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 1750 mg amoxicillin/ 250 mg clavulanic acid with twice daily dosing and 2625 mg amoxicillin/375 mg clavulanic acid with three times daily dosing, when administered as recommended below. For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 1000-2800 mg amoxicillin/143-400 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

Recommended doses:

•     standard dose (for all indications): 875 mg/125 mg two times a day; 
•     higher dose (particularly for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 875 mg/125 mg three times a day.

Children < 40 kg

Children may be treated with Augmentin tablets or suspensions.
Recommended doses:

•     25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses; 
•     up to 70 mg/10 mg/kg/day given as two divided doses may be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections).

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 875 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]
12.5 – 22.5 per single dose (1 film-coated        21.9   25.0   29.2   35.0
(up to 35) tablet)


Clavulanic acid [mg/kg body
1.8 – 3.2 weight] per single dose (1 film-     3.1    3.6     4.2    5.0
(up to 5) coated tablet)
Children weighing less than 25 kg should preferably be treated with Augmentin suspension .

No clinical data are available for Augmentin 7:1 formulations regarding doses higher than 45 mg/6.4 mg per kg per day in children under 2 years

There are no clinical data for Augmentin 7:1 formulations for patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.

Elderly

No dose adjustment is considered necessary.
Renal impairment

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

In patients with creatinine clearance less than 30 ml/min, the use of Augmentin presentations with an amoxicillin to clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available.

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 SmPC of the IV formulation and continued with an oral preparation.