Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied as a sterile solution in a 15 mL white LDPE bottle with natural LDPE nozzle and white HDPE cap as follows: NDC 85766-039-15, 15 mL fill in a 15 mL capacity bottle (relabeled from NDC 70069-601-01) Storage: Refrigerate at 2° 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. Keep out of reach of children.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
- HOW SUPPLIED Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied as a sterile solution in a 15 mL white LDPE bottle with natural LDPE nozzle and white HDPE cap as follows: NDC 85766-039-15, 15 mL fill in a 15 mL capacity bottle (relabeled from NDC 70069-601-01) Storage: Refrigerate at 2° 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. Keep out of reach of children.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
Overview
Proparacaine hydrochloride ophthalmic solution USP, 0.5% is a local anesthetic for ophthalmic instillation. Each mL of sterile, aqueous solution contains: Active: Proparacaine Hydrochloride 5 mg (0.5%). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Glycerin as a stabilizer, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH, and Water for Injection USP. Proparacaine hydrochloride is designated chemically as 2-(Diethylamino) ethyl 3-amino-4- propoxybenzoate monohydrochloride. C 16 H 26 N 2 O 3 •HCl MW 330.85 CAS-5875-06-9 Image
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. FOR TOPICAL OPHTHALMIC USE ONLY
Warnings & Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE - 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 Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch
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