ALKEM-AMOXICLAV 875mg/125mg amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets blister 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: magnesium stearate; microcrystalline cellulose; isopropyl alcohol; dichloromethane; sodium starch glycollate type A; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ALKEM-AMOXICLAV 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 ALKEM-AMOXICLAV 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 ALKEM-AMOXICLAV 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: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-11-14

Patient Information leaflet

ALKEM AMOXICLAV
Ver: 03
1
ALKEM AMOXICLAV
(Amoxicillin & Clavulanic Acid)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before
you
take
Alkem
Amoxiclav tablets.
This
leaflet
answers
some
common questions about Alkem
Amoxiclav 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
Alkem
Amoxiclav
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 ALKEM
AMOXICLAV TABLETS USED
FOR?
Alkem
Amoxiclav
tablets
contain two active ingredients.
One
of
these
is
a
penicillin
called amoxycillin and the other
is
clavulanic
acid.
Alkem
Amoxiclav tablets belong to the
penicillin group of antibiotics.
Alkem
Amoxiclav
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.
Alkem Amoxiclav tablets work
by killing the bacteria that cause
these
infections.
Alkem
Amoxiclav 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 ALKEM
AMOXICLAV TABLETS
_DO NOT TAKE ALKEM AMOXICLAV _
_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
Alkem
Amoxiclav
tablets.
_The _
_ingredients are listed at the_
_end of this leaflet.

Summary of Product characteristics

ALKEM-AMOXICLAV
Ver-04
1
AUSTRALIAN PRODUCT INFORMATION - ALKEM-AMOXICLAV
875MG/125MG TABLETS (AMOXICILLIN AND POTASSIUM CLAVULANATE TABLETS)
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate and Potassium clavulanate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALKEM-AMOXICLAV
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
ALKEM-AMOXICLAV 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
ALKEM-AMOXICLAV 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
ALKEM-AMOXICLAV
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 tablets