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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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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 3C2002632025-01-27
blt skin creamC2002632024-10-18
burn creamOTC monograph not final2019-12-18
burn solution creamOTC monograph not final2021-04-26
cetacaine anestheticunapproved drug other2025-01-10
cetacaine topical anestheticunapproved drug other2022-01-17
comfortox tetracaineC2002632023-11-03
eclipse topical analgesicOTC monograph not final2018-08-06
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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 fibrillationEFO_0004287D014693I49.01
ventricular premature complexes—D018879I49.3
mouth diseasesEFO_1001047D009059K13
paroxysmal tachycardiaEFO_0009493D013614I47
sinusitisEFO_0007486D012852J32
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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
140 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnesthesiaD000758——154——10
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dental anesthesiaD000766———1———1
Indications Phases 1
No data
Indications Without Phase
No data
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 6,657 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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