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Use in pregnancy: US FDA Pregnancy Category B: Reproduction studies have been performed in mice at doses up to 3200 mg/kg/day (14 times the recommended maximum human dose based in mg/m2) and in rats at doses up to 1000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or 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, Trigenna should be used during pregnancy only if clearly needed.
Use in lactation: Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.
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