QUALITATIVE AND QUANTITATIVE COMPOSITION

Co-amoxiclav 625 mg Tablets: Each tablet contains co-amoxiclav 500/125.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.

PHARMACEUTICAL FORM

Film-coated tablet

White to off-white, oval film-coated tablets and a score line one side and plain on the other side.  

Therapeutic indications

Co-amoxiclav 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

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 Co-amoxiclav that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents

• 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 Co-amoxiclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary.

For adults and children 40 kg, this formulation of Co-amoxiclav 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 Co-amoxiclav 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 Co-amoxiclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.

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.

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 Co-amoxiclav tablets, suspensions or paediatric sachets. Children aged 6 years and below should preferably be treated with Co-amoxiclav suspension or paediatric sachets.

No clinical data are available on doses of Co-amoxiclav 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

CrCl: 10-30 ml/min      500 mg/125 mg twice daily

CrCl < 10 ml/min   500 mg/125 mg once daily

Haemodialysis       500 mg/125 mg every 24 hours, plus 500 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)

Children < 40 kg

CrCl: 10-30 ml/min      15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily).

CrCl < 10 ml/min   15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg).

Haemodialysis 15 mg/3.75 mg/kg per day once daily.

Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating drug levels, 15 mg/3.75 mg per kg should be administered after haemodialysis.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).

Method of administration

Co-amoxiclav is for oral use.

Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.

Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.