Clarithromycin Extended-Release Tablet

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Am J Respir Med 2003; 2 (2): 175-201 1175-6365/03/0002-0175/$30.00/0 © Adis Data Information BV 2003. All rights reserved.

Clarithromycin Extended-Release Tablet A Review of its Use in the Management of Respiratory Tract Infections Malcolm J.M. Darkes and Caroline M. Perry Adis International Inc., Langhorne, Pennsylvania, USA Various sections of the manuscript reviewed by: M.R. Jacobs, Department of Pathology, Case Western Reserve University and University Hospitals of Cleveland, Cleveland, Ohio, USA; J.J. Murray, Allergy and Asthma Research Center, Vanderbilt Medical Center, Nashville, Tennessee, USA; H.S. Sader, Division of Infectious Diseases, Federal University of Sao Paulo, Sao Paulo, Brazil; C.J. van Boxtel, Department of Clinical Pharmacology and Pharmacotherapy, Academic Medical Centre, Amsterdam, The Netherlands.

Data Selection Sources: Medical literature published in any language since 1980 on clarithromycin, identified using Medline, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug. Search strategy: Medline search terms were ‘clarithromycin’ and ‘extended release’. AdisBase search terms were ‘clarithromycin’ and ‘extended release’. Searches were last updated March 24th 2003. Selection: Studies in patients with respiratory tract infection who received clarithromycin. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: Clarithromycin, pharmacodynamics, pharmacokinetics, therapeutic use.

Contents Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 2. Pharmacodynamic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179 2.1 Mechanism of Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179 2.2 Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 2.3 In Vitro Antibacterial Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . .