"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
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.
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.
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.
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.
Last reviewed on RxList: 11/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Alcaine Information
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