PHARMACOR CLAVAM 875mg/125mg amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1012.617 mg (Equivalent: amoxicillin, Qty 875 mg); potassium clavulanate, Quantity: 149.774 mg (Equivalent: clavulanic acid, Qty 125 mg)

Available from:

Pharmacor Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: isopropyl alcohol; magnesium stearate; dichloromethane; colloidal anhydrous silica; sodium starch glycollate type A; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose

Administration route:

Oral

Units in package:

20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PHARMACOR CLAVAM 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 Infection.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to PHARMACOR CLAVAM 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to PHARMACOR CLAVAM Tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Product summary:

Visual Identification: White to off white capsule shaped, biconvex, film coated tablets debossed with AM and CL separated by break line on one side and 1000 on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-11-14

Patient Information leaflet

PHARMACOR CLAVAM
Ver: 03
1
PHARMACOR CLAVAM
(Amoxicillin & Clavulanic Acid)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take PHARMACOR
CLAVAM tablets.
This
leaflet
answers
some
common
questions
about
PHARMACOR
CLAVAM
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 ne risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits
of
you
taking
PHARMACOR
CLAVAM
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
PHARMACOR
CLAVAM TABLETS USED
FOR?
PHARMACOR
CLAVAM
tablets
contain
two
active
ingredients. One of these is a
penicillin called amoxycillin and
the
other
is
clavulanic
acid.
PHARMACOR
CLAVAM
tablets belong to the penicillin
group of antibiotics.
PHARMACOR
CLAVAM
tablets
are
used
for
the
short
term treatment of 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.
PHARMACOR
CLAVAM
tablets
work
by
killing
the
bacteria
that
cause
these
infections.
PHARMACOR
CLAVAM tablets will not work
against
infections
caused
by
viruses such as colds or the flu.
Your
doctor
may
have
prescribed it for another reason.
If
you
want
more
information
ask your doctor.
This medicine is available only
with a doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE
PHARMACOR
CLAVAM TABLETS
_DO _
_NOT _
_TAKE _
_PHARMACOR _
_CLAVAM _
_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
PHARMACOR
CLAVAM
tablets.
_The ingredients are _
_listed _
_

Summary of Product characteristics

PHARMACOR CLAVAM
Ver-04
1
AUSTRALIAN PRODUCT INFORMATION - PHARMACOR CLAVAM
875MG/125MG TABLETS (AMOXICILLIN AND POTASSIUM CLAVULANATE TABLETS)
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate and Potassium clavulanate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR CLAVAM 875MG/125MG TABLETS
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).
For full list of excipients, see
SECTION 6.1- LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
PHARMACOR CLAVAM 875 MG/125 MG TABLETS:
White to off white capsule shaped,
biconvex, film coated tablets debossed with
AM
and
CL
separated by breakline on one side and
1000 on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACOR CLAVAM 875 mg/125 mg tablets are indicated for short term
treatment of
bacterial infections at the following sites when caused by sensitive
organisms (see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES, 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 potassium clavulanate
PHARMACOR CLAVAM
Ver-04
2
tablets. However, when there is reason to believe an infection may
involve any of the β-
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 β-lactamase
producing organisms susceptible to amoxicillin and potassium
clavulanate ta