Augmentin

[Amoxicillin/Clavulanate]

Clinical Pharmacology
CLINICAL PHARMACOLOGY

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Augmentin. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While Augmentin can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state.

In one study, the relative bioavailability of clavulanate was reduced when Augmentin was dosed at 30 and 150 minutes after the start of a high fat breakfast. The safety and efficacy of Augmentin have been established in clinical trials where Augmentin was taken without regard to meals.

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Mean * amoxicillin and clavulanate potassium pharmacokinetic parameters are shown in the table below:
Dose * and regimen AUC0-24 (µg. hr/ mL) Cmax (µg/ mL) amoxicillin/
clavulanate potassium amoxicillin (± S. D.) clavulanate potassium (± S. D.) amoxicillin (± S. D.) clavulanate potassium (± S. D.)
250/ 125 mg q8h 26.7 ± 4.56 12.6 ± 3.25 3.3 ± 1.12 1.5 ± 0.70 500/ 125 mg q12h 33.4 ± 6.76 8.6 ± 1.95 6.5 ± 1.41 1.8 ± 0.61
500/ 125 mg q8h 53.4 ± 8.87 15.7 ± 3.86 7.2 ± 2.26 2.4 ± 0.83 875/ 125 mg q12h 53.5 ± 12.31 10.2 ± 3.04 11.6 ± 2.78 2.2 ± 0.99
* Mean values of 14 normal volunteers (n= 15 for clavulanate potassium in the low-dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose. * Administered at the start of a light meal.

Amoxicillin serum concentrations achieved with Augmentin are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration of Augmentin is 1.3 hours and that of clavulanic acid is 1.0 hour. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single Augmentin 250 mg or 500 mg tablet. Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

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