Tetracaine
Active ingredient · 4 therapeutic classes
- Drug class
- Local Anesthetics
- Availability
- Prescription only
- Routes
- Ophthalmic, Topical
- Markets covered
- 3
- Products on record
- 7
Overview
Tetracaine is an active pharmaceutical ingredient in the Local Anesthetics group (C05AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 5 | November 21, 2025 |
| US United States | FDA | 1 | May 22, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
5 products
Uses
Ocular anaesthetic for topical instillation into the conjunctival sac.
How to take
USUnited States· FDA
1 product
Uses
5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. 5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )
How to take
CACanada· Health Canada
1 product
Uses
AMETOP
Gel 4% (Tetracaine Hydrochloride Gel) is indicated for: Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture or venous cannulation, including intravenous injections of medications. 1 Pediatrics Pediatrics (older than one month and in the case of premature babies: 1 month after the expected delivery date (44 gestation weeks) – 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of AMETOP Gel 4% in pediatric patients has been established.
Therefore, Health Canada has authorized an indication for pediatric use. 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
There is no significant difference in pseudocholinesterase activity in men between the ages of 16 – 94 years and women aged 40 – 99years.
Drug interactions
Known interactions involving Tetracaine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL034680082 · revised November 21, 2025
- [2]FDA DailyMed · 01fba5f8-a60a-44… · revised May 22, 2025 [PDF]
- [3]Health Canada (DPD) · 02230575 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.