Proparacaine Hydrochloride

Description

DESCRIPTION Proparacaine hydrochloride ophthalmic solution USP, 0.5% is a local anesthetic for ophthalmic instillation. Each mL of sterile aqueous solution contains active ingredient: proparacaine hydrochloride 5 mg (0.5%) and inactive ingredients: glycerin (tonicity agent), benzalkonium chloride, 0.01% (preservative) and water for injection (vehicle). The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. 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: C 16 H 26 N 2 O 3

What Is Proparacaine Hydrochloride Used For?

INDICATIONS AND 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 and Administration

DOSAGE AND 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

Side Effects (Adverse Reactions)

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 Micro Labs USA, Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications

CONTRAINDICATIONS This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

Pregnancy and Breastfeeding

Pregnancy Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution, 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.

How Supplied

HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution USP, 0.5% is supplied in a 3-piece white low density polyethylene S design container with natural low density polyethylene S design open nozzle and white color high density polyethylene S design cap with TSTR- tear off ring. 15 mL fill in 15 mL Container NDC 42571-497-57 Storage: Refrigerate at 2° to 8° C. 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. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev. 01/2025