Document Detail


Absence of age and gender effects on the pharmacokinetics of a single 500-milligram oral dose of levofloxacin in healthy subjects.
MedLine Citation:
PMID:  9210685     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The influence of age and gender on the pharmacokinetics of levofloxacin in healthy subjects receiving a single oral 500-mg dose of levofloxacin was investigated in this parallel design study. Six young males (aged 18 to 40 years), six elderly males (aged > or = 65 years), six young females (aged 18 to 40 years), and six elderly females (aged > or = 65 years) were enrolled and completed the study. The study reveals that the bioavailability (rate and extent) of levofloxacin was not affected by either age or gender. In both age (young and elderly) and gender (male and female) groups of subjects, peak concentrations in plasma were reached at approximately 1.5 h after dosing; renal clearance of levofloxacin accounted for approximately 77% of total body clearance, and approximately 76% of the administered dose was recovered unchanged in urine over the 36 h of collection. The apparent differences in the calculated pharmacokinetic parameters for levofloxacin between the age groups (young versus elderly) and between the gender groups (males versus females) could be explained by differences in renal function among the subjects. A single dose of 500 mg of levofloxacin administered orally to both young and old, male and female healthy subjects was found to be safe and well tolerated. As the differences in levofloxacin kinetics between the young and the elderly or the males and the females are limited and are mainly related to the renal function of the subjects, dose adjustment based on age or gender alone is not necessary.
Authors:
S C Chien; A T Chow; J Natarajan; R R Williams; F A Wong; M C Rogge; R K Nayak
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  41     ISSN:  0066-4804     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  1997 Jul 
Date Detail:
Created Date:  1997-09-12     Completed Date:  1997-09-12     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1562-5     Citation Subset:  IM    
Affiliation:
The R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Aged, 80 and over
Aging / metabolism*
Anti-Infective Agents / administration & dosage,  adverse effects,  pharmacokinetics*
Female
Humans
Male
Metabolic Clearance Rate
Ofloxacin / administration & dosage,  adverse effects,  pharmacokinetics*
Reference Values
Sex Characteristics*
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 82419-36-1/Ofloxacin
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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