APO-AMOXYCILLIN AND CLAVULANIC ACID 875/125 amoxicillin 875 mg and clavulanic acid 125 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1004.5 mg (Equivalent: amoxicillin, Qty 875 mg); potassium clavulanate, Quantity: 148.87 mg (Equivalent: clavulanic acid, Qty 125 mg)

Available from:

Apotex Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: ethylcellulose; purified talc; triethyl citrate; polysorbate 80; crospovidone; croscarmellose sodium; magnesium stearate; hyprolose; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amoxycillin and Clavulanic Acid 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 organism(s) and determine its (their) susceptibility to Amoxycillin and Clavulanic Acid Tablets. However, when there is 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 susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infection

Product summary:

Visual Identification: WHITE TO OFF-WHITE OBLONG FILM-COATED TABLET WITH BEVELLED EDGES, SCORED AND DEBOSSED WITH 875/125 ON ONE SIDE AND DEBOSSED WITH AMC ON THE OTHER SIDE.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-11-04

Patient Information leaflet

APO-AMOXYCILLIN AND CLAVULANIC ACID 875MG/125MG
1
APO- AMOXYCILLIN AND
CLAVULANIC ACID
875MG/125MG TABLETS
_Amoxicillin trihydrate and potassium clavulanate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about amoxycillin and
clavulanic acid. 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 using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Amoxycillin and clavulanic acid is
used to treat a wide range of
infections caused by bacteria. These
infections may affect the chest
(bronchitis or pneumonia), bladder
(cystitis), sinuses (sinusitis), ears
(otitis media) or skin.
_HOW IT WORKS _
Amoxycillin is a type of penicillin
antibiotic. Clavulanic acid is used to
help the amoxycillin work better
against certain types of bacteria.
Amoxycillin and clavulanic acid
works by killing the bacteria that
cause these infections. It will not
work against infections such as colds
or the flu, which are caused by
viruses.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
These tablets are not recommended
for children weighing less than 40
kg.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amoxicillin
•
other penicillins or
cephalosporins
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- AMOXYCILLIN AND CLAVULANIC ACID 875MG/125MG
(AMOXICILLIN TRIHYDRATE AND POTASSIUM
CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amoxicillin trihydrate equivalent to amoxicillin
875 mg and potassium
clavulanate equivalent to clavulanic acid 125mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO- AMOXYCILLIN AND CLAVULANIC ACID 875 MG/125MG TABLETS:
White to off-white oblong film-coated tablets with bevelled edges,
scored and debossed, with
875/125 on one side and debossed with AMC on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin and clavulanic acid tablets are indicated for short term
treatment of bacterial infections
at
the
following
sites
when
caused
by
sensitive
organisms
(refer
to
section
5.1
PHARMACODYNAMIC PROPERTIES - MECHANISM OF ACTION, 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 Infection
Appropriate culture and susceptibility studies should be performed to
identify the causative
organism(s) and determine its (their) susceptibility to amoxicillin
and clavulanic acid tablets.
However, when there is 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 susceptibility studies. Once these results are
known, therapy should be
adjusted if appropriate.
The treatment of mixed infections caused by amoxicillin susceptible
organisms and beta-
lactamase producing organisms susceptible to amoxicillin and
clavulanic acid tablets should
not require the addition of another antibiotic due to