AUGMENTIN DUO 400 powder for oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clavulanic acid, Quantity: 11.4 mg/mL; amoxicillin, Quantity: 80 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: silicon dioxide; succinic acid; colloidal anhydrous silica; aspartame; xanthan gum; hypromellose; Flavour

Administration route:

Oral

Units in package:

125ml, 60ml, 50mL, 1 x single dose (starter pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Augmentin Duo 400 oral suspension is indicated in the short term treatment of the following bacterial infections when caused by sensitive organisms (see Microbiology). Skin and skin structure infections: Urinary tract infections (complicated and uncomplicated): Upper respiratory tract infections including sinusitis, otitis media: Lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Augmentin. However, when there is good reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to Augmentin Duo 400, should not require the addition of another antibiotic due to the amoxycillin content of Augmentin Duo 400.

Product summary:

Visual Identification: Off- white free flowing powder with a characteristic. Off white suspension is formed which slowly deposits a slight white sediment on standing .; Container Type: Bottle; Container Material: Glass Type III Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1999-02-12

Patient Information leaflet

1
AUGMENTIN
® DUO 400 SUSPENSION
_Amoxicillin trihydrate & Potassium clavulanate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you give AUGMENTIN
DUO 400 SUSPENSION.
This leaflet answers some
common questions about
AUGMENTIN DUO 400
SUSPENSION. It does not
contain all of the available
information.
It does not take the place of
talking to your child’s doctor or
pharmacist.
All medicines have risks and
benefits. Sometimes new risks
are found even when a medicine
has been used for many years.
Your child’s doctor has weighed
the expected benefits of your child
taking AUGMENTIN DUO 400
SUSPENSION against the risks
this medicine could have for your
child.
If you have any concerns about
your child taking this medicine,
ask your child’s doctor or
pharmacist.
Keep this leaflet until your child
has finished the course of
AUGMENTIN DUO 400
SUSPENSION.
You may need to read it again.
WHAT IS AUGMENTIN
DUO 400
SUSPENSION USED
FOR?
AUGMENTIN DUO 400
SUSPENSION contains two
active ingredients. One of these
is a penicillin called amoxicillin
and the other is clavulanate.
AUGMENTIN DUO 400
SUSPENSION belongs to the
penicillin group of antibiotics.
AUGMENTIN DUO 400
SUSPENSION is used for the
short term treatment of a wide
range of infections caused by
bacteria. These infections may
affect the chest (e.g. bronchitis or
pneumonia), bladder (e.g.
cystitis), sinuses (e.g. sinusitis),
the ears (e.g. otitis media) or the
skin.
AUGMENTIN DUO 400
SUSPENSION works by killing the
bacteria that cause these
infections.
AUGMENTIN DUO 400
SUSPENSION is used for the
treatment of the infections listed.
However, the doctor may
prescribe these medicines for
another use. If you want more
information ask the doctor.
There is no evidence that
AUGMENTIN DUO 400
SUSPENSION is addictive.
BEFORE YOU GIVE
AUGMENTIN DUO 400
SUSPENSION
_ _
_AUGMENTIN DUO 400 _
_SUSPENSION MUST NOT BE _
_GIVEN IF: _
•
your child is allergic to
penicillin or similar types of
antibiotics (such as
cephalosporins) or a

Summary of Product characteristics

Augmentin-Duo-400-pi
1
AUSTRALIAN PRODUCT INFORMATION
AUGMENTIN
® DUO 400 (AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE)
POWDER FOR SUSPENSION
1
NAME OF THE MEDICINE
Amoxicillin Trihydrate and Potassium Clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN
®
DUO 400 is a combination product containing the semisynthetic
antibiotic,
amoxicillin (as the trihydrate) and the
β
-lactamase inhibitor, potassium clavulanate (as
the potassium salt of clavulanic acid).
AUGMENTIN DUO 400 Oral Suspension: Each 5mL of reconstituted off-white
mixed fruit
flavoured suspension contains 400 mg amoxicillin and 57 mg clavulanic
acid as the
potassium salt.
NOTE: AUGMENTIN DUO 400 oral suspension contains aspartame 12.5mg per
5mL. Each
125 mg of potassium clavulanate is equivalent to 0.63 mmol of
potassium.
Excipients with known effect: aspartame.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
An off-white dry powder for reconstitution in water to form an
off-white mixed-fruit
flavoured suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AUGMENTIN DUO 400 oral suspension is indicated in the short term
treatment of the
following bacterial infections when caused by sensitive organisms
­
Skin and Skin Structure Infections
­
Urinary Tract Infections (complicated and uncomplicated)
­
Upper Respiratory Tract Infections including sinusitis and otitis
media
­
Lower
Respiratory
Tract
Infections
including
acute
exacerbations
of
chronic
bronchitis and community acquired pneumonia
Appropriate
culture
and
susceptibility
studies
should be
performed to
identify the
causative organism(s) and determine its (their) susceptibility to
AUGMENTIN. However,
when there is reason to believe an infection may involve any of the
β
-lactamase producing
Augmentin-Duo-400-pi
2
organisms listed above, therapy may be instituted prior to obtaining
the results from
bacteriological and susceptibility studies. Once these results are
known, therapy should
be adjusted if appropriate.
The treatme