Pharmacology: Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of AMOCLA. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While AMOCLA 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 AMOCLA was dosed at 30 and 150 minutes after the start of a high fat breakfast. The safety and efficacy of AMOCLA have been established in clinical trials where AMOCLA was taken without regard to meals.
Amoxicillin serum concentrations achieved with AMOCLA 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 AMOCLA 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 AMOCLA 625mg tablet.
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
Neither component in AMOCLA is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.
Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.