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Gemifloxacin treatment during organogenesis caused fetal growth retardation in mice (oral dosing at 450 mg/kg/day), rats (oral dosing at 750 mg/kg/day) and rabbits (IV dosing at 40 mg/kg/day). Treatment of pregnant rats at 750 mg/kg/day caused fetal brain and ocular malformations (unilateral microphthalmia, anophthalmia, and dome shaped head) in the presence of maternal toxicity.
Factive should not be used in pregnant women because the safety of Factive in pregnant women has not been established.
Stop breast-feeding during the administration of Factive because animal studies have shown gemifloxacin-related material is excreted in the breast milk of rats.
