PROPARACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5% 15ML
Generic: Proparacaine Hydrochloride
PROPARACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5% 15ML
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Identification
Proparacaine Hydrochloride
Proparacaine Hydrochloride
Bausch & Lomb Incorporated
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION/ DROPS
OPHTHALMIC
ANDA040074
Active Ingredients
| Ingredient | Strength |
|---|---|
| PROPARACAINE HYDROCHLORIDE | 5 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
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.
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.
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
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 .
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.