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Augmentin

Clinical Pharmacology
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Clinical Pharmacology

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-mcg amoxicillin/clavulanate acid (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should be interpreted according to the following criteria: RECOMMENDED RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING

For Staphylococcus‡ ‡ species and H. influenzaea:

Zone Diameter (mm) Interpretation
≥ 20 Susceptible (S)
≤ 19 Resistant (R)
‡ ‡ Staphylococci which are resistant to methicillin/oxacillin must be considered as resistant to amoxicillin/clavulanic acid.
a A broth microdilution method should be used for testing H. influenzae. Beta-lactamase–negative, ampicillin-resistant strains must be considered resistant to amoxicillin/clavulanic acid.

For Other Organisms Except S. pneumoniaeb and N. gonorrhoeaec:

Zone Diameter (mm) Interpretation
≥ 18 Susceptible(S)
14 to 17 Intermediate(I)
≤ 13 Resistant(R)
b Susceptibility of S. pneumoniae should be determined using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin/clavulanic acid. An amoxicillin/clavulanic acid MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm.
c A broth microdilution method should be used for testing N. gonorrhoeae and interpreted according to penicillin breakpoints.


Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for amoxicillin/clavulanic acid.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-mcg amoxicillin/clavulanate potassium (20-mcg amoxicillin plus 10-mcg clavulanate potassium) disk should provide the following zone diameters in these laboratory quality control strains:

Microorganism Zone Diameter (mm)
Escherichia coli ATCC 25922 19 to 25
Escherichia coli ATCC 35218 18 to 22
Staphylococcus aureus ATCC 25923 28 to 36

Clinical Studies

Data from 2 pivotal studies in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875-mg tablets of AUGMENTIN q12h to 500-mg tablets of AUGMENTIN dosed q8h (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the q12h and q8h dosing regimens. There was no significant difference in the percentage of adverse events in each group. The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875-mg q12h and 500-mg q8h dosing regimens (14.9% and 14.3%, respectively); however, there was a statistically significant difference (p < 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1.0% for 875-mg q12h dosing versus 2.5% for the 500-mg q8h dosing.

Brand Name: Augmentin
Generic Name: Amoxicillin Clavulanate
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