IngentaConnect Amoxicillin/Clavulanic Acid 2000mg/125mg Extended Release (XR): A...

Abstract:

Amoxicillin/clavulanic acid 2000mg/125mg extended release (Augmentin XR™), referred to herein as amoxicillin/clavulanic acid XR, is a pharmacokinetically enhanced formulation designed to provide more effective therapy in adults and adolescents than conventional formulations against community-acquired respiratory tract pathogens, particularly Streptococcus pneumoniae, with reduced susceptibility to amoxicillin.

Amoxicillin/clavulanic acid XR maintains plasma amoxicillin concentrations above 4 µg/mL for a mean of 49% of the dosing interval indicating that it would be highly effective against S. pneumoniae strains with minimum inhibitory concentrations (MICs) above the National Committee for Clinical Laboratory Standard's amoxicillin ± clavulanic acid susceptibility breakpoint of

2 µg/mL. Amoxicillin/clavulanic acid XR is at least as effective as conventional amoxicillin/clavulanic acid formulations, levofloxacin and clarithromycin in treating community-acquired pneumonia, acute bacterial sinusitis or acute exacerbations of chronic bronchitis, and has a tolerability profile comparable to that of conventional amoxicillin/clavulanic acid formulations. While the incidence of amoxicillin- or multidrug-resistant S. pneumoniae is not currently sufficient in most regions to warrant the routine empirical use of amoxicillin/clavulanic acid XR, the drug would be extremely useful in those regions with a high incidence of resistant pathogens or in selected patients (i.e. those with S. pneumoniae isolates having amoxicillin MICs

2 µg/mL but

4 µg/mL).

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Amoxicillin/Clavulanic Acid 2000mg/125mg Extended Release (XR): A Review of its Use in the Treatment of Respiratory Tract Infections in Adults