A moderate amount of data on pregnant women pregnancy outcomes indicates no malformative or feto/neonatal toxicity. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin hydrochloride was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant, whose mother received vancomycin in the third trimester, experienced conductive hearing loss that was not attributable to vancomycin. Because vancomycin was administered only in the second and third trimesters, it is not known whether it causes foetal harm. Animal studies do not indicate reproductive toxicity. Blood levels should be monitored carefully to minimize the risk of foetal toxicity. Ceftriaxone crosses the placental barrier. Safety in human pregnancy has not been established. Reproductive studies in animals have shown no evidence of embryo toxicity, fetotoxicity, teratogenicity or adverse effects on male or female fertility, birth or perinatal and postnatal development. In primates, no embryo toxicity or teratogenicity has been observed. Therefore Vancoplus should not be used in pregnancy unless absolutely indicated.
Caution should be exercised when Vancoplus is administered to a nursing woman. Vancomycin is excreted in human milk, but at therapeutic doses of vancomycin no effects on the breastfed newborns/infants are anticipated. Caution should be exercised when Vancoplus is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of vancomycin from its gastro-intestinal tract