CLAVAM 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,potassium clavulanate

Available from:

Pharmacor Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Authorization status:

Registered

Patient Information leaflet

1
CLAVAM VER-01 MAR 2018
CLAVAM
(Amoxicillin & Clavulanic Acid)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully before
you take Clavam tablets.
This
leaflet
answers
some
common
questions about 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 new risks are found even
when a medicine has been used for many
years.
Your
doctor
has
weighed
the
expected benefits of you taking 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
CLAVAM TABLETS USED
FOR?
Clavam
tablets
contain
two
active
ingredients. One of these is a penicillin
called
amoxycillin
and
the
other
is
clavulanic acid. Clavam tablets belong to
the penicillin group of antibiotics.
Clavam tablets are used for the short term
treatment
of
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.
Clavam tablets work by killing the bacteria
that
cause
these
infections.
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 CLAVAM TABLETS
_DO NOT TAKE 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 Clavam 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 the face or tongue.
*
you ha

Summary of Product characteristics

PRODUCT INFORMATION
CLAVAM 875MG/125MG TABLETS
VER-01 MAR 2018
Page
1
of
16
PRODUCT INFORMATION
CLAVAM 875MG/125MG TABLETS
(A
MOXICILLIN AND POTASSIUM CLAVULANATE TABLETS
)
NAME OF THE MEDICINE
Amoxicillin trihydrate and Potassium clavulanate.
CHEMICAL NAMES:
Amoxicillin trihydrate: (2
_S_
,5
_R_
,6R)-6-[(
_R_
)-2-amino-2-(4-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.
STRUCTURAL FORMULAE:
Amoxicillin trihydrate:
Potassium clavulanate:
MOLECULAR FORMULAE:
Amoxicillin trihydrate: C
16
H
19
N
3
O
5
S.3H
2
0
Potassium clavulanate: C
8
H
8
KNO
5
MOLECULAR WEIGHTS:
Amoxicillin trihydrate: 419.5
Potassium clavulanate: 237.3
CAS REGISTRY NUMBERS:
Amoxicillin trihydrate: 61336-70-7
PRODUCT INFORMATION
CLAVAM 875MG/125MG TABLETS
VER-01 MAR 2018
Page
2
of
16
Potassium clavulanate: 61177-45-5
DESCRIPTION
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). It is susceptible to
hydrolysis by β- lactamases.
Clavulanic acid is produced by the fermentation of
_Streptomyces clavuligerus_
. It is an
irreversible inhibitor of many β-lactamase enzymes except type 1
(Richmond). It is a β-
lactam compound with only weak antibacterial activity.
CLAVAM 875MG/125MG TABLETS
also contain the inactive ingredients: magnesium stearate,
sodium starch glycollate, colloidal anhydrous silica and
microcrystalline cellulose.
The
tablet
coating
contains
Insta
Moistshield
(PI
108592),
isopropyl
alcohol
and
dichloromethane.
PHARMACOLOGY
PHARMACOKINETICS
_Absorption _
_ _
Amoxicillin and potassium clavulanate tablets are stable in the
presence of gastric acid. Their
two components are rapidly absorbed if administered before or with a
meal, but if given after
meals, the serum levels of clav