STAHLBERG HJ, GOHLER K, LECLERC V, MIGNOT A; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 11 (abstract no. 195).
Grunenthal GmbH, Aachen, GERMANY
Gatifloxacin (CG5501, GTX) is a new fluoroquinolone with a broad spectrum of activity against gram positive and gram negative bacteria. Along with other indications GTX is being developed for the treatment of respiratory tract infections. In healthy subjects up to 90% of a GTX does is excreted renally. Thus renal impairment should affect the PK of GTX. Therefore single dose PK of GTX was evaluated in 6 groups with selected degrees of renal impairment: 1) CLCR >/= 90 ml/min, normal (n=8), 2) CLCR 50 - 90 ml/min, mild (n=10), 3) CLCR 30 - 50 ml/min, moderate (n=8), 4) CLCR < 30 ml/min, severe (n=8), 5) anuric subjects with haemodialysis and 6) anuric patients undergoing CAPD. Those subjects not on dialysis received a single 400 mg does of GTX while the subjects in the haemodialysis group received single 400 mg doses of GTX on two different days, seperated by a wash-out period of at least 10 days. Single oral doses of 400 mg GTX were well tolerated in all subjects. There was no obvious relationship between TMAX, CMAX or VDBeta/F and CLCR, while UAC and T-HALF increased with decreased renal function. A direct linear relationship exists between CLT/F or CLR and CLCR. In subjects with severe renal impairment nearly a 4-fold reduction in CLT/F was observed compared to the normal renal function group. Approximately 14% and 11% of the administered dose was removed by a 4 h haemodialysis session or by peritoneal dialysis over an eight day period, respectively. In patients with severe renal impairment (CLCR < 30 ml/min) a GTX dosing modification is recommended. 400 mg GTX should be administered as a single initial dose on day 1 followed by 200 mg doses of GTX o. d. on day 2 and every following day.
Publication Types:
Keywords:
- Fluoroquinolones
- Humans
- Kidney Diseases
- Peritoneal Dialysis, Continuous Ambulatory
- Renal Dialysis
- Safety
- Ureteral Diseases
- gatifloxacin
- pharmacokinetics
Other ID:
UI: 102244723
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