GlaxoSmithKline (GSK) 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).
Augmentin XR is indicated for the treatment of patients with ABS or CAP confirmed or suspected to be caused by b-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).
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).
In recent years, common bacteria such as S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis that cause respiratory tract infections like ABS and CAP have become increasingly resistant to antibiotics. Antibiotic resistance occurs when bacteria change in different ways that reduce or eliminate the effectiveness of drugs, chemicals or other agents designed to cure or prevent infections. The surviving bacteria continue to multiply in the body, possibly causing more harm. Widespread use of antibiotics promotes the spread of antibiotic resistance. According to the U.S. Centres for Disease Control and Prevention, antibiotic resistance is a serious public health problem.
"With Augmentin XR, GlaxoSmithKline has responded to a medical need for antibiotics that continue to be effective in this era of evolving drug resistance," said Brian Lortie, Vice President, Anti-Infectives, GlaxoSmithKline. "We are proud to offer physicians a powerful new tool to help them with this emerging public health problem."