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 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 should be treated with the adult formulations of Augmentin.

Children < 40 kg

•   Lower dose: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses; •   Higher dose: 45 mg/6.4 mg/kg/day 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).


25 mg/3.6 45 mg/6.4         70                                                        70
25 mg/3.6 m     45 mg/6.4 mg/kg/ day. mg/kg/ day. mg/10   mg/                                               mg/10 mg/ g/kg/ day.    mg/kg/ day.
Body                                 kg/day.              Body                                 kg/day.
weight     Dose in ml Dose in ml Dose in ml               weight
Dose in ml     Dose in ml
Dose in ml
(kg)       to be given to be given to be given            (kg) to be given    to be given to be given every 12    every 12                                   every 12       every 12 every 12                                                  every 12 hours.      hours.                                      hours.        hours.
hours.                                                    hours.

4.0              0.6          1.2           NR            22.0         3.4            6.2            9.6
5.0              0.8          1.4           NR            23.0         3.6            6.6           10.2 6.0              1.0          1.8           NR            24.0         3.8            6.8           10.6 7.0              1.2          2.0           NR            25.0         4.0            7.0           11.0 8.0              1.4          2.4           NR            26.0         4.2            7.4           11.4 9.0              1.4          2.6           NR            27.0         4.2            7.6           11.8 10.0        1.6           2.8           NR          28.0       4.4           8.0          12.4 11.0        1.8           3.2           NR          29.0       4.6           8.2          12.8 12.0        2.0           3.4           5.4         30.0       4.8           8.4          13.2 13.0        2.0           3.8           5.8         31.0       4.8           8.8          13.6 14.0        2.2           4.0           6.2         32.0       5.0           9.0          14.0 15.0        2.4           4.2           6.6         33.0       5.2           9.4          14.4 16.0        2.6           4.6           7.0         34.0       5.4           9.6          15.0 17.0        2.8           4.8           7.4         35.0       5.6           9.8          15.4 18.0        2.8           5.2           8.0         36.0       5.6          10.2          15.8 19.0        3.0           5.4           8.4         37.0       5.8          10.4          16.2 20.0        3.2           5.6           8.8         38.0       6.0          10.8          16.6
21.0        3.4           6.0           9.2         39.0       6.2          11.0          17.2
NR - Not recommended. 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.

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 two times daily can also be calculated using the following formula below:


Recommended amoxicillin* dose (mg/kg/day) x weight (kg)
Dose (ml) given two
= times daily
Reconstituted amoxicillin* in suspension (mg/ml) x 2 (divided doses)

*
Only consideration of the amoxicillin component is required for this calculation.

For example, a 14 kg child treated at 25 mg/3.6 mg/kg/day:


25 (mg/kg/day) x 14 (kg)
Dose (ml) given
= two times daily
80 (mg/ml) x 2 (divided doses)

350 (mg)
Dose (ml) given
= two times daily
160 (mg/ml)

Dose (ml) given
=     2.2 ml two times daily


      Elderly

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

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.
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 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.