Darflox Special Precautions

Careful Administration (Darflox should be administered with care in the following patients): Patients with severe renal disorder [since high blood concentration persists, the dose should be reduced or dosing intervals should be prolonged (see Pharmacokinetics under Actions)]; patients with convulsive disorders eg, epilepsy or with a history thereof (convulsions may occur); elderly.
Dysarthrosis has been observed in animal studies (juvenile dogs: Dose 20 and 80 mg/kg/day for 7 consecutive days).
In the animal study using monkeys, accumulation of ulifloxacin has been observed in the eyes (choroid, pigment epithelium) after long-term administration for 52 weeks.
In the case of patients with a remarkably low stomach acid state eg, achlorhydria, it is considered that the absorption of Darflox is decreased by the elevated pH in the stomach and the decreased solubility of Darflox.
Carcinogenicity: In the medium-term carcinogenicity study in rats (0.15%, 0.5% and 1.5% in diet), prulifloxacin slightly increased the generation of GST-P positive hepatocellular foci in the liver at the higher dose, but this was regarded as a very minor change in view of the high dose at which it occurred as well as its minor level. Moreover, no neoplastic lesion was found by the histopathological examination.
Mutagenicity: In the chromosomal aberration test using in vitro CHL cells, prulifloxacin increased the frequency of occurrence of cells with structural chromosome aberrations. However, no mutagenicity was detected in the reverse mutation test in bacteria, chromosomal aberration tests in human peripheral blood lymphocytes and in micronucleus test in mice.
Use in the elderly: Because pharmacokinetic studies in elderly patients have shown prolonged half-life of prulifloxacin and high blood concentration may persist, Darflox should be administered with care eg, reduction of the dose or prolonging dosing intervals (see Pharmacokinetics under Actions).