Objective To study the repeated oral dose toxicity of
Loteprednol Etabonate in dogs by 18 weeks consecutive administration.Methods
Twenty four dogs were randomized into four groups.Dogs were given
Loteprednol Etabonate at 5,15 and 30mg·kg~(-1)·d~(-1) for 18 weeks.Some of the animals for each group were subjected to the 2weeks recovery test after the treatment with the drug. Clinical symptoms were observed and laboratory tests were examined. Results At a dose of 5mg·kg~(-1)·d~(-1),no apparent changes induced by the drug were observed.Dogs treated with 15 and 30mg·kg~(-1)·d~(-1) showed decrease in the body weight gain,increases in the proportion of monocytes.In additon to these changes,dogs at dose of 30mg·kg~(-1)·d~(-1)showed increases in ALP activities and protein content in urine,decreases in total protein,creatinine and total cholesterol levels.In this group,one male dog died on the 8th day,and one dog showed some chronic inflammation on the liver,some hepatic cells degeneration, cytoplasmic vacuolization and pyknonucleous.These changes induced by Loteprednol Etabonate disappeared and tended to disappear during the recovery period for 2 weeks.Conlusion The
no-toxic-effect dose of the drug is 5mg·kg~(-1)·d~(-1).