AUGMENTIN FOR ORAL SUSPENSION 457 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AMOXYCILLIN TRIHYDRATE 459.17mg/5ml EQV AMOXYCILLIN; POTASSIUM CLAVULANATE 67.9mg/5ml EQV CLAVULANIC ACID

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J01CR02

Dosage:

400 mg/5 ml

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

AMOXYCILLIN TRIHYDRATE 459.17mg/5ml EQV AMOXYCILLIN 400 mg/5 ml; POTASSIUM CLAVULANATE 67.9mg/5ml EQV CLAVULANIC ACID 57 mg/5 ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SmithKline Beecham Limited trading as SmithKline Beecham Pharmaceuticals

Authorization status:

ACTIVE

Authorization date:

1998-06-19

Patient Information leaflet

1 
AUGMENTIN
TM

SUSPENSION 228 MG/5 ML AND 457 MG/5 ML – 
MIXED FRUIT FLAVOUR 
AMOXICILLIN TRIHYDRATE – POTASSIUM CLAVULANATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_AUGMENTIN_ suspension 228 mg/5 ml contains 200 mg amoxicillin
(as amoxicillin 
trihydrate) and 28.5 mg clavulanic acid
(as potassium clavulanate) per 5 ml. 
_AUGMENTIN_ suspension 457 mg/5 ml contains 400 mg amoxicillin
(as amoxicillin 
trihydrate) and 57 mg clavulanic acid
(as potassium clavulanate) per 5 ml. 
PHARMACEUTICAL FORM 
Dry powder for reconstitution in water, at time of dispensing,
to form an oral sugar free 
suspension.

CLINICAL PARTICULARS 
INDICATIONS 
AUGMENTIN should be used in
accordance with local official antibiotic-prescribing 
guidelines and local susceptibility data. 
_AUGMENTIN_ suspension (228 mg/5 ml and 457mg/5 ml),
for twice daily oral dosing, is 
indicated for short term treatment of bacterial infections at
the following sites when 
amoxicillin resistant beta-lactamase producing strains are
suspected as the cause.  In 
other situations, amoxicillin alone should be considered. 
_Upper respiratory tract infections (including ENT)_ e.g.
recurrent tonsillitis, sinusitis, 
otitis media. 
_Lower respiratory tract infections _e.g. acute exacerbations of chronic bronchitis,
lobar 
and bronchopneumonia. 
_Urinary tract infections_ e.g. cystitis, urethritis,
pyelonephritis 
_Skin and soft _t_issue infections_ e.g. cellulitis, animal
bites. 
Susceptibility to AUGMENTIN will vary with geography and time
(see Pharmacological 
Properties,
Pharmacodynamics for further information). Local susceptibility data should 
be consulted where available, and microbiological sampling and
susceptibility testing 
performed where necessary. 

2 
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with 
_AUGMENTIN_ suscep

Summary of Product characteristics

AUGMENTIN
SUSPENSION 228 MG/5 ML AND 457 MG/5 ML –
MIXED FRUIT FLAVOUR
AMOXICILLIN TRIHYDRATE – POTASSIUM CLAVULANATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_AUGMENTIN_
suspension 228 mg/5 ml contains 200 mg amoxicillin (as amoxicillin
trihydrate) and 28.5 mg clavulanic acid (as potassium clavulanate) per
5 ml.
_AUGMENTIN_
suspension 457 mg/5 ml contains 400 mg amoxicillin (as amoxicillin
trihydrate) and 57 mg clavulanic acid (as potassium clavulanate) per 5
ml.
PHARMACEUTICAL FORM
Dry powder for reconstitution in water, at time of dispensing, to form
an oral sugar free
suspension.
CLINICAL PARTICULARS
INDICATIONS
_AUGMENTIN_
should be used in accordance with local official
antibiotic-prescribing
guidelines and local susceptibility data.
_AUGMENTIN_
suspension (228 mg/5 ml and 457mg/5 ml), for twice daily oral dosing,
is
indicated for short term treatment of bacterial infections at the
following sites when
amoxicillin resistant beta-lactamase producing strains are suspected
as the cause. In
other situations, amoxicillin alone should be considered.
_Upper respiratory tract infections (including ENT)_
e.g. recurrent tonsillitis, sinusitis,
otitis media.
_Lower respiratory tract infections _
e.g. acute exacerbations of chronic bronchitis, lobar
and bronchopneumonia.
_Urinary tract infections_
e.g. cystitis, urethritis, pyelonephritis
_Skin and soft tissue infections_
e.g. cellulitis, animal bites.
Susceptibility to
_AUGMENTIN_
will vary with geography and time (see
_Pharmacological _
_Properties, Pharmacodynamics_
for further information). Local susceptibility data should
be consulted where available, and microbiological sampling and
susceptibility testing
performed where necessary.
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with
_AUGMENTIN_
susceptible beta-lactamase-producing organisms may be treated with
_AUGMENTIN_
suspension 228 mg/5ml and 457 mg/5 ml. These infections should not
require the addition of another antibiotic resistant to
beta-lactamases.
DOSAGE AND ADMINISTRA