tropicamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
atropine derivatives 2774 1508-75-4

Description:

MoleculeDescription

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,JAK1,JAK2,MAP3K21,MAP3K7,MAPK12,MAPK7,MAPK9,MARK4,NTRK2,PDK2,PDK4,PIK3CB,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK 38
kinase-selectivity-class AXL,BRAF,CDK9,ERBB2,GRK2,MAP2K6 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Feb. 23, 1960 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxic anterior segment syndrome 213.84 41.42 39 2386 2211 90623811
Macular oedema 133.25 41.42 30 2395 4879 90621143
Visual acuity reduced 131.40 41.42 41 2384 23369 90602653
Eye inflammation 119.24 41.42 30 2395 7821 90618201
Endophthalmitis 112.97 41.42 26 2399 4659 90621363
Monocytosis 112.56 41.42 20 2405 974 90625048
Vision blurred 109.40 41.42 55 2370 110238 90515784
Cataract nuclear 104.14 41.42 19 2406 1075 90624947
Retinal haemorrhage 102.49 41.42 25 2400 5739 90620283
Eye pain 98.84 41.42 39 2386 44129 90581893
Vitreous floaters 95.79 41.42 25 2400 7524 90618498
Corneal oedema 93.66 41.42 19 2406 1882 90624140
Ulcerative keratitis 93.13 41.42 21 2404 3432 90622590
Conjunctival hyperaemia 89.43 41.42 20 2405 3149 90622873
Exposure to SARS-CoV-2 88.84 41.42 19 2406 2433 90623589
Cystoid macular oedema 80.22 41.42 17 2408 2083 90623939
SARS-CoV-2 test positive 64.52 41.42 20 2405 11108 90614914
Ocular hyperaemia 62.36 41.42 26 2399 33772 90592250
Visual impairment 58.36 41.42 39 2386 132326 90493696
Therapeutic product effect prolonged 58.09 41.42 10 2415 404 90625618
Hypopyon 56.25 41.42 11 2414 903 90625119
Necrotising colitis 52.07 41.42 11 2414 1327 90624695
Choroidal neovascularisation 51.48 41.42 9 2416 398 90625624
Metamorphopsia 51.13 41.42 11 2414 1446 90624576
Vitreous detachment 50.97 41.42 12 2413 2366 90623656
Intraocular pressure increased 50.78 41.42 15 2410 7078 90618944
Detachment of retinal pigment epithelium 49.54 41.42 9 2416 496 90625526
Retinal disorder 48.11 41.42 11 2414 1908 90624114
Floppy iris syndrome 46.71 41.42 7 2418 115 90625907
Cataract 46.31 41.42 27 2398 72065 90553957
Anterior chamber cell 46.16 41.42 9 2416 727 90625295
Anterior chamber fibrin 45.95 41.42 7 2418 129 90625893
Macular fibrosis 44.90 41.42 8 2417 395 90625627
Vitritis 44.51 41.42 10 2415 1604 90624418
Conjunctival ulcer 44.46 41.42 6 2419 44 90625978
Multiple use of single-use product 43.30 41.42 10 2415 1813 90624209
Periumbilical abscess 42.36 41.42 7 2418 220 90625802
Catheter site abscess 41.55 41.42 7 2418 248 90625774

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxic anterior segment syndrome 180.87 38.79 33 1508 1383 42618411
Visual acuity reduced 122.74 38.79 39 1502 17511 42602283
Vitreous floaters 102.77 38.79 25 1516 4205 42615589
Blindness 74.50 38.79 27 1514 17951 42601843
Vision blurred 74.40 38.79 37 1504 53662 42566132
Floppy iris syndrome 57.54 38.79 10 1531 314 42619480
Eye pain 57.44 38.79 22 1519 17008 42602786
Endophthalmitis 53.32 38.79 15 1526 4418 42615376
Corneal oedema 52.52 38.79 12 1529 1536 42618258
Retinal haemorrhage 49.41 38.79 15 1526 5755 42614039
Anterior chamber cell 47.53 38.79 9 1532 459 42619335
Visual impairment 46.11 38.79 25 1516 43088 42576706
Cataract 45.03 38.79 22 1519 30582 42589212
Cataract nuclear 42.75 38.79 9 1532 788 42619006
Macular oedema 42.57 38.79 12 1529 3557 42616237

