Alcaine (proparacaine)

ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution. 0.5% is supplied in 15 mL DROP-TAINER® dispensers.

Storage: Store at 2°-8°C. Keep refrigerated. Do not use the solution if darker than a pale yellow.

ALCON CANADA INC. Mississauga, Canada L5N 8C7. FDA Rev date: 12/23/2002

ALCAINE (proparacaine hydrochloride ophthalmic solution) (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.

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.

This preparation is contraindicated in patients with known hypersensitivity to any component of the solution. This product should never be prescribed for the patient's own use.

WARNINGS

For topical ophthalmic use only. Do not touch dropper tip to any surface as this may contaminate the solution. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of vision.

PRECAUTIONS

General

Proparacaine hydrochloride should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity of proparacaine is unknown, prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur. Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment oi fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution. 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.

Pediatric Use

Controlled clinical studies have not been performed with ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution to establish safety and effectiveness in children; however, the literature cites the use of proparacaine hydrochloride as a topical ophthalmic anesthetic agent in children.

SIDE EFFECTS

Pupillary dilatation 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.

DRUG INTERACTIONS

No information provided.

Pupillary dilatation 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.

No information provided.