APO-AMOXY/CLAV 500/125 amoxicillin 500 mg and clavulanic acid 125 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 575 mg; potassium clavulanate, Quantity: 148.875 mg

Available from:

Medreich Australia Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; isopropyl alcohol; microcrystalline cellulose; propylene glycol; purified talc; dichloromethane; hypromellose; ethylcellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit

Administration route:

Oral

Units in package:

60, 2, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-Amoxy/Clav 500/125 and APO-Amoxy/Clav 875/125 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 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 the amoxicillin content of these products.

Product summary:

Visual Identification: A white oval shaped film coated tablets with marking 'CA625' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-17

Patient Information leaflet

APO-AMOXY/CLAV TABLETS
1
APO-AMOXY/CLAV
500/125 & APO-
AMOXY/CLAV 875/125
_Amoxicillin trihydrate & Potassium clavulanate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take APO-
AMOXY/CLAV 500/125 or APO-
AMOXY/CLAV 875/125 tablets.
This leaflet answers some common
questions about APO-
AMOXY/CLAV 500/125 and APO-
AMOXY/CLAV 875/125 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 new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking APO-
AMOXY/CLAV 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 APO-
AMOXY/CLAV 500/125
AND APO-
AMOXY/CLAV 875/125
TABLETS USED FOR?
APO-AMOXY/CLAV tablets
contain two active ingredients. One
of these is a penicillin called
amoxycillin and the other is
clavulanic acid.
APO-AMOXY/CLAV tablets belong
to the penicillin group of antibiotics.
APO-AMOXY/CLAV tablets are
used for the short term treatment of a
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.
APO-AMOXY/CLAV tablets work
by killing the bacteria that causes
these infections. APO-
AMOXY/CLAV tablets will not
work against infections caused by
viruses such as colds or the flu.
Your doctor may prescribe APO-
AMOXY/CLAV tablets for another
use. If you want more information,
ask your doctor.
There is no evidence that APO-
AMOXY/CLAV tablets are
addictive.
BEFORE YOU TAKE APO-
AMOXY/CLAV 500/125
OR APO-AMOXY/CLAV
875/125
DO NOT TAKE APO-AMOXY/CLAV
TABLETS IF:
•
you have had an allergic reaction
to penicillin or similar types of
antibiotics (su

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-AMOXY/CLAV 500/125 AND APO-AMOXY/CLAV
875/125 (AMOXICILLIN TRIHYDRATE AND POTASSIUM
CLAVULANATE) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO
‐
AMOXY/CLAV
500/125
and
APO
‐
AMOXY/CLAV
875/125
tablets
(amoxicillin
and
clavulanic acid tablets) are combination products containing the
semisynthetic antibiotic,
amoxicillin (as the trihydrate) and the β-lactamase inhibitor,
potassium clavulanate (as the
potassium salt of clavulanic acid).
Each film coated tablet contains 500 mg amoxicillin as the trihydrate
and 125 mg clavulanic
acid as the potassium salt.
Each film coated tablet contains 875 mg amoxicillin as the trihydrate
and 125 mg clavulanic
acid as the potassium salt.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO
‐
AMOXY/CLAV 500/125 Tablets:
A white, oval shaped, film coated tablet with marking “CA625” on
one side.
APO
‐
AMOXY/CLAV 875/125 Tablets:
A white elongated capsule shaped film coated tablet.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO
‐
AMOXY/CLAV 500/125 and APO
‐
AMOXY/CLAV 875/125 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 amoxicillin
and clavulanic acid tablets.
2
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
obtainin