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LOTEMAX (LOTEPREDNOL): USE IN SPECIFIC POPULATIONS
Loteprednol Etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg / kg per day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg / kg per day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis
resulted in teratogenicity (absent innominate artery at >= 5 mg / kg per day doses, and cleft palate and umbilical hernia at >= 50 mg / kg per day) and embryotoxicity (increased post-implantation losses at 100 mg / kg per day and decreased fetal body weight and skeletal ossification with >= 50 mg / kg per day). Treatment of rats with 0.5 mg / kg per day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of >= 5 mg / kg per day.
Oral exposure of female rats to 50 mg / kg per day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg / kg per day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg / kg per day during the fetal period.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Loteprednol (Lotemax) eye drops 0.5% is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
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