Extended release amoxicillin/clavulanate: optimizing a product for respiratory infections based on pharmacodynamic principles

Abstract

Acute bacterial respiratory tract infections cause a great deal of human morbidity and mortality. Treatment guidelines for these infections include macrolides, doxycycline, β-lactams and β-lactam/β-lactamase inhibitor combinations such as amoxicillin/clavulanic acid to provide coverage for the common respiratory pathogens, including penicillin and macrolide nonsusceptible Streptococcus pneumoniae, as well as β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis. In response to recent guidelines recommending higher dose amoxicillin to extend coverage to a higher percentage of S. pneumoniae, a new formulation of amoxicillin/clavulanic acid was developed. This formulation includes a higher amoxicillin dose, with part of the amoxicillin dose being in an extended release formulation, without increasing the clavulanate dose, for twice-daily oral treatment of these infections. Clinical studies of community-acquired pneumonia and acute rhinosinusitis have shown that the new formulation is well tolerated and highly efficacious, with clinical outcomes equivalent to comparators.

Keywords::

• acute bacterial rhinosinusitis
• amoxicillin/clavulanic acid
• β-lactam/β-lactamase inhibitor
• community-acquired pneumonia
• drug resistance
• Haemophilus influenzae
• Moraxella catarrhalis
• respiratory infections
• Streptococcus pneumoniae