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
Trade Name
FDA
EMA
Tetracaine
CombinationsKovanaze (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 |
|---|---|---|---|---|
| SYNERA | Galen Pharma | N-021623 DISCN | 2005-06-23 | 1 products, RLD |
| PLIAGLIS | Taro Pharmaceutical | N-021717 DISCN | 2006-06-29 | 1 products, RLD |
Hide discontinued
Tetracaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TETRACAINE HYDROCHLORIDE | Alcon Research | N-208135 RX | 2016-02-29 | 1 products, RLD, RS |
| TETRACAINE HYDROCHLORIDE | Bausch Health Companies | N-210821 RX | 2019-03-12 | 1 products, RLD, RS |
Oxymetazoline hydrochloride
+
Tetracaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KOVANAZE | St Renatus | N-208032 RX | 2016-06-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| benzocaine 20% / lidocaine 10% / tetracaine 10% | unapproved drug other | 2019-05-22 |
| blockaid | unapproved drug other | 2022-05-06 |
| blt 3 | C200263 | 2025-01-27 |
| blt skin cream | C200263 | 2024-10-18 |
| burn cream | OTC monograph not final | 2019-12-18 |
| burn solution cream | OTC monograph not final | 2021-04-26 |
| cetacaine anesthetic | unapproved drug other | 2025-01-10 |
| cetacaine topical anesthetic | unapproved drug other | 2022-01-17 |
| comfortox tetracaine | C200263 | 2023-11-03 |
| eclipse topical analgesic | OTC monograph not final | 2018-08-06 |
Show 19 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
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
141 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 2 | 4 | 9 | 7 | 5 | 27 |
| Anesthesia | D000758 | — | — | 2 | 6 | 4 | 1 | 1 | 14 |
| Local anesthesia | D000772 | — | — | — | 1 | 1 | 3 | 3 | 7 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 2 | 1 | 6 |
| Lacerations | D022125 | — | — | — | 1 | — | 2 | 1 | 4 |
| Procedural pain | D000073818 | — | — | — | — | 1 | 2 | — | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | 2 | 3 |
| Linear energy transfer | D018499 | — | — | — | — | — | 2 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | 1 | 2 |
| Dental anesthesia | D000766 | — | — | — | 1 | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | 2 | — | 2 | 4 |
| Corneal injuries | D065306 | — | — | — | 1 | 2 | — | 1 | 3 |
| Communicable diseases | D003141 | — | — | — | — | 2 | — | — | 2 |
| Keratitis | D007634 | — | H16 | — | — | 2 | — | — | 2 |
| Analgesia | D000698 | — | — | — | — | 1 | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Behavior | D001519 | GO_0007610 | STY/T053 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dental caries | D003731 | EFO_0003819 | K02 | — | 3 | — | — | — | 3 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | 3 | — | — | — | 3 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | 2 | — | — | — | 2 |
| Phlebotomy | D018962 | — | — | — | 2 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | 1 | 2 |
| Otitis externa | D010032 | EFO_0009560 | H60 | — | 1 | — | — | — | 1 |
| Lacrimal duct obstruction | D007767 | — | — | 1 | 1 | — | — | — | 1 |
| Shoulder pain | D020069 | — | M25.51 | — | 1 | — | — | — | 1 |
| Palliative care | D010166 | — | — | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | — | — | — | 3 | 4 |
| Retinoblastoma | D012175 | — | — | 1 | — | — | — | — | 1 |
| Intraocular pressure | D007429 | — | — | 1 | — | — | — | — | 1 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | 1 | — | — | — | — | 1 |
| Meniere disease | D008575 | EFO_0006862 | H81.0 | 1 | — | — | — | — | 1 |
| Sensorineural hearing loss | D006319 | — | H90.5 | 1 | — | — | — | — | 1 |
| Intratympanic injection | D000069555 | — | — | 1 | — | — | — | — | 1 |
| Lentigo | D007911 | — | L81.4 | 1 | — | — | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | — | 1 | — | — | — | — | 1 |
| Eye pain | D058447 | — | H57.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 6 | 6 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | — | — | — | 3 | 3 |
| Exfoliation syndrome | D017889 | EFO_0004235 | — | — | — | — | — | 3 | 3 |
| Wet macular degeneration | D057135 | EFO_0004683 | — | — | — | — | — | 3 | 3 |
| Skin aging | D015595 | EFO_0005422 | — | — | — | — | — | 3 | 3 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 2 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 2 | 2 |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | — | — | 2 | 2 |
| Cutis laxa | D003483 | — | Q82.8 | — | — | — | — | 2 | 2 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
Show 41 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tetracaine |
| INN | tetracaine |
| 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 class | local anesthetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCNc1ccc(C(=O)OCCN(C)C)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 94-24-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL698 |
| ChEBI ID | 9468 |
| PubChem CID | 5411 |
| DrugBank | DB09085 |
| UNII ID | 0619F35CGV (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Tetracaine
Total medical expenditures per year (USD, in millions)
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Trends
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Additional graphs summarizing 6,904 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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640 adverse events reported
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