Ciprofloxacin Extended Release
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Drugs Aging 2004; 21 (1): 65-66 1170-229X/04/0001-0065/$31.00/0 © 2004 Adis Data Information BV. All rights reserved.
Ciprofloxacin Extended Release
A Viewpoint by George G. Zhanel1 and Ethan Rubinstein2
1 2
Department of Medical Microbiology, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada Infectious Diseases Unit, Sheba Medical Center, Tel Aviv University, School of Medicine, Tel Hashomer, Israel
Ciprofloxacin extended release (XR) is a new oral formulation of ciprofloxacin which has recently been approved in North America and Europe for once daily treatment of uncomplicated urinary tract infections (UTI), complicated UTI and uncomplicated pyelonephritis in adult patients. This new formulation utilises a coated bilayer tablet designed to slow the release of the drug in the intestinal tract compared with the available immediate-release formulation, thus prolonging the absorption period. The layers are composed of different proportions of two ciprofloxacin salts, ciprofloxacin hydrochloride and ciprofloxacin betaine. The first layer releases ≈35% of the dose immediately after oral administration, while the second controlled-release layer releases the remaining 65% at a slower rate. The pharmacokinetics of ciprofloxacin XR 500mg once daily (indicated for uncomplicated UTI) and ciprofloxacin XR 1000mg once daily (indicated for complicated UTI and uncomplicated py-
elonephritis) are similar to immediate-release ciprofloxacin 250 and 500mg twice daily with respect to bioavailability, area under the concentration-time curve over 24 hours and percent renal excretion. However, ciprofloxacin XR 500 and 1000mg once daily display higher maximum concentrations in plasma and longer half-lives when compared with immediate-release ciprofloxacin (≈6.5 vs ≈4 hours). The efficacy of ciprofloxacin XR 500mg once daily for 3 days and ciprofloxacin XR 1000mg once daily for 7–14 days have been compared with immediate-release ciprofloxacin 250mg twice daily for 3 days and 500mg twice daily for 7–14 days, in multicentre, randomised, double-blind trials. These trials have demonstrated that bacteriological eradication and clinical cure rates were not significantly different between the two formulations. They have also concluded that the tolerability of the two ciprofloxacin formulations is similar. In conclusion, ciprofloxacin XR is a new once daily oral formulation of ciprofloxacin that has demonstrated similar efficacy and tolerability compared with immediate-release ciprofloxacin in the treatment of uncomplicated UTI, complicated UTI and uncomplicated pyelonephritis in adults. The advantages of this new formulation over the immediaterelease formulation include enhanced patient convenience and adherence to therapy. ▲
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