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxic anterior segment syndrome 386.46 33.17 70 3270 3384 110582575
Visual acuity reduced 201.38 33.17 63 3277 32110 110553849
Endophthalmitis 133.82 33.17 34 3306 8153 110577806
Corneal oedema 131.18 33.17 28 3312 3145 110582814
Eye inflammation 129.99 33.17 34 3306 9137 110576822
Vision blurred 113.96 33.17 62 3278 128960 110456999
Eye pain 102.70 33.17 43 3297 50056 110535903
Blindness 101.54 33.17 39 3301 36320 110549639
Monocytosis 98.95 33.17 20 3320 1720 110584239
Vitreous floaters 97.14 33.17 27 3313 9107 110576852
Macular oedema 94.75 33.17 25 3315 6941 110579018
Anterior chamber cell 93.52 33.17 18 3322 1203 110584756
Ulcerative keratitis 88.86 33.17 22 3318 4744 110581215
Exposure to SARS-CoV-2 83.23 33.17 19 3321 2900 110583059
Retinal haemorrhage 78.20 33.17 23 3317 9478 110576481
Intraocular pressure increased 70.89 33.17 22 3318 10854 110575105
Cataract nuclear 67.25 33.17 14 3326 1392 110584567
Conjunctival hyperaemia 65.51 33.17 18 3322 5813 110580146
Vitritis 63.60 33.17 15 3325 2638 110583321
Cataract 61.35 33.17 35 3305 79450 110506509
Hypopyon 61.17 33.17 13 3327 1427 110584532
Visual impairment 60.41 33.17 42 3298 134386 110451573
Retinal disorder 59.97 33.17 14 3326 2356 110583603
Anterior chamber fibrin 54.77 33.17 9 3331 241 110585718
SARS-CoV-2 test positive 53.89 33.17 20 3320 16915 110569044
Cystoid macular oedema 52.57 33.17 13 3327 2787 110583172
Angle closure glaucoma 49.69 33.17 13 3327 3486 110582473
Choroidal neovascularisation 47.54 33.17 9 3331 550 110585409
Multiple use of single-use product 45.49 33.17 10 3330 1286 110584673
Macular fibrosis 45.21 33.17 9 3331 715 110585244
Eye disorder 43.56 33.17 20 3320 28886 110557073
Ocular hyperaemia 43.49 33.17 22 3318 39264 110546695
Vitreal cells 42.98 33.17 7 3333 177 110585782
Detachment of retinal pigment epithelium 42.27 33.17 9 3331 996 110584963
Ophthalmological examination abnormal 41.98 33.17 6 3334 61 110585898
Catheter site abscess 40.10 33.17 7 3333 271 110585688
Periumbilical abscess 39.16 33.17 7 3333 311 110585648
Uveitis 39.04 33.17 17 3323 21693 110564266
Floppy iris syndrome 38.41 33.17 7 3333 347 110585612
Vitreous detachment 38.32 33.17 10 3330 2655 110583304
Metamorphopsia 37.92 33.17 9 3331 1624 110584335
Eye irritation 37.81 33.17 19 3321 33433 110552526
Vitreous haemorrhage 37.20 33.17 11 3329 4609 110581350
Retinal scar 36.29 33.17 7 3333 472 110585487
Corneal opacity 34.89 33.17 8 3332 1243 110584716
Corneal disorder 33.78 33.17 9 3331 2588 110583371
Retinal aneurysm 33.49 33.17 6 3334 270 110585689
Therapeutic product effect prolonged 33.47 33.17 7 3333 711 110585248

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 D009184 Mydriatics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018727 Muscarinic Antagonists
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:66981 ophthalmology drug

Related Drugs by ATC class:

S01FA Anticholinergics 5 drugs

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

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 5.35 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2.5%;1% MYDCOMBI EYENOVIA N215352 May 5, 2023 DISCN SPRAY, METERED OPHTHALMIC 10839960 July 15, 2031 METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE
2.5%;1% MYDCOMBI EYENOVIA N215352 May 5, 2023 DISCN SPRAY, METERED OPHTHALMIC 11398306 July 15, 2031 METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE
2.5%;1% MYDCOMBI EYENOVIA N215352 May 5, 2023 DISCN SPRAY, METERED OPHTHALMIC 11839487 July 15, 2031 METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2.5%;1% MYDCOMBI EYENOVIA N215352 May 5, 2023 DISCN SPRAY, METERED OPHTHALMIC May 5, 2026 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 7.52 DRUG MATRIX CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 7.43 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 7.17 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 7.19 DRUG MATRIX
Cytochrome P450 2C9 Enzyme IC50 6 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 8.46 PDSP

External reference:

IDSource
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
N0A3Z5XTC6 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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
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 61314-355 SOLUTION/ DROPS 10 mg OPHTHALMIC ANDA 11 sections
Tropicamide HUMAN PRESCRIPTION DRUG LABEL 1 70069-121 SOLUTION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections
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
Tropicamide HUMAN PRESCRIPTION DRUG LABEL 1 85766-040 SOLUTION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections