Augmentin - Indications & Dosage

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As noted before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically— Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. NCCLS, Villanova, PA, December 1993.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests— Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24. NCCLS, Villanova, PA, December 1993.

3. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol 1988; 30: 66-67.

DATE OF ISSUANCE MAY 2002

©2002, GlaxoSmithKline All rights reserved.

GlaxoSmithKline Research Triangle Park, NC 27709

AG: AL10

INDICATIONS AND USAGE

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 -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Otitis Media– caused by -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Sinusitis– caused by -lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Skin and Skin Structure Infections– caused by -lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.

Urinary Tract Infections– caused by -lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.

While Augmentin is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to Augmentin treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and -lactamase-producing organisms susceptible to Augmentin should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against Streptococcus 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 subsection.)