Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution 0.5% is supplied in 15 mL DROP-TAINER* dispensers. NDC: 70518-3408-00 PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE TYPE 0 Storage: Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2° - 8°C (36° - 46°F). Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: Proparacaine Hydrochloride GENERIC: Proparacaine Hydrochloride DOSAGE: SOLUTION/ DROPS ADMINSTRATION: OPHTHALMIC NDC: 70518-3408-0 PACKAGING: 15 mL in 1 BOTTLE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): PROPARACAINE HYDROCHLORIDE 5mg in 1mL INACTIVE INGREDIENT(S): BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE MM1
- HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution 0.5% is supplied in 15 mL DROP-TAINER* dispensers. NDC: 70518-3408-00 PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE TYPE 0 Storage: Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2° - 8°C (36° - 46°F). Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
- DRUG: Proparacaine Hydrochloride GENERIC: Proparacaine Hydrochloride DOSAGE: SOLUTION/ DROPS ADMINSTRATION: OPHTHALMIC NDC: 70518-3408-0 PACKAGING: 15 mL in 1 BOTTLE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): PROPARACAINE HYDROCHLORIDE 5mg in 1mL INACTIVE INGREDIENT(S): BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE MM1
Overview
Proparacaine hydrochloride ophthalmic solution 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula: Established name: Proparacaine Hydrochloride Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Molecular Weight: 330.85 Each mL contains: Active: proparacaine hydrochloride 5mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin; and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. chemical
Indications & 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
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 should be clear to straw-color. If the solution becomes darker, discard the solution.
Warnings & Precautions
WARNINGS NOT FOR INJECTION - 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.
Contraindications
Proparacaine hydrochloride ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
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 also been reported.
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