Proparacaine Hydrochloride
Generic: PROPARACAINE HYDROCHLORIDE
Basic Information
Manufacturer
Bausch & Lomb Incorporated
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
b699f838-8b69-4bac-953b-ea8822ec19fc
Indications & Usage
INDICATIONS AND USAGE Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated; corneal anesthesia of short duration, e.g.
tonometry, gonioscopy, removal of corneal foreign bodies and for short corneal and conjunctival procedures.
tonometry, gonioscopy, removal of corneal foreign bodies and for short corneal and conjunctival procedures.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE - 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.
It may produce permanent corneal opacification with accompanying visual loss.
Adverse Reactions
ADVERSE REACTIONS 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 from proparacaine with drying and fissuring of the fingertips has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 from proparacaine with drying and fissuring of the fingertips has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .