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

Stem definition	Drug id	CAS RN
local anaesthetics	3016	99-43-4

Description:

Molecule

Description

Molfile Inchi Smiles

Synonyms:

benoxinate
benoxinate hydrochloride
oxybucaine
oxybuprocaine
benoxinate HCl

Molecular weight: 308.42
Formula: C17H28N2O3
CLOGP: 4.36
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 64.79
ALOGS: -2.75
ROTB: 11

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 9, 2020	FDA	BAUSCH

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	167.69	114.70	21	84	1750	63487167

FDA Adverse Event Reporting System (Male)

None

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	176.24	84.76	24	153	2740	79741471
Aqueous fibrin	126.02	84.76	13	164	125	79744086

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D04AB03	DERMATOLOGICALS ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. Anesthetics for topical use
ATC	S01HA02	SENSORY ORGANS OPHTHALMOLOGICALS LOCAL ANESTHETICS Local anesthetics
MeSH PA	D000777	Anesthetics
MeSH PA	D000779	Anesthetics, Local
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
CHEBI has role	CHEBI:36333	local anesthetics
CHEBI has role	CHEBI:48425	topical anesthetic
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Topical local anesthetic to eye	indication	231346001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.8	Basic
pKa2	2.87	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10293047	Nov. 15, 2037	OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10632197	Nov. 15, 2037	OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC
0.4%;0.3%	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	BAUSCH LOMB IRELAND	N211039	March 9, 2020	RX	SOLUTION/DROPS	OPHTHALMIC	10842872	Nov. 15, 2037	PROCEDURES IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC.

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium channel protein type 10 subunit alpha	Ion channel	Q9Y5Y9	SCNAA_HUMAN	BLOCKER				DRUGBANK	CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel	P35498 Q99250 Q9NY46	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN	BLOCKER	IC50	5.54		CHEMBL	CHEMBL

External reference:

ID	Source
4019627	VUID
N0000179047	NUI
D08319	KEGG_DRUG
5987-82-6	SECONDARY_CAS_RN
4018751	VANDF
4019627	VANDF
CHEBI:309594	CHEBI
CHEMBL1200	ChEMBL_ID
CHEMBL1200654	ChEMBL_ID
C005298	MESH_SUPPLEMENTAL_RECORD_UI
7123	IUPHAR_LIGAND_ID
DB00892	DRUGBANK_ID
18889	RXNORM
4253	MMSL
001355	NDDF
004569	NDDF
370315001	SNOMEDCT_US
387063004	SNOMEDCT_US
52140009	SNOMEDCT_US
C0053114	UMLSCUI
275	INN_ID
4633	PUBCHEM_CID
AXQ0JYM303	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FLURESS	HUMAN PRESCRIPTION DRUG LABEL	2	17478-640	SOLUTION/ DROPS	4 mg	OPHTHALMIC	unapproved drug other	15 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	24208-734	SOLUTION/ DROPS	4.40 mg	OPHTHALMIC	NDA	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	24208-734	SOLUTION/ DROPS	4.40 mg	OPHTHALMIC	NDA	21 sections
Flurox	HUMAN PRESCRIPTION DRUG LABEL	2	54799-508	SOLUTION	4 mg	OPHTHALMIC	unapproved drug other	12 sections
ALTAFLUOR	HUMAN PRESCRIPTION DRUG LABEL	2	59390-218	SOLUTION	4 mg	OPHTHALMIC	NDA	21 sections
ALTAFLUOR	HUMAN PRESCRIPTION DRUG LABEL	2	59390-218	SOLUTION	4 mg	OPHTHALMIC	NDA	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	68682-732	SOLUTION/ DROPS	4.40 mg	OPHTHALMIC	NDA authorized generic	21 sections
Fluorescein Sodium and Benoxinate Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	82260-734	SOLUTION/ DROPS	4.40 mg	OPHTHALMIC	NDA authorized generic	21 sections