Amoxil Paediatric Drops
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
01-11-2013
Send request.
Active ingredient:
Amoxicillin trihydrate 113.955 mg/mL equivalent to Amoxycillin 100 mg/mL ((6% overage also added - amount used based on potency)); ; ; Amoxicillin trihydrate 116.96 mg/mL equivalent to amoxcillin 100 mg/mL
Available from:
GlaxoSmithKline NZ Limited
INN (International Name):
Amoxicillin trihydrate 113.955 mg/mL (=Amoxycillin 100 mg/mL; (6% overage also added - amount used based on potency))
Dosage:
100 mg/mL
Pharmaceutical form:
Powder for oral suspension
Composition:
Active: Amoxicillin trihydrate 113.955 mg/mL equivalent to Amoxycillin 100 mg/mL ((6% overage also added - amount used based on potency)) Excipient: Carmellose sodium Lemon flavour 15.81.4309 Peach flavour 15.81.4447 Sodium benzoate Strawberry flavour 15.81.4607 Sucrose Active: Amoxicillin trihydrate 116.96 mg/mL equivalent to amoxcillin 100 mg/mL Excipient: Aspartame Carmellose sodium Crospovidone Silica hydrophobic colloidal Lemon-Peach-Strawberry flavour Magnesium stearate Sodium benzoate Xanthan gum
Units in package:
Bottle, glass, with graduated pipette, 20 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
SmithKline Beecham Quimica, SA de CV
Therapeutic indications:
Amoxil is indicated for the treatment of infections due to susceptible organisms.
Product summary:
Package - Contents - Shelf Life: Bottle, glass, with graduated pipette - 20 mL - 36 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
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
Read the complete document
