AMOXYCLAV AN 500/125 amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium clavulanate) 125 mg tablet blister pac

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate,potassium clavulanate

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Patient Information leaflet

________________________________________________________________________________
C:Products/Amoxyclav AN/CMI_1 31072015
Page
1 of 4
AMOXYCLAV AN
_[amoxicillin trihydrate and potassium clavulanate] _
CONSUMER MEDICINE INFORMATION
_ _
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START AMOXYCLAV AN.
What is in this leaflet
This leaflet answers some common
questions about this medicine.
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 being given this medication
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to
read it again.
What this medicine is
used for
Amoxyclav AN tablets contain two
active ingredients. One of these is
from the penicillin group of antibiotics
and is called amoxicillin (from
amoxicillin trihydrate) and the other is
clavulanic acid (from potassium
clavulanate). Amoxyclav AN tablets
are used to treat a wide range of
infections caused by bacteria. These
infections may affect the chest
(bronchitis or pneumonia), bladder
(cystitis), sinuses (sinusitis), the ears
(otitis media) or the skin.
Amoxyclav AN tablets work by
killing the bacteria that cause these
infections. Amoxyclav AN tablets will
not work against infections caused by
viruses such as colds or the flu.
Your doctor may prescribe Amoxyclav
AN tablets for another use. If you
want more information ask your
doctor.
There is no evidence that Amoxyclav
AN tablets are addictive.
Before you take it
_Do not take Amoxyclav AN 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 Amoxyclav AN
tablets. The ingredients are
listed at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
skin rash, itching, difficulty in
breathing and swelling of

Summary of Product characteristics

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Page 1 of 17
PRODUCT INFORMATION
AMOXYCLAV AN 500/125 & AMOXYCLAV AN 875/125
NAME OF THE MEDICINE
PROPRIETARY NAMES:
AMOXYCLAV AN 500/125 & AMOXYCLAV 875/125 TABLETS
NON PROPRIETARY NAME:
amoxicillin (as trihydrate) & clavulanic acid (as potassium
clavulanate) tablets
CHEMICAL NAMES:_ _
Amoxicillin trihydrate:
(2
_S_
,5
_R_
,6
_R_
)-6-[(
_R_
)-(-)-2-Amino-2-(
_p_
–hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Potassium clavulanate:
Potassium (
_Z_
)-(2
_R_
,5
_R_
)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-
carboxylate.
MOLECULAR FORMULA AND MOLECULAR WEIGHT:
Amoxicillin trihydrate – the molecular formula is C
16
H
19
N
3
O
5
S
ּ
◌3H
2
O, and
the molecular weight is 419.46.
Potassium clavulanate – the molecular formula is C
8
H
8
KNO
5
, and
the molecular weight is 237.25.
STRUCTURES:
_ _
The chemical structure of amoxicillin trihydrate is:
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The chemical structure of potassium clavulanate is:
CAS NUMBERS:
Amoxicillin trihydrate - 61336-70-7, and
Potassium clavulanate - 61177-45-5
_ _
DESCRIPTION
Amoxicillin is a semi-synthetic antibiotic.
Amoxicillin trihydrate is a white to off white crystalline powder and
is slightly soluble in
water.
Clavulanic acid is an irreversible inhibitor of many beta-lactamase
enzymes except type 1
(Richmond). It is a beta-lactam compound with only weak antibacterial
activity in its own
right.
Potassium clavulanate is a white to off white hygroscopic crystalline
powder and is freely
soluble in water.
Amoxyclav AN 500/125 tablet is an immediate release tablet form and
each tablet contains
amoxicillin (as trihydrate) equivalent to 500 mg amoxicillin and
potassium clavulanate
equivalent to 125 mg clavulanic acid.
Amoxyclav AN 875/125 tablet is an immediate release tablet form and
each tablet contains
amoxicillin (as trihydrate) equivalent to 875 mg amoxicillin and
potassium clavulanate
equivalent to 125 mg