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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: ANIMAL PHARMACOLOGY
Lomefloxacin and other quinolones have been shown to cause arthropathy in juvenile animals. Arthropathy, involving multiple diarthrodial joints, was observed in juvenile dogs administered lomefloxacin at doses as low as 4.5 mg/kg for 7 to 8 days (0.3 times the recommended human dose based on mg/m2 or 0.6 times the recommended human dose based on mg/kg). In juvenile rats, no changes were observed in the joints with doses up to 91 mg/kg for 7 days (2 times the recommended human dose based on mg/m2 or 11 times the recommended human dose based on mg/kg).
In a 13-week oral rat study, gamma globulin decreased when Maxaquin (Lomefloxacin) pills were administered at less than the recommended human exposure. Beta globulin decreased when lomefloxacin was administered at 0.6 to 2 times the recommended human dose based on mg/m2. The A/G ratio increased when lomefloxacin was administered at 6 to 20 times the human dose. Following a 4-week recovery period, beta globulins in the females and A/G ratios in the females returned to control values. Gamma globulin values in the females and beta and gamma globulins and A/G ratios in the males were still statistically significantly different from control values. No effects on globulins were seen in oral studies in dogs or monkeys in the limited number of specimens collected.
Twenty-seven NSAIDs, administered concomitantly with lomefloxacin, were tested for seizure induction in mice at approximately 2 times the recommended human dose based on mg/m2. At a dose of lomefloxacin equivalent to the recommended human exposure based on mg/m2 (10 times the human dose based on mg/kg), only fenbufen, when coadministered, produced an increase in seizures.
Crystalluria and ocular toxicity, seen with some related quinolones, were not observed in any lomefloxacin-treated animals, either in studies designed to look for these effects specifically or in subchronic and chronic toxicity studies in rats, dogs, and monkeys.
Long-term, high-dose systemic use of other quinolones in experimental animals has caused lenticular opacities; however, this finding was not observed with lomefloxacin.
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