PMID- 11975700 OWN - NLM STAT- MEDLINE DCOM- 20020910 LR - 20191025 IS - 0269-4727 (Print) IS - 0269-4727 (Linking) VI - 27 IP - 2 DP - 2002 Apr TI - Penetration of levofloxacin into skin tissue after oral administration of multiple 750 mg once-daily doses. PG - 143-50 AB - 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. METHOD: 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. CONCLUSION: The results support the clinical usage of levofloxacin 750 mg once-daily for complicated SSSIs. FAU - Chow, A T AU - Chow AT AD - Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ 08869-0602, USA. achow@prdus.jnj.com FAU - Chen, A AU - Chen A FAU - Lattime, H AU - Lattime H FAU - Morgan, N AU - Morgan N FAU - Wong, F AU - Wong F FAU - Fowler, C AU - Fowler C FAU - Williams, R R AU - Williams RR LA - eng PT - Clinical Trial PT - Journal Article PL - England TA - J Clin Pharm Ther JT - Journal of clinical pharmacy and therapeutics JID - 8704308 RN - 0 (Anti-Infective Agents) RN - 6GNT3Y5LMF (Levofloxacin) RN - A4P49JAZ9H (Ofloxacin) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Anti-Infective Agents/administration & dosage/*pharmacokinetics MH - Female MH - Humans MH - *Levofloxacin MH - Male MH - Middle Aged MH - Ofloxacin/administration & dosage/*pharmacokinetics MH - Skin/chemistry MH - Skin Diseases/*drug therapy MH - Tissue Distribution EDAT- 2002/04/27 10:00 MHDA- 2002/09/11 10:01 CRDT- 2002/04/27 10:00 PHST- 2002/04/27 10:00 [pubmed] PHST- 2002/09/11 10:01 [medline] PHST- 2002/04/27 10:00 [entrez] AID - 396 [pii] AID - 10.1046/j.1365-2710.2002.00396.x [doi] PST - ppublish SO - J Clin Pharm Ther. 2002 Apr;27(2):143-50. doi: 10.1046/j.1365-2710.2002.00396.x.