Loteprednol Etabonate

Contraindications

CONTRAINDICATIONS Loteprednol etabonate ophthalmic suspension, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Pregnancy & Breastfeeding

Pregnancy Teratogenic effects: 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/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/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis with 50 mg/kg/day or 100 mg/kg/day (600 and 1,200 times the maximum clinical dose) resulted in embryotoxicity (increased post-implantation losses with 100 mg/kg/day and decreased fetal body weight and skeletal ossification with 50 mg/kg/day and 100 mg/kg/day); doses of 5 (60 times the maximum daily clinical dose), 50 mg/kg/day and 100 mg/kg/day caused teratogenicity (absent innominate artery at all doses and cleft palate and umbilical hernia at 50 mg/kg/day and 100 mg/kg/day). 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/day to 100 mg/kg/day but not at 0.5 mg/kg/day. The NOELs for the embryotoxic and teratogenic effects in rats were 5 mg/kg/day and 0.5 mg/kg/day (60 and 6 times the maximum daily clinical dose) for embryotoxicity and teratogenicity, respectively. Oral exposure of pregnant rats to 5 mg/kg/day and 50 mg/kg/day of loteprednol etabonate during the fetal period, a maternally toxic treatment regimen (significantly decreased body weight gain), resulted in teratogenicity (umbilical herniation) and embryotoxicity (decreased fetal birth weight); the NOEL for these effects was 0.5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/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 g