CILAMOX SUGAR FREE SYRUP amoxicillin 125mg/5mL (as trihydrate) powder for oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 25 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: 1 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1997-02-11

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