APO-AMOXYCILLIN amoxicillin (as trihydrate) 125mg/5mL powder for suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 28.9 mg/mL (Equivalent: amoxicillin, Qty 25 mg/mL)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amoxicillin trihydrate

Pharmaceutical form:

Suspension, powder for

Composition:

Excipient Ingredients: sunset yellow FCF; colloidal anhydrous silica; xanthan gum; saccharin sodium; sodium citrate dihydrate; sorbitol; Flavour

Administration route:

Oral

Units in package:

100mL when reconstituted

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms. Note. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. Skin and skin structure: Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see section 5.1 Pharmacodynamic Properties - Microbiology). Respiratory (acute and chronic): H. influenzae; Streptococcus; Strep. pneumoniae; Staphylococcus, nonpenicillinase producing; E. coli (see section 5.1 Pharmacodynamic Properties - Microbiology). Genitourinary tract (complicated and uncomplicated, acute and chronic): E. coli (see section 5.1 Pharmacodynamic Properties - Microbiology), P. mirabilis and Strep. faecalis. Gonorrhoea: N.gonorrhoeae (nonpenicillinase producing). Prophylaxis of endocarditis: Amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

Product summary:

Visual Identification: White to off-white powder forming an orange suspension upon reconstitution with water; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-08-07

Patient Information leaflet

APO-AMOXYCILLIN SUSPENSION
1
APO-AMOXYCILLIN
SUSPENSION
_Amoxicillin (as trihydrate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
GIVING YOUR CHILD THIS MEDICINE.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU DO NOT UNDERSTAND ANYTHING OR
ARE WORRIED ABOUT YOUR CHILD
TAKING THIS MEDICINE.
This leaflet answers some common
questions about amoxicillin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available. Speak to your pharmacist
or doctor to obtain the most up to
date information on the medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of using this medicine
against the benefits they expect it
will have.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your child's medicine is
APO-Amoxycillin Suspension. It
contains a penicillin called
amoxicillin (as trihydrate) as the
active ingredient.
It is an antibiotic which used to treat
infections in different parts of the
body caused by bacteria.
Amoxicillin can also be used to
prevent infection.
Amoxicillin will not work against
infections caused by viruses such as
colds or the flu.
_HOW IT WORKS _
Amoxicillin is an antibiotic that
belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that are
causing your child's infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR CHILD.
Your doctor may have prescribed
amoxicillin for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
Amoxicillin suspension is the most
suitable form of amoxicillin to give
to children.
If you are an adult and you a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-AMOXYCILLIN (AMOXICILLIN TRIHYDRATE) POWDER
FOR SUSPENSION
1
NAME OF THE MEDICINE
Amoxicillin (as amoxicillin trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL contains 125 mg or 250 mg amoxicillin (as trihydrate).
EXCIPIENTS WITH KNOWN EFFECT
Saccharin, sodium, sorbitol
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-AMOXYCILLIN POWDER FOR SUSPENSION 125MG/5ML
White to off-white powder forming an orange suspension upon
reconstitution with water.
APO-AMOXYCILLIN POWDER FOR SUSPENSION 250MG/5ML
White to off-white powder forming an orange suspension upon
reconstitution with water.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
It is indicated for the treatment of the following infections due to
susceptible strains of
sensitive organisms.
Note. Therapy should be guided by bacteriological studies, including
sensitivity tests, and by
clinical response. However, in emergency cases where the causative
organism has not
been identified, therapy with amoxicillin may be useful. Clinical
judgment will decide whether
combination with another antibiotic would provide a sufficiently broad
spectrum of activity
pending sensitivity test results.
SKIN AND SKIN STRUCTURE
Staphylococcus, non-penicillinase producing; Streptococcus; _E. coli_
(see section 5.1
PHARMACODYNAMIC PROPERTIES - MICROBIOLOGY).
RESPIRATORY (ACUTE AND CHRONIC)
_H. influenzae_; Streptococcus; _Strep. pneumoniae_; Staphylococcus,
non-penicillinase
producing; _E. coli_ (see section 5.1 PHARMACODYNAMIC PROPERTIES -
MICROBIOLOGY).
GENITOURINARY TRACT (COMPLICATED AND UNCOMPLICATED, ACUTE AND CHRONIC)
_E. coli_ (see section 5.1 PHARMACODYNAMIC PROPERTIES - MICROBIOLOGY),
_P. mirabilis and _
_Strep. faecalis. _
2
GONORRHOEA
_N. gonorrhoeae_ (non-penicillinase producing).
PROPHYLAXIS OF ENDOCARDITIS
Amoxicillin may be used for the prophylaxis of bacterial endocarditis
in individuals at
particular risk, such as those with a prosthetic heart valve or those
who have previou