AUGMENTIN ES POWDER FOR ORAL SUSPENSION

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

AMOXICILLIN TRIHYDRATE EQV (AMOXICILLIN FREE ACID); POTASSIUM CLAVULANATE EQV CLAVULANIC ACID

Disponible desde:

GLAXOSMITHKLINE PTE LTD

Código ATC:

J01CR02

Dosis:

600 mg/5 ml

formulario farmacéutico:

POWDER, FOR SUSPENSION

Composición:

AMOXICILLIN TRIHYDRATE EQV (AMOXICILLIN FREE ACID) 600 mg/5 ml; POTASSIUM CLAVULANATE EQV CLAVULANIC ACID 42.9 mg/5 ml

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

Glaxo Wellcome Production

Estado de Autorización:

ACTIVE

Fecha de autorización:

2006-04-20

Información para el usuario

1 
AUGMENTIN ES
 
AMOXICILLIN TRIHYDRATE - POTASSIUM CLAVULANATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_AUGMENTIN ES_ contains 600 mg amoxicillin
(as amoxicillin trihydrate) and 42.9 mg 
clavulanic acid (as potassium clavulanate) per 5 ml, a 14:1
ratio_._ 

PHARMACEUTICAL FORM 
Strawberry cream flavour 
Off-white powder with a characteristic strawberry odour, which,
when constituted in 
water at time of dispensing, yields an off-white suspension. 
CLINICAL PARTICULARS 
INDICATIONS 
AUGMENTIN should be used in accordance with local
official antibiotic-prescribing 
guidelines and local susceptibility data. 
_AUGMENTIN ES _is indicated for the treatment of paediatric patients with acute otitis 
media due to _Streptococcus pneumoniae_ (penicillin minimum inhibitory concentration 
(MIC) less than or equal to < 2 
µg/ml), _Haemophillus  influenzae_ (including beta-
lactamase-producing strains) and _Moraxella
catarrhalis _(including beta-lactamase-
producing strains). Such patients are often characterised
by antibiotic exposure for acute 
otitis media within the preceeding 3 months, and
are either aged < 2 years or attend 
daycare. 

Susceptibility to AUGMENTIN will vary with geography and time.
 Local susceptibility 
data should be consulted where available, and
microbiological sampling and 
susceptibility testing performed where necessary. 

DOSAGE AND ADMINISTRATION 
PAEDIATRIC PATIENTS 3 MONTHS AND OLDER: 

The recommended dose
for _AUGMENTIN_ _ES_ is 90/6.4 mg/kg/day in 2 divided
doses at 
12-hourly intervals for 10
days, (see chart below). There is no experience in paediatric 
patients weighing > 40 kg, or in adults.  There are no
clinical data on 
AUGMENTIN ES in 
children under 3 months of age. 

2 
BODY WEIGHT (KG) 
VOLUME OF _AUGMENTIN_ _ES _ PROVIDING 
90/6.4

Ficha técnica

1
AUGMENTIN ES
AMOXICILLIN TRIHYDRATE - POTASSIUM CLAVULANATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Off-white powder which, when reconstituted, yields an off-white to tan
coloured,
strawberry flavoured suspension.
When reconstituted, each 5 mL contains 600 mg amoxicillin (as
amoxicillin trihydrate)
and 42.9 mg clavulanic acid (as potassium clavulanate), a 14:1
ratio_._
CLINICAL INFORMATION
INDICATIONS
_AUGMENTIN ES_ should be used in accordance with local official
antibiotic-prescribing
guidelines and local susceptibility data.
_AUGMENTIN ES _is indicated for the treatment of paediatric patients
with acute otitis
media due to _Streptococcus pneumoniae_ (penicillin minimum inhibitory
concentration
(MIC) less than or equal to < 2

g/mL), _Haemophilus influenzae_ (including beta-
lactamase producing strains) and _Moraxella catarrhalis _(including
beta-lactamase
producing strains). Such patients are often characterised by
antibiotic exposure for acute
otitis media within the preceding 3 months, and are either aged < 2
years or attend
daycare.
Susceptibility to _AUGMENTIN ES_ will vary with geography and time.
Local
susceptibility data should be consulted where available, and
microbiological sampling
and susceptibility testing performed where necessary.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Powder for oral suspension.
PAEDIATRIC PATIENTS 3 MONTHS AND OLDER:
The recommended dose for _AUGMENTIN_ _ES_ is 90/6.4 mg/kg/day in 2
divided doses at
12-hourly intervals for 10 days (see chart below). There is no
experience in paediatric
patients weighing more than 40 kg, or in adults. There are no clinical
data on
_AUGMENTIN_ _ES _in children under 3 months of age.
BODY WEIGHT (KG)
VOLUME OF _AUGMENTIN_ _ES _PROVIDING 90/6.4 MG/KG/DAY_ _
2
8
3.0 mL twice daily
12
4.5 mL twice daily
16
6.0 mL twice daily
20
7.5 mL twice daily
24
9.0 mL twice daily
28
10.5 mL twice daily
32
12.0 mL twice daily
36
13.5 mL twice daily
_ _
_AUGMENTIN ES_ does not contain the same amount of_ _clavulanate (as
the potassium salt)
as any o