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In reproduction studies on rats at doses up to 5 times the human dose and rabbits at doses up to 3 times the human dose, fetotoxicity has not been reported.
In a controlled clinical study, the potential ototoxic and nephrotoxic effects of this drug on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal injections. This drug was found in cord blood and no sensorial hearing loss or nephrotoxicity attributable to this drug was noted.
One infant whose mother received this drug in the third trimester experienced conducive hearing loss. Because the number of patients treated in this study was limited and this drug was administered only in the second and third trimesters, it is not known whether this drug causes fetal harm.
Because the safety of this drug during pregnancy has not been established, the drug should be administered to pregnant women or women of child bearing potential only if therapeutic benefit is judged to overweight the potential risk. If administered, serum concentration should be carefully monitored to reduce fetotoxicity.
Because the drug is excreted in human milk, nursing mothers should avoid administration of the drug. If treatment is unavoidable, nursing should be discontinued.
