Tetracaine Hydrochloride (EENT) (Monograph)

Drug class: Local Anesthetics

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Tetracaine is an ester local anesthetic.¹

Uses for Tetracaine Hydrochloride (EENT)

Tetracaine has the following uses:

Tetracaine hydrochloride ophthalmic solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.¹

Tetracaine Hydrochloride (EENT) Dosage and Administration

General

Tetracaine is available in the following dosage form(s) and strength(s):

Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride.¹ Supplied in single patient use dispensers.¹

Administration

Apply topically to the eye in the form of a 0.5% solution.¹

Not for injection or intraocular use; do not use intracamerally.¹

Administer under the direct supervision of a healthcare provider; not intended for patient self-administration.¹

Open package using standard aseptic technique.¹ The dispenser may then be allowed to fall upon a sterile surface.¹ The entire outer surface of the dispenser and its contents are sterile.¹

Each dispenser is for single patient use and does not contain a preservative; discard any unused portion.¹

Store at 2°C to 8°C; protect contents from light.¹ Do not use if solution contains crystals, is cloudy, or discolored.¹

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

To produce local ophthalmic anesthesia, the usual dose is 1 drop topically in the eye(s) as needed.¹

Cautions for Tetracaine Hydrochloride (EENT)

Contraindications

None¹

Warnings/Precautions

Corneal Injury with Intracameral Use

Tetracaine hydrochloride ophthalmic solution is not for injection or intraocular use.¹ Do not use intracamerally because such use may lead to damage of the corneal endothelial cells.¹

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.¹

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.¹

Administration Precautions

Tetracaine hydrochloride ophthalmic solution 0.5% is indicated for administration under the direct supervision of a healthcare provider.¹ The drug is not intended for patient self-administration.¹

Specific Populations

Pregnancy

There are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution in pregnant women.¹ Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.¹

Lactation

There are no data to assess whether tetracaine hydrochloride ophthalmic solution is excreted in human milk or to assess its effects on milk production/excretion.¹ The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from tetracaine or from the underlying maternal condition.¹

Females and Males of Reproductive Potential

No human data on the effect of tetracaine hydrochloride ophthalmic solution on fertility are available.¹

Pediatric Use

Safety in the pediatric population has been demonstrated in clinical trials.¹ 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.¹

Geriatric Use

No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.¹

Common Adverse Effects

Ocular adverse events: stinging, burning, conjunctival redness.¹

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.¹

Topical administration of tetracaine hydrochloride ophthalmic solution results in localized temporary anesthesia.¹ The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes.¹ Duration of effect can be extended with repeated dosing.¹

Advice to Patients

• Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries.¹

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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