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AUGMENTIN
®
SYRUP
_Amoxycillin and Clavulanic Acid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you give AUGMENTIN
SYRUP.
This leaflet answers some
common questions about
AUGMENTIN SYRUP. It does not
contain all of the available
information.
It does not take the place of
talking to your
child’s 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
child’s doctor has weighed
the expected benefits of your child
taking AUGMENTIN SYRUP
against the risks this medicine
could have for your child.
AUGMENTIN must be given to
your child as instructed. If you
have any concerns about giving
this medicine to your child, ask
your
child’s doctor or pharmacist.
Keep this leaflet until your child
has finished the course of
AUGMENTIN SYRUP.
You may need to read it again.
WHAT IS AUGMENTIN
SYRUP USED FOR?
AUGMENTIN SYRUP contains
two active ingredients. One of
these is a penicillin called
amoxycillin and the other is
clavulanate. AUGMENTIN
SYRUP belongs to the penicillin
group of antibiotics.
AUGMENTIN SYRUP is used to
treat 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.
AUGMENTIN SYRUP works by
killing the bacteria that cause
these infections.
AUGMENTIN SYRUP is used for
the treatment of the infections
listed. However the doctor may
prescribe this medicine for
another use. If you want more
information ask the doctor.
Your doctor may have prescribed
AUGMENTIN SYRUP for another
reason.
There
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製品の特徴
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AUGMENTIN™ PRODUCT INFORMATION
(AMOXYCILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE)
NAME OF THE MEDICINE
AUGMENTIN is a combination product containing the semisynthetic antibiotic amoxycillin and the
-lactamase inhibitor, potassium clavulanate (the potassium salt of clavulanic acid). Chemically,
amoxycillin is D-(-)-
-amino-p-hydroxybenzyl-penicillin trihydrate. It is susceptible to hydrolysis
by
-lactamases.
Clavulanic acid is produced by the fermentation of _Streptomyces clavuligerus_. It is an irreversible
inhibitor of many
-lactamase enzymes except type 1 (Richmond). It is a
-lactam compound with
only weak antibacterial activity. Chemically potassium clavulanate is potassium Z-(2R,5R)-3-(B-
hydroxyethylidene) clavam-2-carboxylate.
DESCRIPTION
AUGMENTIN SYRUP also contains the inactive ingredients xanthum gum, aspartame, silicon
dioxide, silica colloidal anhydrous, succinic acid,
hypromellose and mixed fruit flavour.
PHARMACOLOGY
AUGMENTIN is stable in the presence of gastric acid. Its two components are rapidly absorbed if
administered before or with a meal, but if given after meals, the serum levels of clavulanic acid are
significantly reduced. In fasting subjects mean peak serum levels after 1 Augmentin tablet were
2.98 mg/L (range 1.2 to 5.1 ) for clavulanic acid and 3.89 mg/L (range 2.4 to 6.0 ) for amoxycillin.
These levels occurred at 30 to 120 minutes and 60 to 240 minutes respectively after dosing.
Following 1 Augmentin Forte tablet peak serum levels in fasting subjects were 3.28 to 4.72 mg/L
for clavulanic acid, and 10.28 to 12.06 mg/L for amoxycillin, and were achi
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