✦ LIBER ✦

Pharmacokinetics and safety of single oral doses of lomefloxacin

✍ Scribed by Dr. Irwin S. Morse

Publisher: John Wiley and Sons
Year: 1990
Tongue: English
Weight: 444 KB
Volume: 11
Category: Article
ISSN: 0142-2782
DOI: 10.1002/bdd.2510110608

No coin nor oath required. For personal study only.

✦ Synopsis

The pharmacokinetics of 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg of lomefloxacin, a quinolone antimicrobial, were examined in a single sequential rising dose, placebocontrolled, crossover study. Each of 30 healthy male subjects (6 per group) received placebo and one dose of lomefloxacin, separated by 5 days.

Test results (physical examinations, laboratory and hematology panels, vital signs, neurological and ophthalmological examinations, EEG or urinalysis) revealed no clinically significant differences compared to baseline.

Mean C,,, values (0.92 pgml-I to 6.99 pgml-I) increased linearly with dose. Mean t,,, averaged 1.13 f 0.5 h and mean t,, 7.8 f 1.0 h over all doses. There was a small influence of dose on the AUC,,.

Mean urinary concentrations during the first 4 h postdosing ranged from 79 to 454 pgml-I. Urine concentrations remained 3 15 pgm1-I over 24 h at the lowest dose. Maximum urinary excretion rate, R,,,, ranged from 5.84mgh-' to 34.90mg h-'. Dose normalized R,,, and XU,, (per cent of dose) were unaffected by dose. Mean renal clearance decreased at higher doses.

In conclusion, lornefloxacin was well tolerated in doses up to 800 mg. Lomefloxacin is rapidly absorbed with an elimination half-life of approximately 8 h. The data suggest that the drug can be effectively administered once daily.

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