Proparacaine Hydrochloride
Generic: PROPARACAINE HYDROCHLORIDE
Basic Information
Manufacturer
Sportpharm LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
4ae89863-233f-4015-92da-aad0f2a87677
Indications & 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.
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.
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
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.
Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch
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.
Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch