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Journal of Antimicrobial Chemotherapy (1999) 43, 733-736
© 1999 The British Society for Antimicrobial Chemotherapy

Brief report

Lack of effect of dirithromycin on theophylline pharmacokinetics in healthy volunteers

Scott A. McConnella, Anne N. Nafzigerb,c and Guy W. Amsdena,b,c,*

a Department of Pharmacy Services, Clinical Pharmacology Research Center, Bassett Healthcare, 1 Atwell Road, Cooperstown, NY 13326-1394, USA; b Department of Medicine, Clinical Pharmacology Research Center, Bassett Healthcare, 1 Atwell Road, Cooperstown, NY 13326-1394, USA; c Clinical Pharmacology Research Center, Bassett Healthcare, 1 Atwell Road, Cooperstown, NY 13326-1394, USA

Twelve healthy volunteers were enrolled in an open-label, randomized, crossover study. Subjects received single doses of theophylline (5 mg/kg) alone and after a 10 day course of dirithromycin (two 250 mg tablets od). The study phases were separated by a 3 week washout period. Serum samples were collected before and for 24 h after theophylline doses. Serum theophylline concentrations were measured via a validated immunoassay system and the data were modelled via non-compartmental analysis. When the control phase (i.e. no dirithromycin) was compared with the treatment phase (i.e. with dirithromycin), theophylline exposures as measured by AUC0->{infty} were not significantly different: 141.7 ± 25.9 and 136.4 ± 33.1 mg · h/L respectively (P=0.16). No significant changes in other theophylline pharmacokinetic parameters were evident. These results indicate that theophylline can be safely co-administered with dirithromycin.

* Corresponding author. Tel: +1-607-547-3399; Fax: +0-607-547-6914; E-mail: guy.amsden{at}bassett.org


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