Clavulin Syrup

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Amoxycillin trihydrate; Potassium clavulanate

Листовка

CLAVULIN(R) SYRUP
1
CLAVULIN(R) SYRUP
_Amoxycillin and Clavulanic Acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you give CLAVULIN
SYRUP.
This leaflet answers some common
questions about CLAVULIN
SYRUP.  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 your child taking
CLAVULIN SYRUP against the
risks this medicine could have for
your child.
CLAVULIN must be given to your
child as instructed.  If you have any
concerns about giving this medicine
to your child, ask your doctor or
pharmacist.
Keep this leaflet until your child has
finished the course of CLAVULIN
SYRUP.
You may need to read it again.
WHAT IS CLAVULIN
SYRUP USED FOR?
CLAVULIN SYRUP contains two
active ingredients.  One of these is a
penicillin called amoxycillin and the
other is clavulanate.  CLAVULIN
SYRUP belongs to the penicillin
group of antibiotics.
CLAVULIN SYRUP is 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.
CLAVULIN SYRUP works by
killing the bacteria that cause these
infections.
CLAVULIN 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
CLAVULIN SYRUP for another
reason.
There is no evidence that
CLAVULIN SYRUP is addictive.
BEFORE YOU GIVE
CLAVULIN SYRUP
_CLAVULIN SYRUP MUST NOT_
_BE GIVEN IF:_
*
your child is al

Данни за продукта

Clavulin
®
 125 Syrup 

PRODUCT INFORMATION 

DESCRIPTION 

CLAVULIN is a combination product containing the semisynthetic
antibiotic amoxycillin and the 
β-lactamase inhibitor, potassium clavulanate (the potassium salt of
clavulanic acid). Chemically, 
amoxycillin is D-(-)-α-amino-p-hydroxybenzyl-penicillin trihydrate.
 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.  Chemically
potassium clavulanate is potassium 
Z-(3R,5R)-2-(B-hydroxyethylidene) clavam-3-carboxylate.  

CLAVULIN also contains the inactive ingredients xanthum gum,
aspartame, silicon dioxide, silica 
colloidal anhydrous, succinic acid, hypromellose and mixed fruit
flavour.  

PHARMACOLOGY 

CLAVULIN 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.   

Following oral administration of CLAVULIN 125 syrup at a dose of
8.3 mg/Kg (amoxycillin 
6.6mg/Kg + clavulanic acid 1.7mg/Kg) to children with otitis media
the means of peak 
concentrations were 2.76 mg/L for amoxycillin and 0.78 mg/L for
clavulanic acid.  In children 
given amoxycillin syrup 16.6 mg/kg (amoxycillin 13.3 mg/kg +
clavulanic acid 3.3 mg/kg) the 
means of peak values were 4.94 mg/L for amoxycillin and 1.53 mg/L
for clavulanic acid.  Peak 
concentrations were reached at approximately 60 minutes (range 40 to
120 minutes).  

The half life of the amoxycillin part of CLAVULIN is approximately
1.2 hours and that of clavulanic 
acid approximately 1.0 hour. Following administration of CLAVULIN,
both amoxycillin and 
clavulanic acid have been shown to diffuse
in significant concentrations