Penetration of levofloxacin into skin tissue after oral administration of multiple 750 mg once-daily doses.
OBJECTIVE
To probe the pharmacokinetic basis for the use of levofloxacin for complicated skin and skin-structure infections (SSSIs) at a once-daily dosage of 750 mg by investigating its penetration into skin tissue.


METHODS
Ten healthy volunteers were administered three oral, once-daily 750 mg doses of levofloxacin, and levofloxacin concentrations were subsequently measured over time (0.5-24 h) in skin-punch biopsy tissue and plasma.


RESULTS
Skin tissue concentrations consistently exceeded those in plasma at every time point, with tissue/plasma ratios of 1.37 +/- 0.81 for peak concentration and 1.97 +/- 0.35 for area under the concentration versus time curve. Three of the ten subjects reported treatment-emergent adverse events (AEs) that were considered unrelated to treatment. An 11th subject who had enrolled in the study withdrew after AEs of mild severity that were possibly related to the study drug.


CONCLUSIONS
The results support the clinical usage of levofloxacin 750 mg once-daily for complicated SSSIs.
Chow
A T
AT
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ 08869-0602, USA. achow@prdus.jnj.com
Chen
A
A
Lattime
H
H
Morgan
N
N
Wong
F
F
Fowler
C
C
Williams
R R
RR
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012867:Skin / Q000737:chemistry; D012871:Skin Diseases / Q000188:drug therapy*; D014018:Tissue Distribution
D000890:Anti-Infective Agents; D064704:Levofloxacin; D015242:Ofloxacin