PRECAUTIONS
Information for Patients
SHAKE WELL BEFORE USING. To prevent contaminating the dropper tip and suspension, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Do not use if the suspension has discolored. Store at controlled room temperature. Protect from freezing.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Levocabastine was not carcinogenic in male or female rats or in male mice when administered in the diet for up to 24 months. In female mice, levocabastine doses of 5,000 and 21,500 times the maximum recommended ocular human use level resulted in an increased incidence of pituitary gland adenoma and mammary gland adenocarcinoma possibly produced by increased prolactin levels. The clinical relevance of this finding is unknown with regard to the interspecies differences in prolactin physiology and the very low plasma concentrations of levocabastine following ocular administration.
Mutagenic potential was not demonstrated for levocabastine when tested in Ames’ Salmonella reversion test or in Escherichia coli, Drosophila melanogaster, a mouse Dominant Lethal Assay or in rat Micronucleus test.
In reproduction studies in rats, levocabastine showed no effects on fertility at oral doses of 20 mg/kg/day (8,300 times the maximum recommended human ocular dose).
PREGNANCY
Teratogenic Effects
Pregnancy Category C.
Levocabastine has been shown to be teratogenic (polydactyly) in rats when given in doses 16,500 times the maximum recommended human ocular dose. Teratogenicity (polydactyly, hydrocephaly, brachygnathia), embryotoxicity, and maternal toxicity were observed in rats at 66,000 times the maximum recommended ocular human dose. There are no adequate and well-controlled studies in pregnant women. Levocabastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Based on determinations of levocabastine in breast milk after ophthalmic administration of the drug to one nursing woman, it was calculated that the daily dose of levocabastine in the infant was about 0.5 µg.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
|
