Proparacaine Hydrochloride
Proparacaine Hydrochloride is an FDA drug label for the active ingredient PROPARACAINE HYDROCHLORIDE manufactured by A-S Medication Solutions administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231210.
- Generic name
- PROPARACAINE HYDROCHLORIDE
- Manufacturer
- A-S Medication Solutions
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 50090-1923
- Application
- ANDA040074
- Label effective
- 20231210
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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. NOTE: Proparacaine hydrochloride ophthalmic solution USP, 0.5% should be clear, colorless to faint yellow color. If the solution becomes darker, discard the solution. FOR TOPICAL OPHTHALMIC USE ONLY
Contraindications
CONTRAINDICATIONS Proparacaine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
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.
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 .