NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY.

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

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. Do not touch dropper tip to any surface as this may contaminate the solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with ALCAINE 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® 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.

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