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 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 should be treated with the adult formulations of Augmentin.

Children < 40 kg
Lower dose: 20 mg/5 mg/kg/day to 40 mg/10 mg/kg/day given in three divided doses.
Higher dose: 40 mg/10 mg/kg/day to: 60 mg/15 mg/kg/day given in three divided doses.


40 mg/10 60 mg/15                                   40 mg/10 60 mg/15 20 mg/5 m          mg/kg/    mg/kg/day                  20 mg/5 m      mg/kg/    mg/kg/day g/kg/ day.          day.    . Dose in                   g/kg/ day.      day.    . Dose in Body                                                    Body
Dose in ml        Dose in ml ml to be                   Dose in ml    Dose in ml ml to be weight                                                  weight to be given         to be      given                    to be given     to be      given (kg)                                                    (kg) every 8           given     every 8                     every 8       given     every 8 hours.          every 8     hours.                      hours.      every 8     hours.
hours.                                              hours.
2.0             0.4           0.6           NR          21.0        2.8         5.6            8.4
3.0             0.4           0.8           NR          22.0        3.0         6.0            8.8 
      4.0           0.6           1.2          NR           23.0         3.2             6.2      9.2
5.0           0.8           1.4          NR           24.0         3.2             6.4      9.6 6.0           0.8           1.6          NR           25.0         3.4             6.8      10 7.0           1.0           2.0          NR           26.0         3.6             7.0     10.4 8.0           1.2           2.2          NR           27.0         3.6             7.2     10.8 9.0           1.2           2.4          NR           28.0         3.8             7.6     11.2 10.0          1.4           2.8          NR           29.0         4.0             7.8     11.6 11.0          1.6           3.0          NR           30.0         4.0             8.0      12 12.0          1.6           3.2          4.8          31.0         4.2             8.4     12.4 13.0          1.8           3.6          5.2          32.0         4.4             8.6     12.8 14.0          2.0           3.8          5.6          33.0         4.4             8.8     13.2 15.0          2.0           4.0           6           34.0         4.6             9.2     13.6 16.0          2.2           4.4          6.4          35.0         4.8             9.4      14 17.0          2.4           4.6          6.8          36.0         4.8             9.6     14.4 18.0          2.4           4.8          7.2          37.0         5.0            10.0     14.8 19.0          2.6           5.2          7.6          38.0         5.2            10.2     15.2 20.0          2.8           5.4           8           39.0         5.2            10.4     15.6
NR – Not recommended.
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 new-borns) 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.


Alternative oral formulations of Augmentin should be considered to deliver practical dose recommendations.

Children may be treated with Augmentin tablets or suspensions. Children aged 6 years and below should preferably be treated with Augmentin suspension.

The dose (ml) to be given to the patient three times daily can also be calculated using the following formula below:


Recommended amoxicillin* dose (mg/kg/day) x weight (kg)
Dose (ml) given
=      Reconstituted amoxicillin* in suspension (mg/ml) x 3 (daily three times daily doses)
*
Only consideration of the amoxicillin component is required for this calculation.

For example, a 6 kg child treated at 20 mg/5 mg/kg/day:

20 (mg/kg/day) x 6 (kg)
Dose (ml) given
=      50 (mg/ml) x 3 (daily three times daily doses)


Dose (ml) given             120 (mg)
= three times daily          150 (mg/ml)


Dose (ml) given
=   0.8 ml three times daily
Elderly

No dose adjustment is considered necessary. Elderly patients should preferably be treated with adult formulations of Augmentin.

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

Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose (see section 6.6).

For instructions on reconstitution of the medicinal product before administration, see section 6.6.