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

Stem definition	Drug id	CAS RN
local anaesthetics	2610	94-24-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tetracaine monohydrochloride pontocaine tetracaine amethocaine laudocaine tetracaine hydrochloride tetracaine HCl	Local ester anesthetic that blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction. Molecular weight: 264.37 Formula: C15H24N2O2 CLOGP: 3.83 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 41.57 ALOGS: -2.68 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tetracaine monohydrochloride
pontocaine
tetracaine
amethocaine
laudocaine
tetracaine hydrochloride
tetracaine HCl

Local ester anesthetic that blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.

Molecular weight: 264.37
Formula: C15H24N2O2
CLOGP: 3.83
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 41.57
ALOGS: -2.68
ROTB: 9

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 23, 2005	FDA	GALEN SPECIALTY

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	145.85	44.82	24	715	1747	63486536
Aqueous fibrin	92.65	44.82	11	728	66	63488217
Endophthalmitis	79.37	44.82	16	723	3576	63484707
Suspected transmission of an infectious agent via product	53.89	44.82	8	731	294	63487989
Visual acuity reduced	46.58	44.82	15	724	21811	63466472

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FDA Adverse Event Reporting System (Male)

None

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	203.73	49.55	33	714	2731	79740910
Aqueous fibrin	106.92	49.55	13	734	125	79743516
Suspected transmission of an infectious agent via product	93.28	49.55	15	732	1171	79742470
Endophthalmitis	84.88	49.55	18	729	6410	79737231

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C05AD02	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Local anesthetics
ATC	D04AB06	DERMATOLOGICALS ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC. Anesthetics for topical use
ATC	N01BA03	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Esters of aminobenzoic acid
ATC	N01BA53	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, LOCAL Esters of aminobenzoic acid
ATC	S01HA03	SENSORY ORGANS OPHTHALMOLOGICALS LOCAL ANESTHETICS Local anesthetics
CHEBI has role	CHEBI:36333	local anesthetics
FDA CS	M0007766	Esters
FDA EPC	N0000175683	Ester Local Anesthetic
FDA PE	N0000175976	Local Anesthesia
MeSH PA	D000777	Anesthetics

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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
Local anesthetic intrathecal block	indication	231249005
Skin irritation	indication	367466007
Local anesthesia	indication	386761002
Itching of skin	indication	418363000
Minor Skin Wound Pain	indication
Local Anesthesia for Ophthalmologic Procedure	indication
Administration of Corneal Anesthesia	indication
Hyperthyroidism	contraindication	34486009	DOID:7998
Conduction disorder of the heart	contraindication	44808001
Disorder of cardiovascular system	contraindication	49601007	DOID:1287

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Acute otitis externa	Indication
Cats	Chronic otitis externa	Indication
Cats	Ear canker	Indication
Cats	Inflammatory conditions of the external ear canal	Indication
Cats	Dressing for minor cuts, lacerations, abrasions, and post-surgical therapy	Indication
Cats	Following amputation of dewclaw	Indication
Cats	Following amputation of tails and claws	Indication
Cats	Following ear trimming	Indication
Cats	Following castrating operations	Indication
Dogs	Acute otitis externa	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Neo-Cortef with Tetracaine	Zoetis Inc.	3
Neo-Delta-Cortef with Tetracaine Ointment	Zoetis Inc.	3
Neo-Predef with Tetracaine Powder	Zoetis Inc.	3
Neo-Predef with Tetracaine Top. Ointment, Tritop Topical Ointment	Zoetis Inc.	3

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.51	Basic
pKa2	2.67	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.1MG/SPRAY;6MG/SPRAY	KOVANAZE	ST RENATUS	N208032	June 29, 2016	RX	SPRAY, METERED	NASAL	8580282	April 2, 2030	METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
0.1MG/SPRAY;6MG/SPRAY	KOVANAZE	ST RENATUS	N208032	June 29, 2016	RX	SPRAY, METERED	NASAL	9308191	April 2, 2030	METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN	BLOCKER	IC50	6.28	CHEMBL	CHEMBL
Sodium channel protein type 2 subunit alpha	Ion channel	Q99250	SCN2A_HUMAN	BLOCKER	IC50	5.96	CHEMBL	CHEMBL
Sodium channel protein type 9 subunit alpha	Ion channel	Q15858	SCN9A_HUMAN	BLOCKER	Ki	6.30	CHEMBL	CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel	P35498 Q99250 Q9NY46	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN	BLOCKER	IC50	5.47	CHEMBL	CHEMBL
Sodium channel protein type 8 subunit alpha	Ion channel	Q9UQD0	SCN8A_HUMAN		IC50	6.28	CHEMBL
Amine oxidase [flavin-containing] A	Enzyme	P21397	AOFA_HUMAN		IC50	6.50	DRUG MATRIX
Sodium channel protein type 7 subunit alpha	Ion channel	Q01118	SCN7A_HUMAN		IC50	7.25	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	6.15	DRUG MATRIX
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	6.01	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	5.77	DRUG MATRIX

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External reference:

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ID	Source
TE4	PDB_CHEM_ID
001361	NDDF
001362	NDDF
0619F35CGV	UNII
10391	RXNORM
136-47-0	SECONDARY_CAS_RN
177214	MMSL
387309008	SNOMEDCT_US
4018254	VANDF
4019456	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Burn Cream	HUMAN OTC DRUG LABEL	1	37945-212	CREAM	10 mg	TOPICAL	OTC monograph not final	11 sections
Cetacaine Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0201	AEROSOL, SPRAY	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	12 sections
Cetacaine Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0202	SOLUTION	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	12 sections
Cetacaine Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0202	SOLUTION	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	12 sections
Cetacaine Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0225	SOLUTION	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	12 sections
Cetacaine Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0226	SOLUTION	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	12 sections
Cetacaine Topical Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0217	GEL	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	11 sections
Cetacaine Topical Anesthetic	HUMAN PRESCRIPTION DRUG LABEL	3	10223-0221	GEL	0.00 g	TOPICAL	UNAPPROVED DRUG OTHER	11 sections
Comfortox Tetracaine	HUMAN OTC DRUG LABEL	1	54723-997	CREAM	20 mg	TOPICAL	OTC monograph not final	11 sections
Cutiecaine	HUMAN OTC DRUG LABEL	2	50876-182	CREAM	20 mg	TOPICAL	OTC monograph not final	10 sections

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