Augmentin Syrup 75mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium clavulanate, Quantity: 7.4 mg/mL (Equivalent: clavulanic acid, Qty 6.25 mg/mL); amoxicillin trihydrate, Quantity: 28.7 mg/mL (Equivalent: amoxicillin, Qty 25 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: silicon dioxide; hypromellose; aspartame; succinic acid; xanthan gum; colloidal anhydrous silica; Flavour

Administration route:

Oral

Units in package:

powder for 75mL Syrup, powder for 5mL, powder for 100mL Syrup(E), powder for 60mL Syrup(E), powder for 10mL(E)

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

AUGMENTIN is indicated in the treatment of the following infections when caused by AUGMENTIN sensitive, beta-lactamase producing organisms: Skin and Skin Structure Infections, including cases caused by beta-lactamase producing S. aureus, E. coli and Klebsiella spp. (only some strains may be sensitive). Urinary Tract Infections, including cases caused by beta-lactamase producing E. coli, P. mirabilis & Klebsiella spp. Upper Respiratory Tract Infections, such as sinusitis, including cases caused by beta-lactamase producing H.influenzae and M.catarrhalis, and otitis media, especially cases caused by beta-lactamase producing H. influenzae, M. catarrhalis and S. aureus. Lower Respiratory Tract Infections, especially cases caused by beta-lactamase producing H.influenzae and M.catarrhalis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to AUGMENTIN. 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 AUGMENTIN should not require the addition of another antibiotic due to the amoxicillin content of AUGMENTIN.

Product summary:

Visual Identification: White to off-white free flowing powder; Container Type: Bottle; Container Material: Glass Type III Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-10-25

Patient Information leaflet

1
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 is no evidence that
AUGMENTIN SYRUP is addictive.
BEFORE YOU GIVE
AUGMENTIN SYRUP
_ _
_AUGMENTIN SYRUP MUST _
_NOT BE GIVEN IF: _

your child is allergic to
penicillin or similar types of
antibiotics (such as
cephalosporins) or any of the
ingredients contained in
AUGMENTIN SYRUP. If your
child has ever had an allergic
reaction (s

Summary of Product characteristics

1
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, colloidal anhydrous silica, 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
achieved 60 to 120 minutes
after dosing.
Following oral administration of Augmentin 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 Augmentin Forte syrup
2
16.6 mg/Kg,(amoxycillin 13.3mg/Kg + clavulanic acid 3.3mg/Kg) the
means of peak values were