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Antimicrobial Agents and Chemotherapy, May 1999, p. 1152-1155, Vol. 43, No. 5
0066-4804/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Lack of Effect of Zafirlukast on the Pharmacokinetics of Azithromycin, Clarithromycin, and 14-Hydroxyclarithromycin in Healthy Volunteers

Kevin W. Garey,1,2 Charles A. Peloquin,3 Paul G. Godo,3 Anne N. Nafziger,2,4 and Guy W. Amsden1,2,4,*

Departments of Pharmacy1 and Medicine2 and the Clinical Pharmacology Research Center,4 Bassett Healthcare, Cooperstown, New York, and the Infectious Diseases Pharmacokinetics Laboratory,3 National Jewish Medical and Research Center, Denver, Colorado

Received 23 June 1998/Returned for modification 1 November 1998/Accepted 6 March 1999

This randomized, open-label, crossover study was conducted to investigate whether the coadministration of zafirlukast would affect the pharmacokinetics of azithromycin, clarithromycin, or 14-hydroxyclarithromycin (14-OHC). Twelve healthy subjects (six males and six females) received single 500-mg doses of azithromycin and clarithromycin with and without zafirlukast given to a steady-state concentration. Blood was collected prior to all macrolide doses and for 3 and 10 days after each clarithromycin and azithromycin dose, respectively. Serum was assayed for azithromycin, clarithromycin, and 14-OHC concentrations by validated high-performance liquid chromatography assay systems. Data analyses were done by noncompartmental and nonparametric methods. Analysis of the patients indicated that the addition of steady-state concentrations of zafirlukast did not significantly alter the pharmacokinetic parameters of or overall exposure (based on the area under the concentration-time curve) to azithromycin, clarithromycin, and 14-OHC. While zafirlukast is a known inhibitor of CYP3A4, it does not appear to exert a clinically or statistically significant pharmacokinetic effect on azithromycin, clarithromycin, or 14-OHC.

* Corresponding author. Mailing address: Clinical Pharmacology Research Center, Bassett Healthcare, 1 Atwell Rd., Cooperstown, NY 13326. Phone: (607) 547-3399. Fax: (607) 547-6914. E-mail: guy.amsden{at}bassett.org.

Antimicrobial Agents and Chemotherapy, May 1999, p. 1152-1155, Vol. 43, No. 5
0066-4804/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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