New Insights on the Pharmacokinetics of Ulifloxacin After Administration of Prulifloxacin in Patients with Mild, Moderate and Severe Renal Impairment

Drugs in R&D
Valeria TelloneSerena Tongiani

Abstract

The antibacterial agent prulifloxacin, a prodrug of ulifloxacin, is indicated in the treatment of acute lower urinary tract infections, acute exacerbation of chronic bronchitis and acute bacterial rhinosinusitis. We aimed to provide new insights on the pharmacokinetics (PK) of ulifloxacin in patients with different degrees of renal impairment. A two-site, international, open-label, parallel-group, single- and repeated-dose study was performed. The drug was administered as a single dose of 600 mg to subjects with normal renal function and patients with mild, moderate and severe renal impairment. Subsequently, the same dose was administered daily for 7 days to subjects with normal renal function and patients with mild and moderate renal impairment, while a dose of 300 mg was administered daily for 7 days to patients with severe renal impairment. Plasma and urine ulifloxacin levels were measured. Complete safety evaluation was performed. Exposure to ulifloxacin increased as renal function decreased due to a lower ulifloxacin clearance. Ulifloxacin PK were significantly changed only in patients with severe renal impairment. The amount of ulifloxacin excreted in urine over a 24-h dosing period was similar in subjects with normal ren...Continue Reading

References

Sep 1, 1994·Journal of Clinical Pharmacology·M NakashimaY Takebe
Jul 13, 2002·The American Journal of Medicine·Betsy Foxman
Oct 1, 2004·Drugs·Susan J Keam, Caroline M Perry
Feb 9, 2011·International Journal of Antimicrobial Agents·Petros I RafailidisMatthew E Falagas
Aug 11, 2012·American Journal of Respiratory and Critical Care Medicine·Jørgen VestboRoberto Rodriguez-Roisin

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Citations

Dec 9, 2020·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·Suzanne L de VroomSuzanne E Geerlings

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Software Mentioned

SAS
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