19659
document
A randomized crossover study investigating the influence of ranitidine or omeprazole on the pharmacokinetics of cephalexin monohydrate . Limited data characterize pharmacokinetic interactions between cephalexin and ranitidine , and no data exist for an interaction with proton pump inhibitors . The purpose of this study was to investigate the effects of ranitidine or omeprazole administration on the pharmacokinetics and pharmacodynamics of cephalexin . A randomized single- and multiple-dose crossover study was conducted in healthy subjects ingesting cephalexin before and after steady-state administration of ranitidine or omeprazole . Time-concentration profiles were determined and pharmacokinetic parameters were characterized using noncompartmental methods . Pharmacokinetic data were analyzed in accordance with the two 1-sided test for bioequivalence . The percentage of time that serum concentrations remain above the MIC ( 90 ) during the dosing interval ( T > MIC ( 90 ) ) for Streptococcus pyogenes and Staphylococcus aureus associated with the pharmacokinetic profiles was calculated . The coadministration of cephalexin with ranitidine or omeprazole resulted in relatively minor changes in C ( max ) , AUC ( infinity ) , t ( 1/2 ) , or CL/F . t ( max ) was significantly prolonged when cephalexin was administered with ranitidine or omeprazole . Suboptimal T > MIC ( 90 ) was observed for cephalexin irrespective of acid suppression . Delay in absorption of cephalexin resulted in a decrease in the percentage of T > MIC ( 90 ) for certain acid-suppressive regimens and pathogen combinations . With the exception of an increase in t ( max ) , there were no significant pharmacokinetic interactions between cephalexin and ranitidine or omeprazole . Delayed t ( max ) associated with acid suppression may result in a diminished T > MIC ( 90 ) .
19660
Intervention_Pharmacological
ranitidine
19661
Intervention_Pharmacological
omeprazole
19662
Intervention_Pharmacological
ranitidine
19663
Intervention_Pharmacological
omeprazole
19664
Intervention_Pharmacological
cephalexin
19665
Intervention_Pharmacological
cephalexin
19666
Intervention_Pharmacological
ranitidine
19667
Intervention_Pharmacological
omeprazole
19668
Outcome_Physical
pharmacokinetics of cephalexin monohydrate .
19669
Outcome_Physical
pharmacokinetics and pharmacodynamics of cephalexin
19670
Outcome_Other
Time-concentration
19671
Outcome_Physical
pharmacokinetic parameters
19672
Outcome_Physical
percentage of time that serum concentrations remain above the MIC ( 90 ) during the dosing interval ( T > MIC ( 90 ) )
19673
Outcome_Physical
Streptococcus pyogenes
19674
Outcome_Other
C ( max )
19675
Outcome_Physical
,
19676
Outcome_Other
AUC ( infinity )
19677
Outcome_Physical
,
19678
Outcome_Other
t ( 1/2 )
19679
Outcome_Physical
, or
19680
Outcome_Other
CL/F
19681
Outcome_Physical
t ( max )
19682
Outcome_Physical
Suboptimal T > MIC ( 90 )
19683
Outcome_Physical
T > MIC ( 90 )
19684
Outcome_Physical
t ( max )
19685
Outcome_Physical
t ( max )
19686
Participant_Condition
healthy subjects ingesting cephalexin