Commonly susceptible species
 
Aerobic Gram-positive micro-organisms

Enterococcus faecalis

Gardnerella vaginalis

Staphylococcus aureus (methicillin-susceptible)£

Coagulase-negative staphylococci (methicillin-susceptible)

Streptococcus agalactiae

Streptococcus pneumoniae1

Streptococcus pyogenes and other beta-haemolytic streptococci

Streptococcus viridans group

Aerobic Gram-negative micro-organisms

Capnocytophaga spp.

Eikenella corrodens

Haemophilus influenzae2

Moraxella catarrhalis

Pasteurella multocida

Anaerobic micro-organisms

Bacteroides fragilis

Fusobacterium nucleatum

Prevotella spp.
 
Species for which acquired resistance may be a problem
 
Aerobic Gram-positive micro-organisms

Enterococcus faecium $

Aerobic Gram-negative micro-organisms

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Proteus mirabilis

Proteus vulgaris
 
Inherently resistant organisms
 
Aerobic Gram-negative micro-organisms

Acinetobacter sp.

Citrobacter freundii

Enterobacter sp.

Legionella pneumophila

Morganella morganii

Providencia spp.

Pseudomonas sp.

Serratia sp.

Stenotrophomonas maltophilia

Other micro-organisms

Chlamydophila pneumoniae

Chlamydophila psittaci

Coxiella burnetti

Mycoplasma pneumoniae
 
$ Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

£All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid

1Streptococcus pneumoniae that are resistant to penicillin should not be treated with this presentation of amoxicillin/clavulanic acid (see sections 4.2 and 4.4).

2 Strains with decreased susceptibility have been reported in some countries in the EU with a frequency higher than 10%.
 

5.2 Pharmacokinetic properties
  Absorption

Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. Following oral administration, amoxicillin and clavulanic acid are approximately 70% bioavailable. The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax) in each case is approximately one hour.

The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (500 mg/125 mg tablets three times daily) was administered in the fasting state to groups of healthy volunteers are presented below.

Mean (± SD) pharmacokinetic parameters
 
Active substance(s) administered
 Dose
 Cmax
 Tmax *
 AUC (0-24h)
 T 1/2
 
(mg)
 (μg/ml)
 (h)
 ((μg.h/ml)
 (h)
 
Amoxicillin
 
AMX/CA

500/125 mg
 500
 7.19

± 2.26
 1.5

(1.0-2.5)
 53.5

± 8.87
 1.15

± 0.20