Effect of single doses of rufloxacin on the disposition of theophylline and caffeine after single administration.

Several reports indicate that quinolone antibiotics affect the pharmacokinetics of theophylline and caffeine. This study investigated the effects of one single oral dose of rufloxacin, a new quinolone antibacterial, on the pharmacokinetics of theophylline and caffeine, given as single oral doses. Twelve healthy male volunteers were randomly given one of the following treatments: treatment T: 300 mg theophylline; treatment T + R: 300 mg theophylline followed by 400 mg rufloxacin after 30 min; treatment C: 200 mg caffeine; treatment C + R: 200 mg caffeine followed by 400 mg rufloxacin after 30 min. Blood samples for determination of xanthine plasma levels were taken immediately before and 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours after xanthine administration. Urine were collected before treatment and at 0-6, 6-12, 12-24 and 24-48 h intervals. There were no significant differences in the pharmacokinetic parameters or in urinary excretion after administration of either theophylline or caffeine when combined with rufloxacin. Sleep disturbances were reported by two subjects after both treatment T + R and C + R, and by four subjects after treatment T + R. The results of this study indicate that there is no significant pharmacokinetic interaction between a single oral dose of rufloxacin and single doses of theophylline and caffeine.

RCT Entities:   Population Interventions Outcomes