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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)

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
Eye inflammation	67.78	41.91	18	1745	5581	63481678
Visual impairment	64.99	41.91	36	1727	84410	63402849
Therapeutic product effect prolonged	59.15	41.91	10	1753	349	63486910
Hypopyon	58.29	41.91	11	1752	721	63486538
Eye pain	58.12	41.91	25	1738	33829	63453430
Choroidal neovascularisation	53.35	41.91	9	1754	310	63486949
Metamorphopsia	53.21	41.91	11	1752	1152	63486107
Vitreous detachment	52.44	41.91	12	1751	2015	63485244
Detachment of retinal pigment epithelium	51.40	41.91	9	1754	387	63486872
Retinal disorder	49.11	41.91	11	1752	1679	63485580
Cataract	48.50	41.91	26	1737	57027	63430232
Eye irritation	47.04	41.91	19	1744	21952	63465307
Floppy iris syndrome	46.45	41.91	7	1756	115	63487144
Multiple use of single-use product	44.93	41.91	10	1753	1482	63485777
Macular fibrosis	44.87	41.91	8	1755	382	63486877
Conjunctival ulcer	44.61	41.91	6	1757	41	63487218
Intraocular pressure increased	43.69	41.91	13	1750	6065	63481194
Vitritis	43.15	41.91	9	1754	983	63486276
Monocytosis	41.95	41.91	8	1755	554	63486705

FDA Adverse Event Reporting System (Male)

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
Cataract	45.45	41.44	21	1227	26165	34929518
Macular oedema	45.14	41.44	12	1236	2902	34952781
Visual impairment	44.94	41.44	23	1225	35779	34919904

FDA Adverse Event Reporting System (Geriatric)

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
Cataract nuclear	70.83	32.28	14	2492	1032	79740850
Eye pain	65.17	32.28	29	2477	37549	79704333
Intraocular pressure increased	65.09	32.28	20	2486	9185	79732697
Hypopyon	63.67	32.28	13	2493	1129	79740753
Vitritis	63.30	32.28	14	2492	1780	79740102
Retinal disorder	61.46	32.28	14	2492	2033	79739849
Visual impairment	60.40	32.28	37	2469	92094	79649788
Cataract	59.63	32.28	32	2474	62088	79679794
Cystoid macular oedema	51.23	32.28	12	2494	1968	79739914
Choroidal neovascularisation	48.67	32.28	9	2497	465	79741417
Multiple use of single-use product	48.47	32.28	10	2496	914	79740968
Angle closure glaucoma	46.38	32.28	12	2494	2964	79738918
Eye irritation	45.85	32.28	19	2487	20662	79721220
Macular fibrosis	44.87	32.28	9	2497	714	79741168
Detachment of retinal pigment epithelium	43.79	32.28	9	2497	807	79741075
Anterior chamber cell	42.43	32.28	9	2497	940	79740942
Ophthalmological examination abnormal	41.48	32.28	6	2500	64	79741818
Metamorphopsia	39.66	32.28	9	2497	1284	79740598
Vitreous detachment	39.57	32.28	10	2496	2249	79739633
Ocular hyperaemia	37.14	32.28	18	2488	28188	79713694
Retinal scar	36.81	32.28	7	2499	421	79741461
Monocytosis	36.17	32.28	8	2498	1016	79740866
Anterior chamber fibrin	35.95	32.28	6	2500	170	79741712
Ulcerative keratitis	34.71	32.28	10	2496	3679	79738203
Therapeutic product effect prolonged	34.70	32.28	7	2499	572	79741310
Retinal aneurysm	33.21	32.28	6	2500	272	79741610

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	S01FA06	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Anticholinergics
ATC	S01FA56	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Anticholinergics
FDA MoA	N0000175370	Cholinergic Antagonists
FDA EPC	N0000175574	Anticholinergic
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

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

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
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Myocardial ischemia	contraindication	414795007	DOID:3393
Primary Closed Angle Glaucoma	contraindication

🐶 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)

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

Bioactivity Summary:

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

External reference:

ID	Source
4018592	VUID
N0000146908	NUI
D00397	KEGG_DRUG
4018592	VANDF
C0041190	UMLSCUI
CHEBI:9757	CHEBI
CHEMBL1200604	ChEMBL_ID
DB00809	DRUGBANK_ID
D014331	MESH_DESCRIPTOR_UI
5593	PUBCHEM_CID
7319	IUPHAR_LIGAND_ID
1059	INN_ID
N0A3Z5XTC6	UNII
10869	RXNORM
1997	MMSL
3084	MMSL
5645	MMSL
001726	NDDF
387526001	SNOMEDCT_US
9190005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	0404-7192	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	18 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
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-101	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-101	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-101	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-102	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-102	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	18 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	17478-102	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	18 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	24208-585	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	17 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	24208-590	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	17 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	61314-354	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	19 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	61314-354	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	19 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	61314-355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	11 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	61314-355	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	11 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	70069-121	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	16 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	70069-121	SOLUTION/ DROPS	10 mg	OPHTHALMIC	ANDA	16 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	70518-2759	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	19 sections
Tropicamide	HUMAN PRESCRIPTION DRUG LABEL	1	70518-2759	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	19 sections
Mydriatic-4	HUMAN PRESCRIPTION DRUG LABEL	4	71384-632	SOLUTION/ DROPS	10 mg	OPHTHALMIC	unapproved drug other	2 sections
MYDCOMBI	HUMAN PRESCRIPTION DRUG LABEL	2	81046-0111	SPRAY, METERED	0.08 mg	OPHTHALMIC	NDA	24 sections