Patients with a history of hypersensitivity to any of the ingredients of Darflox. Patients receiving treatment with fenbufen, flurbiprofen axetil or flurbiprofen (see Interactions).
Use in Pregnancy & Lactation: 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).]
Use in Children: Since the safety of prulifloxacin in low birth weight infants, newborns, suckling infants, infants and children has not been established, this product should not be administered to pediatric patients.