Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution USP, 0.5% is supplied in a low density polyethylene white bottle with a natural dropper tip with a white screw cap in the following size: NDC 70756-193-35 15 mL bottle in carton. Storage: Refrigerate at 2°C to 8° C (36°F to 46°F). Keep bottle tightly closed. Store bottles in carton until empty to protect from light. If solution shows more than a faint yellow color, it should not be used. DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING. Keep out of reach of children. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Switzerland Revised: July 2024, V-02; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-193-35 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (Sterile) For eye use only Not for injection 15 mL Rx only NDC 70756-193-35 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% For eye use only (Sterile) Not for injection 15 mL Rx only label carton
- HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution USP, 0.5% is supplied in a low density polyethylene white bottle with a natural dropper tip with a white screw cap in the following size: NDC 70756-193-35 15 mL bottle in carton. Storage: Refrigerate at 2°C to 8° C (36°F to 46°F). Keep bottle tightly closed. Store bottles in carton until empty to protect from light. If solution shows more than a faint yellow color, it should not be used. DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING. Keep out of reach of children. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Switzerland Revised: July 2024, V-02
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-193-35 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (Sterile) For eye use only Not for injection 15 mL Rx only NDC 70756-193-35 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% For eye use only (Sterile) Not for injection 15 mL Rx only label carton
Overview
Proparacaine hydrochloride ophthalmic solution USP is a local anesthetic for ophthalmic instillation. Each mL of sterile aqueous solution contains 5 mg proparacaine hydrochloride with glycerin as a stabilizer, sodium hydroxide or hydrochloric acid to adjust the pH, and 2 mg chlorobutanol (chloral derivative) and benzalkonium chloride as antimicrobial preservatives. At the time of manufacture, the air in the container is replaced by nitrogen. Proparacaine hydrochloride is designated chemically as 2-(Diethylamino) ethyl 3-amino-4- propoxybenzoate monohydrochloride. Graphic formula: Proparacaine Hydrochloride molecular structure representation
Indications & Usage
Proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
Dosage & Administration
Deep anesthesia as in cataract extraction: Instill 1 drop every 5 to 10 minutes for 5 to 7 doses. Removal of sutures: Instill 1 or 2 drops 2 or 3 minutes before removal of stitches. Removal of foreign bodies: Instill 1 or 2 drops prior to operating. Tonometry: Instill 1 or 2 drops immediately before measurement
Warnings & Precautions
WARNINGS For topical ophthalmic use only. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of vision. Proparacaine ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. Proparacaine ophthalmic solution is not intended for patient self-administration.
Contraindications
This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.
Adverse Reactions
Pupillary dilation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking. However, some local irritation and stinging may occur several hours after the instillation. Rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which includes 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. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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