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Journal of Antimicrobial Chemotherapy (1994) 33, 795-801
© 1994 The British Society for Antimicrobial Chemotherapy


other

Comparative pharmacokinetics and safety of ciprofloxacin 400 mg iv thrice daily versus 750 mg po twice daily

A. Shah, J. Lettieri, L. Kaiser, R. Echols and A. H. Heller

Miles Inc., Pharmaceutical Division 400 Morgan Lane, West Haven, Connecticut 06516, USA

Received 2 September 1993; accepted 20 November 1993


Comparative pharmacokinetics of iv and oral ciprofloxacin was studied in 24 healthy male subjects given 400 mg iv tds or 750 mg po bd in a randomized, doubleblind, placebo controlled, crossover fashion with at least a 10 day washout period. Blood and urine samples were obtained following the first (single dose) and last (steady state) dose in each treatment period. After single dosing and under steady state conditions, the calculated 24 h area under the serum concentration versus time curve, (AUC0–24) after 400 mg iv tds (AUC0–8 x 3) was equivalent to the AUC0–24 after 750 mg po bd (AUC0–12 x 2). Peak serum concentrations produced by the iv regimen were very similar to those observed after the 750 mg oral dose. The extent of accumulation was similar following either dosing regimen and was approximately 35%. Overall, the incidence of adverse effects (none of which was serious) was higher with the iv regimen than with the oral regimen, mainly due to injection site reaction, which was the most commonly reported adverse event.


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