Overview
Tetracaine is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.
Indication
Ophthalmic tetracaine is indicated for the for procedures requiring a rapid and short- acting topical ophthalmic anesthetic. The combination lidocaine and tetracaine patch is indicated for local dermal analgesia for superficial dermatological procedures and superficial venous access. The combination lidocaine and tetracaine cream is intended to provide topical local analgesia for superficial dermatological procedures.
Associated Conditions
- Dermabrasion
- Haemorrhoids
- Insect Bites
- Rash caused by poison ivy
- Sunburn
- Minor burns
Research Report
A Comprehensive Monograph on Tetracaine (Amethocaine): Pharmacology, Clinical Utility, and Safety Profile
Section 1: Identification and Historical Context
This section establishes the fundamental identity of Tetracaine, detailing its nomenclature, classification, and unique identifiers. It further places the drug within its historical and regulatory context, from its synthesis in the early 20th century to its modern status as an essential medicine.
1.1 Nomenclature and Chemical Classification
The local anesthetic Tetracaine is recognized globally by several names. Its United States Adopted Name (USAN) is Tetracaine, while its International Nonproprietary Name (INN) is Amethocaine.[1] Historically and commercially, it has also been known by various trade names, including Pontocaine, Dicaine, and Ametop.[1]
Chemically, its systematic International Union of Pure and Applied Chemistry (IUPAC) name is 2-(dimethylamino)ethyl 4-(butylamino)benzoate.[2] Tetracaine is classified as a local anesthetic belonging to the amino-ester class, a categorization critical to understanding its metabolic pathway, duration of action, and potential for allergic reactions.[1] It is specifically a benzoate ester, formed through the chemical combination of a lipophilic aromatic acid (4-N-butylbenzoic acid) and a hydrophilic amino alcohol (2-(dimethylamino)ethanol).[2] This amphipathic structure, possessing both fat-soluble and water-soluble components, is the archetypal design for local anesthetic agents and is fundamental to its ability to interact with and block neuronal membranes.
1.2 Key Identification Codes
For unambiguous identification in global databases, regulatory filings, and scientific literature, Tetracaine and its hydrochloride salt are assigned a comprehensive set of unique identifiers. These codes are essential for accurate cross-referencing and data retrieval.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/03/12 | Early Phase 1 | Active, not recruiting | Our Lady of the Lake Hospital | ||
2020/12/28 | Phase 3 | Completed | |||
2020/01/30 | Phase 1 | Completed | |||
2019/12/05 | Not Applicable | Completed | INTEGRIS Southwest Medical Center | ||
2019/02/18 | Phase 2 | UNKNOWN | |||
2018/11/21 | Not Applicable | UNKNOWN | |||
2018/04/18 | Phase 4 | Withdrawn | |||
2017/12/11 | Phase 4 | UNKNOWN | |||
2017/05/08 | Not Applicable | Completed | |||
2017/01/16 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Oceanside Pharmaceuticals | 68682-920 | OPHTHALMIC | 5 mg in 1 mL | 2/28/2022 | |
Bryant Ranch Prepack | 63629-9160 | ORAL | 10 mg in 1 mL | 2/2/2022 | |
REMEDYREPACK INC. | 70518-4183 | OPHTHALMIC | 5 mg in 1 mL | 5/22/2025 | |
Innovida Pharmaceutique Corporation | 71800-631 | TOPICAL | 70 mg in 1 g | 10/20/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-5079 | OPHTHALMIC | 5 mg in 1 mL | 2/19/2021 | |
Bausch & Lomb Incorporated | 24208-092 | OPHTHALMIC | 5 mg in 1 mL | 5/31/2022 | |
Akorn | 17478-045 | SUBARACHNOID | 10 mg in 1 mL | 4/14/2010 | |
St. Renatus | 69803-100 | NASAL | 30 mg in 1 mL | 11/16/2018 | |
Sincerus Florida, LLC | 72934-2140 | TOPICAL | 7 g in 100 g | 6/4/2020 | |
Cetylite Industries, Inc. | 10223-0202 | TOPICAL | 0.004 g in 0.2 g | 5/11/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 1% w/v | SIN04204P | SOLUTION | 0.01g/mL | 4/12/1990 | |
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 0.5% w/v | SIN04188P | SOLUTION | 0.005g/mL | 4/14/1990 | |
PLIAGLIS CREAM 70mg/g + 70mg/g | SIN14793P | CREAM | 7.00% w/w | 6/2/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MINIMS tetracaine (amethocaine) hydrochloride 0.5% 5 mg/mL eye drops tube | 32252 | Medicine | A | 10/30/1991 | |
MINIMS tetracaine (amethocaine) hydrochloride 1.0% 10 mg/mL eye drops tube | 32254 | Medicine | A | 10/30/1991 | |
LACERAINE GEL TOPICAL WOUND ANAESTHETIC vial | 443931 | Medicine | A | 3/18/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SUPRACAINE AEM 754MG/65GM | hoechst canada inc. | 00763667 | Metered-Dose Aerosol - Dental | 754 MG / 65 G | 12/31/1988 |
SPINAL ANESTHESIA TRAY | baxter corporation | 01909509 | Liquid - Subcutaneous
,
Block/Infiltration | 1 % / KIT | 12/31/1992 |
PONTOCAINE | hospira healthcare ulc | 02241978 | Powder For Solution - Intraspinal | 20 MG / 2 ML | 7/15/2001 |
DERMACAINE-R | innovatech inc | 02344971 | Cream - Topical | 2 % / W/W | N/A |
CETACAINE LIQUID | cetylite industries inc. | 02028867 | Liquid - Topical | 2 % | 9/19/1996 |
SUPRACAINE AEROSOL 11.6MG/GM | hoechst roussel canada inc. | 01987593 | Metered-Dose Aerosol - Topical
,
Oral | 11.6 MG / G | 12/31/1993 |
SPINAL ANESTHESIA TRAY | baxter corporation | 01975463 | Liquid - Block/Infiltration | 1 % / KIT | 12/31/1992 |
ZAP TOPICAL ANESTHETIC GEL | 01930699 | Gel - Topical | 2 % | 12/31/1992 | |
TRUE TEST | 02271885 | Patch - Topical | 0.073 MG | 3/16/2006 | |
VIRACTIN MOISTURIZING CREAM | medibrands israel (subsidiary of mediline ltd) | 02236789 | Cream - Topical | 2 % | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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