Pregnancy Category B: Reproduction studies have been performed in rats and mice at doses up to 3200 mg/kg per day (23 times the recommended human dose based on mg/m2) and have revealed no evidence of harm to the fetus due to Cefuroxime axetil. 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.