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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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YTD
1Y
2Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Primary completion 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
Hide discontinued
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 3C2002632026-01-12
blt skin creamC2002632025-12-04
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
Show 18 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 fibrillationEFO_0004287D014693I49.01
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
150 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_0003843R522597528
AnesthesiaD000758——2641114
Local anesthesiaD000772———11337
Healthy volunteers/patients———3——216
LacerationsD022125———1—315
AgnosiaD000377EFO_0007136F88—1—3—4
Procedural painD000073818————12—3
Drug-related side effects and adverse reactionsD064420—T88.7———123
Pain managementD059408———1—2—3
Linear energy transferD018499—————2—2
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Corneal injuriesD065306———12—24
CataractD002386EFO_0001059H26.9——2—24
Communicable diseasesD003141————2——2
KeratitisD007634—H16——2——2
AnalgesiaD000698————1—12
InfectionsD007239EFO_0000544———1——1
BehaviorD001519GO_0007610STY/T053——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
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
Postherpetic neuralgiaD051474——12———2
Otitis externaD010032EFO_0009560H60—1———1
Lacrimal duct obstructionD007767——11———1
Shoulder painD020069—M25.51—1———1
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlaucomaD005901EFO_0000516H401———34
RetinoblastomaD012175——1————1
Intraocular pressureD007429——1————1
Hearing lossD034381EFO_0004238H91.91————1
Meniere diseaseD008575EFO_0006862H81.01————1
Sensorineural hearing lossD006319—H90.51————1
Intratympanic injectionD000069555——1————1
LentigoD007911—L81.41————1
AbscessD000038EFO_0003030—1————1
Eye painD058447—H57.11————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Macular degenerationD008268EFO_0001365H35.30————66
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
KeratoconusD007640EFO_0004223H18.6————22
Show 48 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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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,801 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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667 adverse events reported
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