proparacaine hydrochloride PROPARACAINE HYDROCHLORIDE NUCARE PHARMACEUTICALS,INC. FDA Approved ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 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 5 mg 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
FunFoxMeds bottle
Route
OPHTHALMIC
Applications
ANDA080027
Package NDC

Drug Facts

Composition & Profile

Strengths
0.5 % 15 ml
Quantities
15 ml
Treats Conditions
Indications And Usage Alcaine 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

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0368071513950
UNII
U96OL57GOY
Packaging

HOW SUPPLIED: ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in 15 mL DROP-TAINER ® dispensers. NDC 68071-5139-5 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 ©2004 Alcon, Inc. ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA Printed in USA [email protected] 1-800-757-9195 249039-0609; PRINCIPAL DISPLAY PANEL pdp

Package Descriptions
  • HOW SUPPLIED: ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in 15 mL DROP-TAINER ® dispensers. NDC 68071-5139-5 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 ©2004 Alcon, Inc. ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA Printed in USA [email protected] 1-800-757-9195 249039-0609
  • PRINCIPAL DISPLAY PANEL pdp

Overview

ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 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 5 mg 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

: ALCAINE ® 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: ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 0.5% 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

: ALCAINE ® 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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