FDA
Proparacaine Hydrochloride
The FDA lists this product in 7 strengths and forms.
Indications
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.
Contraindications
This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.
Warnings and precautions
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.
Adverse reactions
Pupillary dilation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking.
However, some local irritation and stinging may occur several hours after the instillation. Rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which includes 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. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.



