AMOXICILLIN MLABS amoxicillin (as trihydrate) 250 mg/5 mL powder for oral suspension bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 57.4 mg/mL (Equivalent: amoxicillin, Qty 50 mg/mL)

Available from:

Micro Labs Pty Ltd

Pharmaceutical form:

Suspension, powder for

Composition:

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

Administration route:

Oral

Units in package:

Amoxicillin powder for oral suspension packed in bottle of 150mL along with 28mm screw cap

Prescription type:

(S4) Prescription Only Medicine

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 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,Respiratory (Acute and Chronic): H.influenzae, Streptococcus; S.pneumoniae; staphylococcus, non-penicillinase-producing; E.coli,Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): E.coli, P.mirabilis and S.faecalis.,Gonorrhoea: N.gonorrhoeae (non-penicillinase producing).,Prophylaxis of endocarditis: [Trade name] 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: Unconstituted powder: white to pale yellow free flowing powder. Reconstituted: pale yellow to yellow coloured suspension with fruity aromatic odor.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-04-08

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - AMOXICILLIN MLABS (AMOXICILLIN
TRIHYDRATE)
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every 5 ml of oral suspension contains amoxicillin
trihydrate equivalent
to 125 mg amoxicillin (25 mg per ml) for strength 125mg/5mL Oral
suspension
When reconstituted, every 5 ml of oral suspension contains amoxicillin
trihydrate equivalent
to 250 mg amoxicillin (50 mg per ml) for strength 250mg/5mL Oral
suspension.
Amoxicillin MLabs contains the inactive ingredients Sodium benzoate
and sorbitol.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Dry Powder for oral suspension.
White to pale yellow free flowing powder for Oral suspension, which
when constituted with
water forms Pale yellow to yellow colored suspension with fruity
aromatic odor.
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 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)).
2
Respiratory
(Acute
and
Chronic):
_H.influenzae_,
Streptococcus;
_S.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 S.faecalis. _
Gonorrhoea: _N.gonorrhoeae_ (non-penicillinase producing).
Prophylaxis