AMOXICILLIN/CLAVULANIC ACID VIATRIS 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1005 mg (Equivalent: amoxicillin, Qty 875 mg); potassium clavulanate, Quantity: 149 mg (Equivalent: clavulanic acid, Qty 125 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: Skin and skin structure infections. Urinary tract infections (complicated and uncomplicated). Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, 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 cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.

Product summary:

Visual Identification: White to pale yellow, oblong, biconvex, film-coated tablets, scored on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-10-16

Patient Information leaflet

ALPHACLAV DUO 500/125;
ALPHACLAV DUO FORTE
875/125
_amoxicillin and potassium clavulanate tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alphaclav Duo
500/125 and Alphaclav Duo Forte
875/125.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will 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 THIS MEDICINE IS
USED FOR
This medicine contains two active
ingredients. One of these ingredients
is a type of penicillin called
amoxicillin and the other is
potassium clavulanate.
It is used to treat a wide range of
infections in the body caused by
bacteria. These infections may affect
the chest (bronchitis or pneumonia),
bladder (cystitis), sinuses (sinusitis),
the ears (otitis media) or the skin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS_
Alphaclav Duo 500/125 and
Alphaclav Duo Forte 875/125 works
by killing the bacteria that cause
these infections. It will not work
against infections caused by viruses
such as colds or the flu.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amoxicillin trihydrate or
potassium clavulanate, the active
ingredients, or similar types of
antibiotics (e.g. penicillins,
cephalosporins, carbapenems or
monobactams) or any of the
inactive ingredients mentioned at
the end of this leaflet, under
Product Description.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or d

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ALPHACLAV DUO 500/125 & ALPHACLAV
DUO FORTE 875/125
_Amoxicillin/Clavulanic acid _
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALPHACLAV
DUO
500/125
and
ALPHACLAV
DUO
FORTE
875/125
tablet
preparations
are
combination products containing amoxicillin trihydrate and potassium
clavulanate as the active ingredients.
Each tablet contains the following active ingredients:
Amoxicillin
(as trihydrate)
Clavulanic acid
(as potassium clavulanate)
ALPHACLAV DUO 500/125 Tablets
500 mg
125 mg
ALPHACLAV
DUO
FORTE
875/125 Tablets
875 mg
125 mg
Excipients with known effect: sulfites and potassium. For the full
list of excipients, see
SECTION 6.1 LIST OF
EXCIPIENTS.
_ _
3
PHARMACEUTICAL FORM
ALPHACLAV DUO 500/125 tablets are off-white, oval, biconvex,
film-coated and scored on both sides.
ALPHACLAV DUO FORTE 875/125 tablets are white to pale yellow, oblong,
biconvex, film-coated and
scored on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of bacterial infections at the following sites
when caused by amoxicillin/clavulanic
acid sensitive, beta-lactamase producing organisms:
•
Skin and skin structure infections.
•
Urinary tract infections (complicated and uncomplicated).
•
Upper respiratory tract infections, such as sinusitis, otitis media
and recurrent tonsillitis.
•
Lower
respiratory
tract
infections,
including
community
acquired
pneumonia
and
acute
exacerbations of chronic bronchitis.
Appropriate culture and susceptibility studies should be performed to
identify the causative organism(s)
and determine its (their) susceptibility to amoxicillin/clavulanic
acid tablet preparations. However, when
there is reason to believe an infection may involve any of the
beta-lactamase producing organisms listed
in the microbiological section, therapy may be instituted prior to
obtaining the results from bacteriological
and susceptible studies. Once these results are known, therapy should
be adjusted if