Z-Fix 400 Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Potential benefit should justify the potential risk when cefixime is used during pregnancy.
Labor and Delivery: The effect of cefixime in labor and delivery is unknown.
Lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with cefixime.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In rats, fertility and reproductive performance were not affected by cefixime at doses up to 125 times the adult therapeutic dose.
Usage in Pregnancy: Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of harm to the fetus due to cefixime.
There are 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.