Proparacaine Hydrochloride (EENT) (Monograph)

Brand name: Alcaine
Drug class: Local Anesthetics

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

Introduction

Proparacaine hydrochloride is a rapidly-acting local anesthetic.

Uses for Proparacaine Hydrochloride (EENT)

Proparacaine has the following uses:

Proparacaine hydrochloride ophthalmic solution is used for producing local ophthalmic anesthesia during tonometry, gonioscopy, removal of corneal foreign bodies, and for short procedures involving the cornea and conjunctiva.

Proparacaine Hydrochloride (EENT) Dosage and Administration

General

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

Ophthalmic solution 0.5% supplied in 15 mL dispensers

Administration

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.

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

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

Store bottles under refrigeration at 2°C to 8°C in unit carton to protect contents from light.

After opening, proparacaine can be used until the expiration date on the bottle.

The ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

Dosage

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

Usual dosage in adults and pediatric patients: for removal of foreign bodies and sutures and for tonometry, apply 1 to 2 drops (in single instillations) in each eye before operating.

Short corneal and conjunctival procedures in adults and pediatric patients: apply 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

Cautions for Proparacaine Hydrochloride (EENT)

Contraindications

Known hypersensitivity to any of the ingredients of this preparation.

Warnings/Precautions

Administration Precautions

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

Proparacaine ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. The drug is not intended for patient self-administration.

Specific Populations

Pregnancy

Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution. It is also not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine should be administered to a pregnant woman only if clearly needed.

Lactation

It is not known whether proparacaine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine is administered to a nursing woman.

Females and Males of Reproductive Potential

Long-term studies in animals have not been performed to evaluate possible impairment of fertility in males or females.

Pediatric Use

Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children older than 12 years of age, and safety information in neonates and other pediatric patients.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Common Adverse Effects

Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported.

Allergic contact dermatitis with drying and fissuring of the fingertips has also been reported.

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

Proparacaine ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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