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JAC Advance Access originally published online on October 20, 2007
Journal of Antimicrobial Chemotherapy 2007 60(6):1398-1401; doi:10.1093/jac/dkm393
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© The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Elevated gatifloxacin and reduced rifampicin concentrations in a single-dose interaction study amongst healthy volunteers

Helen McIlleron1,*, Jennifer Norman1, Thomas P. Kanyok2, P. Bernard Fourie3, John Horton4 and Peter J. Smith1

1 Division of Clinical Pharmacology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, South Africa 2 Tropical Diseases, Special Programme for Research and Training, World Health Organization, Geneva, Switzerland 3 Medicine in Need, Cambridge, MA, USA 4 Tropical Projects, Hitchin, UK

Received 8 August 2007; returned 7 September 2007; revised 21 September 2007; accepted 22 September 2007

* Corresponding author. Tel: +27-21-406-6292; Fax: +27-21-448-1989; E-mail: helen.mcilleron{at}uct.ac.za

Objectives: Pharmacokinetic drug–drug interactions were investigated between the fluoroquinolone gatifloxacin and a fixed dose combination (FDC) of rifampicin, isoniazid and pyrazinamide.

Patients and methods: The single-dose pharmacokinetics of the four drugs was evaluated in an open-label three-way cross-over study amongst 22 healthy volunteers following administration of gatifloxacin, the FDC or the two products together.

Results: Modest but potentially important drug–drug interactions affecting gatifloxacin and rifampicin concentrations were detected. The elimination rate of gatifloxacin was reduced such that the AUC from 0 h to infinity was increased with a geometric mean ratio (GMR) [90% confidence interval (CI)] of 1.14 (1.10, 1.18). Conversely, the AUC from 0 h to infinity for rifampicin was reduced (GMR: 0.81, 90% CI: 0.81, 0.96) when rifampicin, isoniazid and pyrazinamide were given together with gatifloxacin.

Conclusions: Studies in patients including pharmacokinetic evaluation at steady state, efficacy and toxicity are required to determine the importance of the interactions for use of the combination of gatifloxacin, rifampicin, isoniazid and pyrazinamide in the treatment of tuberculosis.

Keywords: pharmacokinetics , pyrazinamide , isoniazid , Mycobacterium tuberculosis


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