Posology : מינונים

4.2    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 or suspensions.
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 mg/125 mg tablet.

Single dose recommended
Body weight [kg]               40      35      30     25     [mg/kg body weight] (see above)
Amoxicillin [mg/kg body weight] per single dose (1 film-coated      12.5    14.3    16.7   20.0             6.67 - 20 tablet)
Clavulanic acid [mg/kg body weight] per single dose (1 film-     3.1    3.6     4.2     5.0             1.67 - 5 coated tablet)

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

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.
For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination.

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

Augmentin is for oral use.

Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance.
Therapy can be started parenterally according to the SPC of the IV formulation and continued with an oral preparation.