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Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as AUGMENTIN it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.
In the list as follows, organisms are categorised according to their in vitro susceptibility to AUGMENTIN. (See Tables 1 and 2.)
Tablet/Oral suspension: (see Table 1.)
Click on icon to see table/diagram/imageOral suspension: Infections caused by amoxicillin-susceptible organisms are amenable to AUGMENTIN treatment due to its amoxicillin content. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with AUGMENTIN-susceptible beta-lactamase producing organisms may therefore be treated with AUGMENTIN.
Injection: (see Table 2.)
Click on icon to see table/diagram/imagePharmacokinetics: Tablet: The pharmacokinetics of the two components of AUGMENTIN are closely matched. Peak serum levels of both occur about 1 hour after oral administration. Absorption of AUGMENTIN is optimised at the start of a meal.
Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.
Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Oral suspension: Absorption: The two components of AUGMENTIN suspension 228 mg/5 mL and 457 mg/5 mL, amoxicillin and clavulanate, are each fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of AUGMENTIN is optimised when taken at the start of a meal.
The mean AUC values for amoxicillin are essentially the same following twice a day dosing with the AUGMENTIN 875/125 mg tablet or three times a day dosing with the AUGMENTIN 500/125 mg tablet, in adults. No differences between the 875 mg twice daily and 500 mg three times daily dosing regimes are seen when comparing the amoxicillin T½, or Cmax after normalisation for the different doses of amoxicillin administered. Similarly, no differences are seen for the clavulanate T½, Cmax or AUC values after appropriate dose normalisation.
The time of dosing of AUGMENTIN relative to the start of a meal has no marked effects on the pharmacokinetics of amoxicillin in adults. In a study of the AUGMENTIN 875/125 mg tablet, the time of dosing relative to ingestion of a meal had a marked effect on the pharmacokinetics of clavulanate. For clavulanate AUC and Cmax, the highest mean values and smallest inter-subject variabilities were achieved by administering AUGMENTIN at the start of a meal, compared to the fasting state or 30 or 150 minutes after the start of a meal.
The mean Cmax, Tmax, T½ and AUC values for amoxicillin and clavulanate are given as follows for an 875 mg/125 mg dose of amoxicillin/clavulanic acid administered at the start of a meal. (See Table 3.)
Click on icon to see table/diagram/imageAmoxicillin serum concentrations achieved with AUGMENTIN are similar to those produced by the oral administration of equivalent doses of amoxicillin alone.
Distribution: The pharmacokinetics of the two components of AUGMENTIN are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.
Injection: The pharmacokinetics of the two components of AUGMENTIN are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.
Toxicology: Pre-clinical Safety Data: No further information of relevance.
