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Drug ReportsTetracaine
Tetracaine
Kovanaze, Pliaglis, Synera, Tetracaine (tetracaine) is a small molecule pharmaceutical. Tetracaine was first approved as Synera on 2005-06-23. It is used to treat pain in the USA.
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FDA approval date
EMA approval date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Tetracaine
Combinations
Kovanaze (discontinued: Pliaglis, Synera)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lidocaine
+
Tetracaine
Tradename
Company
Number
Date
Products
SYNERAGalen PharmaN-021623 DISCN2005-06-23
1 products, RLD
PLIAGLISTaro PharmaceuticalN-021717 DISCN2006-06-29
1 products, RLD
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Tetracaine hydrochloride
Tradename
Company
Number
Date
Products
TETRACAINE HYDROCHLORIDEAlcon ResearchN-208135 RX2016-02-29
1 products, RLD, RS
TETRACAINE HYDROCHLORIDEBausch Health CompaniesN-210821 RX2019-03-12
1 products, RLD, RS
Oxymetazoline hydrochloride
+
Tetracaine hydrochloride
Tradename
Company
Number
Date
Products
KOVANAZESt RenatusN-208032 RX2016-06-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
benzocaine 20% / lidocaine 10% / tetracaine 10%unapproved drug other2019-05-22
blockaidunapproved drug other2022-05-06
blt 3C2002632024-02-04
blt skin creamC2002632024-10-18
blue gel anestheticC2002632024-05-06
burn creamOTC monograph not final2019-12-18
burn solution creamOTC monograph not final2021-04-26
cetacaine anestheticunapproved drug other2023-05-11
cetacaine topical anestheticunapproved drug other2022-01-17
comfortox tetracaineC2002632023-11-03
Show 23 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
ventricular tachycardia—D017180I47.2
cardiac arrhythmiasEFO_0004269D001145I49.9
burns—D002056T30.0
esophageal diseasesEFO_0009544D004935K22.9
ventricular fibrillationHP_0001663D014693I49.01
ventricular premature complexes—D018879I49.3
mouth diseasesEFO_1001047D009059K13
paroxysmal tachycardiaEFO_0009493D013614I47
sinusitisEFO_0007486D012852J32
Show 3 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Lidocaine / Tetracaine, Pliaglis, Taro
103501802031-01-14DP
106032932031-01-14DP
107513052031-01-14DP
Oxymetazoline Hydrochloride / Tetracaine Hydrochloride, Kovanaze, St Renatus
85802822030-04-02DPU-1876
93081912030-04-02DPU-1876
ATC Codes
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AD: Local anesthetics for treatment of hemorrhoids and anal fissures for topical use
— C05AD02: Tetracaine
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AB: Anesthetics for topical use
— D04AB06: Tetracaine
N: Nervous system drugs
— N01: Anesthetics
— N01B: Local anesthetics
— N01BA: Esters of aminobenzoic acid for local anesthesia
— N01BA03: Tetracaine
— N01BA53: Tetracaine, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01H: Local anesthetics, ophthalmologic
— S01HA: Local anesthetics
— S01HA03: Tetracaine
HCPCS
Code
Description
C9285
Lidocaine 70 mg/tetracaine 70 mg, per patch
Clinical
Clinical Trials
142 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R522499428
AnesthesiaD000758——2641114
Local anesthesiaD000772———11337
Healthy volunteers/patients———3——216
LacerationsD022125———1—214
Procedural painD000073818————12—3
Drug-related side effects and adverse reactionsD064420—T88.7———123
Linear energy transferD018499—————2—2
Dental anesthesiaD000766———1—1—2
Dental pulp diseasesD003788EFO_0009540K04———2—2
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CataractD002386HP_0000518H26.9——2—24
Corneal injuriesD065306HP_0000559——12—13
InfectionsD007239EFO_0000544———2——2
Communicable diseasesD003141————2——2
KeratitisD007634HP_0000491H16——2——2
AnalgesiaD000698————1—12
BehaviorD001519GO_0007610———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PeriodontitisD010518EFO_0000649K05.3—3———3
Dental cariesD003731EFO_0003819K02—3———3
Periapical periodontitisD010485EFO_1001391K04.5—3———3
Shoulder impingement syndromeD019534EFO_1001178M75.4—2———2
PhlebotomyD018962———2———2
SyndromeD013577———2———2
NeuralgiaD009437EFO_0009430——1——12
Otitis externaD010032EFO_0009560H60—1———1
Lacrimal duct obstructionD007767——11———1
Shoulder painD020069HP_0030834M25.51—1———1
Show 15 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlaucomaD005901EFO_0000516H401———45
RetinoblastomaD012175——1————1
Intraocular pressureD007429——1————1
Hearing lossD034381EFO_0004238H91.91————1
Meniere diseaseD008575EFO_0006862H81.01————1
Sensorineural hearing lossD006319HP_0000407H90.51————1
Intratympanic injectionD000069555——1————1
AbscessD000038EFO_0003030—1————1
Eye painD058447HP_0200026H57.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.30————55
Open-angle glaucomaD005902EFO_0004190H40.1————33
Exfoliation syndromeD017889EFO_0004235—————33
Skin agingD015595EFO_0005422—————33
Postoperative complicationsD011183——————22
AgingD000375GO_0007568R41.81————22
Ocular hypertensionD009798EFO_1001069H40.0————22
Wet macular degenerationD057135EFO_0004683—————22
Cutis laxaD003483—Q82.8————22
RecurrenceD012008——————11
Show 40 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTetracaine
INNtetracaine
Description
Tetracaine is a benzoate ester in which 4-N-butylbenzoic acid and 2-(dimethylamino)ethanol have combined to form the ester bond; a local ester anaesthetic (ester caine) used for surface and spinal anaesthesia. It has a role as a local anaesthetic. It is a benzoate ester and a tertiary amino compound.
Classification
Small molecule
Drug classlocal anesthetics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Identifiers
PDB—
CAS-ID94-24-6
RxCUI—
ChEMBL IDCHEMBL698
ChEBI ID9468
PubChem CID5411
DrugBankDB09085
UNII ID0619F35CGV (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Tetracaine
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,446 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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631 adverse events reported
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