Pregnancy: Teratogenic Effects: Pregnancy and Category B: Reproduction studies have been performed in rats, mice and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefazolin (Fazef). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Category B1.
Safety of this product for use during pregnancy has not been established in human clinical trials. Studies in animals are inadequate or lacking but available data shows no evidence of an increased occurrence of fetal damage. Studies of cord blood show prompt transfer of cefazolin across the placenta. Drug level in cord blood were approximately one quarter to one third of maternal drug levels.
Labor and Delivery: When cefazolin has been administered prior to caesarean section, drug levels in cord blood have been approximately one quarter to one third of maternal drug levels. The drug appears to have no adverse effect on the fetus.
Nursing Mothers: Cefazolin (Fazef) is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when Cefazolin (Fazef) is administered to a nursing woman.
Lactation: Cefazolin is present in very low concentration in the milk of breast feeding mothers. Safety for use in lactating women has not been established.
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