Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet
White to off-white, oval film-coated tablets debossed with 'AC' and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Clinical particulars
Therapeutic indications
Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
• Acute bacterial sinusitis (adequately diagnosed)
• Acute otitis media
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Augmentin that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).
For adults and children ≥ 40 kg, this formulation of Augmentin provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1).
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy).
Adults and children ≥ 40 kg
One 500 mg/125 mg dose taken three times a day.
Children < 40 kg
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.
Children may be treated with Augmentin tablets, suspensions or paediatric sachets.
As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets.
The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet.

Children aged 6 years and below or weighing less than 25 kg should preferably be treated with Augmentin suspension or paediatric sachets.

No clinical data are available on doses of Augmentin 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.

Elderly

No dose adjustment is considered necessary.

Renal impairment

Dose adjustments are based on the maximum recommended level of amoxicillin.

No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

Adults and children ≥ 40 kg

Children < 40 kg