As with other members of the quinolone class, trovafloxacin at doses 5 to 10 times the human dose based on mg/kg or 1 to 5 times the human dose based on mg/m² produces testicular degeneration in rats and dogs dosed for 6 months.

At a dose of trovafloxacin 10 times the highest human dose based on mg/kg or approximately 5 times based on mg/m², elevated liver enzyme levels which correlated with centrilobar hepatocellular vacuolar degeneration and necrosis were observed in dogs in a 6-month study. A subsequent study demonstrated reversibility of these effects when trovafloxacin was discontinued.

Azithromycin

Phospholipidosis (intracellular phospholipid binding) has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen and pancreas) in dogs administered doses which, based on pharmacokinetics, are as low as two times greater than the recommended adult human dose and in rats at doses comparable to the recommended adult human dose. This effect has been reversible after cessation of azithromycin treatment. The significance of these findings for humans is unknown.

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