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

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

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

Beschikbaar vanaf:

Pharmacor Pty Ltd

INN (Algemene Internationale Benaming):

amoxicillin trihydrate,potassium clavulanate

farmaceutische vorm:

Tablet, film coated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

20 tablet

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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 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 CLAVAM Tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Product samenvatting:

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

Autorisatie-status:

Registered

Autorisatie datum:

2013-11-14

Bijsluiter

CLAVAM
Ver: 04
1
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 ne 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 (e.g. bronchitis
or
pneumonia),
bladder
(e.g.
cystitis), sinuses (e.g. sinusitis),
the ears (e.g. 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, _
_itc

Productkenmerken

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