Zithromax

[Azithromycin]

Drug Interactions

Aluminum-and magnesium-containing antacids reduce the peak serum levels (rate) but not the AUC (extent) of azithromycin (500 mg) absorption.

Administration of cimetidine (800 mg) two hours prior to azithromycin had no effect on azithromycin (500 mg) absorption. A single oral dose of 1200 mg azithromycin (2 x 600 mg ZITHROMAX tablets) did not alter the pharmacokinetics of a single 800 mg oral dose of fluconazole in healthy adult subjects. Total exposure (AUC) and half-life of azithromycin following the single oral tablet dose of 1200 mg were unchanged and the reduction in Cmax was not significant (mean decrease of 18%) by coadministration with 800 mg fluconazole. A single oral dose of 1200 mg azithromycin (2 x 600 mg ZITHROMAX tablets) had no significant effect on the pharmacokinetics of indinavir (800 mg indinavir tid for 5 days) in healthy adult subjects.

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Coadministration of a single oral dose of 1200 mg azithromycin (2 x 600 mg ZITHROMAX tablets) with steady-state nelfinavir (750 mg tid) to healthy adult subjects produced a decrease of approximately 15% in mean AUC0-8 of nelfinavir and its M8 metabolite. Mean Cmax of nelfinavir and its M8 metabolite were not significantly affected. No dosage adjustment of nelfinavir is required when nelfinavir is coadministered with azithromycin.

Coadministration of nelfinavir (750 mg tid) at steady state with a single oral dose of 1200 mg azithromycin increased the mean AUC0- of azithromycin by approximately a factor of 2-times (range of up to 4 times) of that when azithromycin was given alone. The mean Cmax of azithromycin was also increased by approximately a factor of 2-times (range of up to 5 times) of that when azithromycin was given alone. Dose adjustment of azithromycin is not recommended. However, when administered in conjunction with nelfinavir, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (See ADVERSE REACTIONS.)

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