A double-blind placebo-controlled study was conducted in healthy men t
o determine the effect of coadministration of azithromycin on the phar
macodynamics and pharmacokinetics of terfenadine. Administration of 50
0 mg azithromycin for 1 day and 250 mg on 4 subsequent days did not af
fect the pharmacokinetics of the pharmacologically active terfenadine
carboxylate metabolite when 60 mg terfenadine was given twice daily fo
r 12 days, starting 7 days before azithromycin administration. Terfena
dine alone resulted in a 0.010 msec increase in the rate-corrected QT
interval (QT(c)), but the incremental effects of azithromycin and plac
ebo on QT(c) in volunteers receiving terfenadine were not statisticall
y different. It is concluded that the potentially life-threatening dis
orders that have been attributed to a pharmacokinetic interaction betw
een macrolide antibiotics and terfenadine are unlikely to take place i
n patients treated simultaneously with azithromycin and terfenadine.