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.