APX-AMOXICILLIN/CLAVULANIC ACID 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet strip 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:

Arrotex Pharmaceuticals Pty Ltd

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

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). 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 APX-AMOXICILLIN/CLAVULANIC ACID 875/125 tablets. 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 susceptibility 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 APX-AMOXICILLIN/CLAVULANIC ACID 875/125 tablets should not require the addition of another antibiotic due to the amoxycillin content of APX-AMOXICILLIN/CLAVULANIC ACID 875/125 tablets. Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). 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 CURAM/MURIC tablets. 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 susceptibility 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 CURAM/MURIC tablets should not require the addition of another antibiotic due to the amoxycillin content of CURAM/MURIC tablets.

Product summary:

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

Authorization status:

Registered

Authorization date:

2021-04-22

Patient Information leaflet

APX-AMOXICILLIN/CLAVULANIC ACID 500/125; APX-AMOXICILLIN/CLAVULANIC
ACID 875/125
1
APX-
AMOXICILLIN/CLAVULANIC
ACID 500/125; APX-
AMOXICILLIN/CLAVULANIC
ACID 875/125
_amoxicillin trihydrate and potassium clavulanate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about APX-
Amoxicillin/Clavulanic acid 500/125
and APX-Amoxicillin/Clavulanic
acid 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 APX-
AMOXICILLIN/
CLAVULANIC ACID
500/125 AND APX-
AMOXICILLIN/
CLAVULANIC ACID
875/125 ARE 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 _
APX-Amoxicillin/Clavulanic acid
500/125 and APX-
Amoxicillin/Clavulanic acid 875/125
work 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
APX-AMOXICILLIN/
CLAVULANIC ACID
500/125 OR APX-
AMOXICILLIN/
CLAVULANIC ACID
875/125
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amoxicillin trihydrate or
pota

Summary of Product characteristics

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
APX-AMOXICILLIN/CLAVULANIC ACID 500/125 AND APX-
AMOXICILLIN/CLAVULANIC ACID 875/125 (AMOXICILLIN
TRIHYDRATE/POTASSIUM CLAVULANATE) TABLETS
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate and Potassium clavulanate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-Amoxicillin/Clavulanic acid 500/125 and APX-Amoxicillin/Clavulanic
acid 875/125
tablet preparations are a combination products containing amoxicillin
trihydrate and potassium
clavulanate.
APX-Amoxicillin/Clavulanic acid 500/125 tablets contain amoxicillin
(as trihydrate) 500 mg
and clavulanic acid (as potassium clavulanate) 125 mg.
APX-Amoxicillin/Clavulanic acid 875/125 tablets contain amoxicillin
(as trihydrate) 875 mg
and clavulanic acid (as potassium clavulanate) 125 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
APX-Amoxicillin/Clavulanic acid 500/125 tablets: Off-white, oval,
biconvex, film-coated and
scored on both sides.
APX-Amoxicillin/Clavulanic acid 875/125 tablets: White to pale yellow,
oblong, biconvex,
film-coated and scored on both sides.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC 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 obtaini