GlaxoSmithKline today announced that Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets has received United States Food and Drug Administration (FDA) approval for the treatment of adults with acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP). Specifically, Augmentin XR is indicated for the treatment of patients with ABS or CAP confirmed or suspected to be caused by beta-lactamase-producing bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae (S. pneumoniae) with reduced susceptibility to penicillin (i.e., penicillin MICs* = 2 mcg/mL).
S. pneumoniae with penicillin MIC >/= 2 mcg/mL are considered resistant to penicillin. Augmentin XR employs a unique extended release formulation — bi-layer tablets that provide an immediate release of amoxicillin and clavulanate potassium and an extended release of amoxicillin. This enhanced formulation prolongs the time that the bacterium is exposed to the antibiotic and promotes coverage of tough-to-treat S. pneumoniae. Augmentin XR is the first antibiotic to be approved for the treatment of both ABS and CAP caused by strains of this bacterium with reduced penicillin susceptibility (MIC = 2 mcg/mL).
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