Amoxil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Amoxicillin trihydrate 294.118mg equivalent to amoxycillin 250 mg; Amoxicillin trihydrate 292.4mg equivalent to amoxycillin 250 mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Amoxicillin trihydrate 294.118 mg (equivalent to amoxycillin 250 mg)

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Amoxicillin trihydrate 294.118mg equivalent to amoxycillin 250 mg Excipient: Gelatin Iron oxide red Iron oxide yellow Magnesium stearate Titanium dioxide Active: Amoxicillin trihydrate 292.4mg equivalent to amoxycillin 250 mg Excipient: Erythrosine Gelatin Indigo carmine Iron oxide yellow Magnesium stearate Titanium dioxide

Units in package:

Blister pack, PVC/Al, 20 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Beecham Pharmaceuticals (PTE) Ltd

Therapeutic indications:

For the treatment of infections due to susceptible organisms.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 20 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 capsules - 60 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 500 capsules - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1972-10-18

Summary of Product characteristics

                                1 
NEW ZEALAND  
DATA SHEET 
 
AMOXIL
®
 
_AMOXYCILLIN TRIHYDRATE _
PRESENTATION 
AMOXIL Paediatric Drops:  Fruit flavoured suspension
providing 125mg amoxycillin per 
1.25mL (measured by the pipette
supplied).  Presented as powder in bottles for preparing 
20mL. 
 
AMOXIL Syrups:  Fruit flavoured sugar free syrup
providing 125mg or 250mg amoxycillin 
per 5mL.  Presented as powder in bottles for preparing 100mL. 
 
AMOXIL Capsules 250mg: hard gelatine
capsule containing 250mg amoxycillin with red 
opaque cap/yellow opaque body, marked GS LEX in white
ink filled with white granular 
powder. Packs of 20 or 100. 
 
AMOXIL Capsules 500mg: hard gelatine
capsule containing 500mg amoxycillin with red 
opaque cap/yellow opaque body, marked GS JVL in white ink filled
with white granular 
powder. Packs of 20 or 100. 
 
 
INDICATIONS 
AMOXIL should be used in accordance with
local antibiotic-prescribing information 
guidelines and local susceptibility data. 
 
Treatment of Infection:  AMOXIL is indicated in the
treatment of infections due to 
susceptible organisms. 
 
AMOXIL may be useful in instituting therapy prior to
bacteriology; however bacteriological 
studies to determine the causative
organisms and their sensitivity to AMOXIL should be 
performed. 
 
Prophylaxis for endocarditis:  AMOXIL may be
used for the prevention of bacteraemia, 
associated with procedures such as dental extraction, in
patients at risk of developing 
bacterial endocarditis. 
 
Susceptibility to amoxicillin will vary with geography and time
and local susceptibility data 
should be consulted where
available and microbiological sampling and susceptibility 
testing performed where necessary (see
Further Information, Pharmacodynamic 
properties). 
 
 
 
2 
DOSAGE AND ADMINISTRATION 
UPPER RESPIRATORY TRACT INFECTIONS (DUE TO
STREPTOCOCCI, PNEUMOCOCCI, NON
                                
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