Clinical medicine profile
Tetracaine
Therapeutic agent (verify pharmacological class)
- Route
- OPHTHALMIC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- 5 WARNINGS AND PRECAUTIONS Do not use intracamerally since use may damage corneal endothelial cells ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.
- ( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.
- ( 5.3 ) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration.
- ( 5.4 ) 5.1 Corneal injury with Intracameral Use Not for injection or intraocular use.
- Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells. 5.2 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. 5.3 Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.4 For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider.
- Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )].
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1 ) 2.1 Topical Administration One drop topically in the eye as needed. Discard unused portion. 2.2 Sterile Field Administration Open package using standard aseptic technique. The DROP‑TAINER ® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROP‑TAINER ® dispenser and its contents are sterile.
8.4 Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- 1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
- Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Adverse effects
- 6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%.
- Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.
- Ocular adverse events: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Open multi-drug checker ↗- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Mechanism & disposition
12.
Read complete mechanism
12.1 Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.
Product-specific
Product-specific
OPHTHALMIC
Pregnancy, lactation & diet
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. 8.2 Lactation Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available. 8.4 Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. 8.5 Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.