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Darflox should not be used in pregnant women or women who may possibly be pregnant. (The safety of prulifloxacin in pregnant women has not been established.)
In the teratogenicity study (30, 300 and 3000 mg/kg) in rats, inhibited fetal development was observed at the higher dose, while in the teratogenicity study (10, 30 and 100 mg/kg) in rabbits, increased frequency of premature delivery and fetal death in late pregnancy were noted. However, teratogenic action was not found in these studies. It is advisable to avoid using prulifloxacin in lactating mothers. If use of this product is judged to be essential, breastfeeding must be discontinued during treatment.
[It has been reported that prulifloxacin is excreted in breast milk in animal studies (rats).]
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