CILAMOX SUGAR-FREE SYRUP (amoxicillin 250mg/5mL as trihydrate) powder for oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 50 mg/mL

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: colloidal anhydrous silica; silicon dioxide; disodium edetate; sodium benzoate; xanthan gum; saccharin sodium; sorbitol; Flavour

Administration route:

Oral

Units in package:

100mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 6 NOVEMBER 2003: Cilamox is indicated for the treatment of infections due to susceptible strains of the sensitive organisms. Gram-negative: H. influenzae, E coli, Pr. mirabilis, and N. gonorrhoeae. Gram-positive: Streptococcus species, S. pneumoniae, non-penicllinase producing Staphlococci and Bacillus anthracis. Note 1: Cilamox may be useful in instituting therapy prior to bacteriology; however, bacteriological studies to determine the causative organisms and their sensitivity to Cilamox should be performed. Note 2: Penicillins are now generally regarded only as adjunctive to some other established first-line antibiotic therapy in the treatment and post-exposure prophylaxis of anthrax, because of concerns of constitutive and inducible beta-lactamase in Bacillus anthracis. If use of amoxycillin is contemplated, appropriate bacteriological studies must be performed by a reliable and established test method. Amoxycillin may then be suitable if the specific B. anthracis strain has been shown definitively to be sensitive to penicillin/amaxycillin.

Product summary:

Visual Identification: A white to off-white free flowing powder with a characteristic fruity odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1997-02-11

Patient Information leaflet

CILAMOX capsules and syrup - CMI
Page 1 of 3
CILAMOX
_amoxicillin (as amoxicillin trihydrate) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
CILAMOX. It does not contain all
the available information.
It does not take place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using CILAMOX
against the benefits this medicine
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CILAMOX IS
USED FOR
CILAMOX contains amoxicillin (as
amoxicillin trihydrate) as the
active ingredient and is an
antibiotic that belongs to the
group of medicines called
penicillins.
It is used to treat infections in
different parts of the body caused
by bacteria.
CILAMOX works by killing the
bacteria that are causing the
infection. It can also be used to
prevent infection.
CILAMOX will not work against
infections caused by viruses such
as colds or flu.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS
ABOUT WHY CILAMOX HAS BEEN
PRESCRIBED FOR YOU.
Your doctor however, may have
prescribed it for another purpose.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CILAMOX IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
medicines containing
amoxicillin trihydrate
•
penicillin or any other similar
antibiotics such as
cephalosporins
•
any of the ingredients listed at
the end of this leaflet.
Some symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the
face, lips, mouth or throat which
may cause difficulty swallowing or
breathing; wheezing or shortness
of breath.
TELL YOUR DOCTOR IF YOU HAVE
SUFFERED FROM ANY OF THE
ALLERGIC CONDITIONS IN THE PAST
DUE TO THE USE OF PENICILLIN.
DO NOT USE CILAMOX IF THE
PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT USE IT IF THE EXPIRY DATE
PRINTED ON THE PACK HAS
PASSED.
TALK TO YOUR DOCTOR IF YOU A

Summary of Product characteristics

CILAMOX – Product Information
Page 1 of 8
PRODUCT INFORMATION
CILAMOX
NAME OF THE MEDICINE
CILAMOX
CAPSULES
contain 250 mg and 500 mg of amoxicillin as the trihydrate.
CILAMOX
SUSPENSIONS
contain 125 mg/5mL and 250 mg/5mL of amoxicillin as the
trihydrate.
The structural formula of Amoxicillin trihydrate
_ _
is:
Molecular formula
C
16
H
19
N
3
O
5
S.3H
2
O and molecular weight 419.5.
SOLUBILITY
: Slightly soluble in water and ethanol (96%); practically insoluble
in chloroform,
ether and fixed oils. It dissolves in dilute solutions of acids and of
alkali hydroxides.
DESCRIPTION
Cilamox contains as the active ingredient the semisynthetic antibiotic
amoxicillin.
Chemically
amoxicillin
trihydrate
is
D-(-)-
α
-amino-
ρ
-hydroxybenzylpenicillin
trihydrate
which is susceptible to hydrolysis by
β
-lactamases.
EXCIPIENTS
CILAMOX
capsules
250 MG
capsules contain gelatin, titanium dioxide, magnesium stearate and
talc.
CILAMOX
capsules 500 MG
capsules contain gelatin, titanium dioxide,magnesium stearate and
talc.
CILAMOX 125 MG/5 ML
contains sorbitol, disodium edetate, sodium benzoate, silicon dioxide,
silica-colloidal anhydrous, xanthan gum, saccharin sodium and the
following flavours -
Banana 51464 AP0572 (ARTG NO. 2737) & Forestberry 502874 AP0572 (ARTG
No. 2738).
CILAMOX 250 MG/5 ML
contains sorbitol, disodium edetate, sodium benzoate, silicon dioxide,
HO
NH
2
H
O
NH
N
H
H
O
S
CH
3
CH
3
H
COOH
,3H
2
O
CILAMOX – Product Information
Page 2 of 8
colloidal anhydrous silica, xanthan gum, saccharin sodium and the
following flavours –
Sonaflo Passionfruit 171011 and Sonaflo Vanilla 080911.
PHARMACOLOGY
Cilamox is stable in the presence of gastric acid and is rapidly and
well absorbed after oral
administration, even in the presence of food. It diffuses rapidly into
most body tissues and
fluids, with the exception of brain and spinal fluid except when the
meninges are inflamed.
Cilamox has been shown to diffuse into sputum and saliva and is
excreted mainly via the
urine where it exists in high concentration. The amount to