriacyl	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	19 sections
Mydriacyl	HUMAN PRESCRIPTION DRUG LABEL	1	0998-0355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	19 sections
Mydriacyl	HUMAN PRESCRIPTION DRUG LABEL	1	0998-0355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	19 sections
Mydriatic-4	HUMAN PRESCRIPTION DRUG LABEL	4	71384-632	SOLUTION/ DROPS	10 mg	OPHTHALMIC	unapproved drug other	2 sections
Paremyd	HUMAN PRESCRIPTION DRUG LABEL	2	17478-704	SOLUTION	2.50 mg	OPHTHALMIC	NDA	21 sections
Paremyd	HUMAN PRESCRIPTION DRUG LABEL	2	17478-704	SOLUTION	2.50 mg	OPHTHALMIC	NDA	21 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	0404-7192	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-101	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	18 sections

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