Extended-Release amoxicillin/clavulanate Formulation, Augmentin XR(reg), Effective for Acute Bacterial Rhinosinusitis (ABRS)

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 20 Aug 2004 - 10:00 PDT

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A specially engineered formulation of amoxicillin/clavulanate, GlaxoSmithKline's Augmentin XR(reg) (amoxicillin/clavulanate potassium) Extended Release Tablets, is effective in treating acute bacterial rhinosinusitis (ABRS), according to a review published in the June issue of Clinics in Laboratory Medicine (vol. 24, pages 531-551). This is despite significant prevalence of resistance to commonly used antimicrobials in bacteria that cause ABRS.

The evolution of amoxicillin/clavulanate in the treatment of adults with ABRS and community-acquired pneumonia (CAP) in response to antimicrobial resistance patterns was reviewed by Michael R. Jacobs, MD, PhD, Thomas M. File, Jr., MD, and Michael S. Benninger, MD.

The review documented the evolution of drug therapies in the treatment of ABRS and CAP and highlighted that although the common bacteria causing ABRS and CAP have become resistant to many current antibiotics, Augmentin XR proves to be safe and effective in treating adults with ABRS and CAP, including patients infected with some types of antibioticresistant organisms. Annually, the United States healthcare system sees ABRS and CAP as two of the most common respiratory tract infections.

"In today's environment of resistant pathogens and empiric practices, it is particularly important to provide patients with effective treatments to cure the infection, while limiting use of our most powerful agents to preserve their activity," said Michael R. Jacobs, MD, PhD, Professor, Department of Pathology, Case Western Reserve University and University Hospitals of Cleveland, Cleveland, Ohio, and an author of the review. "Augmentin XR is an important development because it has sustained efficacy with a safety and tolerability profile similar to older formulations of Augmentin(reg). It is also a recommended option in evidence-based third party guidelines for ABRS treatment for patients with risk factors for infection with resistant pathogens, such as recent use of antibiotics."

The pharmacokinetically enhanced formulation of amoxicillin/clavulanate provides an immediate release of amoxicillin/clavulanate and an extended release of amoxicillin, which proves effective in the treatment of ABRS.

The review found the distinctive combination prolongs the exposure of bacteria to the antibiotic and promotes the coverage of resistant strains of Streptococcus pneumoniae, specifically S. pneumoniae with penicillin MIC = 2 ug/mL.

Approximately 20 million cases of ABRS are reported each year in the United States, and treatment of the infections costs the United States economy nearly $3.5 billion annually. Due to increased use of antimicrobial agents, resistance to antibiotics is on the rise. In particular, many older antibiotics have become ineffective in treating ABRS, because antibiotic resistance has developed or increased, especially among Streptococcus pneumoniae and Haemophilus influenzae, the two bacteria that cause up to 78 percent of cases of ABRS in adults.

"Augmentin XR was well tolerated and efficacious in clinical trials in which more than 4,000 patients received Augmentin XR," said Betsy Abraham-Van Parijs, MD, PhD, Senior Director of Clinical Development at GlaxoSmithKline. "In light of today's current resistance patterns, Augmentin XR is proven to be a highly effective treatment option physicians can count on."

About the Review

The review, titled "Evolution of amoxicillin/clavulanate in the treatment of adults with acute bacterial rhinosinusitis and community-acquired pneumonia in response to antimicrobial-resistance patterns," was published in the June issue of Clinics in Laboratory Medicine. The review examined the timeline of �-lactam discovery (penicillin), the development of antimicrobial resistance, and the rationale for a new enhanced formulation of amoxicillin/clavulanate (Augmentin XR) in the treatment of ABRS and CAP. The continued efficacy of amoxicillin/clavulanate despite the growing bacterial resistance to �-lactam was reviewed.

About Augmentin XR

Augmentin XR, which became available in 2002, is an extended release formulation that is indicated for patients 16 years or older with acute bacterial sinusitis or community-acquired pneumonia due to confirmed or suspected �-lactamase-producing pathogens, such as H. influenzae or M. catarrhalis, and S. pneumoniae with reduced susceptibility to penicillin (penicillin MIC = 2 ug/mL). Augmentin XR is not indicated for the treatment of infections due to S. pneumoniae with penicillin MIC ��4 ug/mL. Augmentin XR is contraindicated in patients with a history of allergic reactions to any penicillin or cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium, in patients with severe renal impairment (creatinine clearance < 30 mL/min), and in hemodialysis patients. Please go to http://www.gsk.com or call 1-888-825-5249 to see more complete prescribing information for Augmentin XR for contraindications, warnings, precautions, adverse reactions, dosage and administration.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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GlaxoSmithKline Cohn & Wolfe
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