proparacaine hydrochloride

FDA Drug Profile — Alcaine, proparacaine hydrochloride

Drug Details

Generic Name
proparacaine hydrochloride
Brand Names
Alcaine, proparacaine hydrochloride
Application Number
ANDA080027
Sponsor
Alcon Laboratories, Inc.
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
PROPARACAINE HYDROCHLORIDE

Indications and Usage

INDICATIONS AND USAGE Proparacaine Hydrochloride Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.

Warnings

WARNINGS NOT FOR INJECTION INTO THE EYE - For topical ophthalmic use only. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of vision. Proparacaine ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. Proparacaine ophthalmic solution is not intended for patient self-administration.