AUGMENTIN SUMMARY

AUGMENTIN ®

(amoxicillin/clavulanate potassium)
Tablets

AUGMENTIN is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the (beta)-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.

AUGMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections -caused by (beta)-lactamase-producing strains of H. influenzae andM. catarrhalis.

Otitis Media -caused by (beta)-lactamase-producing strains of H. influenzae and M. catarrhalis.

Sinusitis -caused by (beta)-lactamase-producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections -caused by (beta)-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp.

Urinary Tract Infections -caused by (beta)-lactamase-producing strains of E. coli, lebsiella spp. and Enterobacter spp.

While AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and (beta)-lactamase-producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and AUGMENTIN. (See Microbiology.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Bacteriological studies, to determine the causative organisms and their susceptibility to AUGMENTIN, should be performed together with any indicated surgical procedures.