AUGMENTIN DUO amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium clavulanate)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin, Quantity: 500 mg; clavulanic acid, Quantity: 125 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

amoxicillin,Clavulanic acid

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate; dimeticone 5000; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000; macrogol 4000

Administration route:

Oral

Units in package:

60 tablets, 10 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Augmentin tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology): Urinary Tract Infections (uncomplicated and complicated); Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis; Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis; Skin and Skin Structure Infections. Appropriate culture and susceptibility studies should be performed to identify the causative organisms(s) and its (their) susceptibility to Augmentin tablets. However, when there is reason to believe an infection may involve any of the B-lactamase producing 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 treatment of mixed infections caused by amoxycillin susceptible organisms and B-lactamase producing organisms susceptible to Augmentin tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Product summary:

Visual Identification: A white, oval shaped, biconvex plain film coated tablet debossed with 'AC' and a score line on one side and plain on the other side. Approximately 20 mm by 9.5 mm and about 7.5 mm thick. The total nominal weight is 1.080g.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-10-18

Patient Information leaflet

1
AUGMENTIN
® DUO &
AUGMENTIN
® DUO FORTE TABLETS
_Amoxicillin trihydrate & Potassium clavulanate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AUGMENTIN DUO
or AUGMENTIN DUO FORTE
tablets.
This leaflet answers some
common questions about
AUGMENTIN DUO and
AUGMENTIN DUO FORTE tablets.
It does not contain all of the
available information.
It does not take the place of
talking to your 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 doctor has weighed the
expected benefits of you taking
AUGMENTIN tablets against the
risks this medicine could have for
you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT ARE AUGMENTIN
DUO AND AUGMENTIN
DUO FORTE TABLETS
USED FOR?
AUGMENTIN tablets contain two
active ingredients. One of these
is a penicillin called amoxicillin
and the other is clavulanic acid.
AUGMENTIN tablets belong to the
penicillin group of antibiotics.
AUGMENTIN tablets are 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 tablets work by
killing the bacteria that cause
these infections. AUGMENTIN
tablets will not work against
infections caused by viruses such
as colds or the flu.
Your doctor may prescribe
AUGMENTIN tablets for another
use. If you want more
information, ask your doctor.
There is no evidence that
AUGMENTIN tablets are addictive.
BEFORE YOU TAKE
AUGMENTIN DUO OR
AUGMENTIN DUO
FORTE TABLETS
_ _
_DO NOT TAKE AUGMENTIN _
_TABLETS IF: _
•
you have had an allergic
reaction to penicillin or similar
types of antibiotics (such as
cephalosporins) or any of the
ingredients contained in
AUGMENTIN DUO or
AUGMENTIN DUO FORTE
tablets.
The in

Summary of Product characteristics

Augmentin-tablets-pi-feb20
1
AUSTRALIAN PRODUCT INFORMATION
AUGMENTIN
® DUO AND AUGMENTIN
® DUO FORTE (AMOXICILLIN
TRIHYDRATE AND POTASSIUM CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin Trihydrate and Potassium Clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN
DUO
and
AUGMENTIN
DUO
FORTE
tablets
(AUGMENTIN
TABLETS)
are
combination products containing the semisynthetic antibiotic,
amoxicillin (as the trihydrate)
and the
β
-lactamase inhibitor, potassium clavulanate (as the potassium salt of
clavulanic
acid).
AUGMENTIN DUO FORTE TABLETS also contain the inactive ingredients:
magnesium stearate,
sodium starch glycollate, colloidal anhydrous silica and
microcrystalline cellulose. The tablet
coating contains titanium dioxide, hypromellose 5 & 15 cps, Macrogol
4000 & Macrogol 6000.
AUGMENTIN DUO TABLETS also contain the inactive ingredients magnesium
stearate, sodium
starch glycollate, colloidal anhydrous silica and microcrystalline
cellulose. The tablet coating
contains titanium dioxide, hypromellose 5cps, hypromellose 15cps,
Macrogol 4000, Macrogol
6000 and dimethicone 500.
3
PHARMACEUTICAL FORM
AUGMENTIN DUO FORTE Tablets: A white to off-white capsule shaped film
coated tablet,
debossed with “AC” and a scoreline on one side and “AC” only
on the other side. Each film
coated tablet contains 875mg amoxicillin as the trihydrate and 125mg
clavulanic acid as the
potassium salt. Available as PVC/PVDC blister packs of 2, 10 and 60.
AUGMENTIN DUO Tablets: A white, oval shaped, biconvex film coated
tablet debossed with
“AC” and a scoreline on one side and plain on the other. Each film
coated tablet contains
500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the
potassium salt. Available
as PVC/PVDC blister packs of 2, 10 and 60.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AUGMENTIN TABLETS are indicated for short term treatment of bacterial
infections at the
following sites when caused by sensitive organisms (refer to
Microbiology):
Augmentin-tablets-pi-feb20
2
Uri