Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% (Sterile)

Rx only

Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is a topical anesthetic prepared as a sterile aqueous ophthalmic solution. The active ingredient is represented by the following structural formula:

C₁₆H₂₆N₂O₃ • HCI

Mol. wt.: 330.85

Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride.

Each mL Contains:

ACTIVE: Proparacaine Hydrochloride 5 mg (0.5%); INACTIVES: Glycerin, Hydrochloric Acid, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

Proparacaine is a rapid acting local anesthetic suitable for ophthalmic use. With a single drop, the onset of anesthesia usually begins within 30 seconds and persists for 15 minutes or longer.

The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane. As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases. When this action is sufficiently well developed, block of conduction is produced.

The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migrate in the lipid layer of the nerve cell membrane. This limitation prevents the fundamental change necessary for the generation of the action potential.

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.

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

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacifiction with accompanying loss of vision.

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.

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 OPHTHALMIC USE ONLY

Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied in a plastic bottle with a controlled drop tip in the following size:

15 mL bottle - Prod. No. 04711

Refrigerate at 2°-8°C (36°- 46°F). Protect from light. Keep tightly closed.

Do not use if the solution shows more than a faint yellow color.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Rx only

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

Revised November 2007

9114400 (Folded)
9114500 (Flat)

NDC 24208-730-06

Bausch & Lomb

Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% (Sterile)

Rx only

[icon- eye] [icon- 0.5%] [icon-solution] [icon- 15 mL]

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444