Flixotide

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Fluticasone propionate

Available from:

GlaxoSmithKline Australia Pty Ltd

Class:

Medicine Registered

Summary of Product characteristics

1
PRODUCT INFORMATION 

FLIXOTIDE

 JUNIOR INHALER, (CFC-FREE) INHALER, JUNIOR (CFC-FREE) INHALER, 
ACCUHALER

 AND JUNIOR ACCUHALER


AUSTRALIAN APPROVED NAME:   Fluticasone propionate 

STRUCTURE: 

CHEMICAL NAME: 

S-Fluoromethyl 6
,
9-difluoro-11ß-hydroxy-16-methyl-3-oxo-17  -propionyloxy-androsta-
1, 4-diene-17ß-carbothioate. 

MOLECULAR FORMULA:     C
25
H
31
F
3
O
5
S 

CAS: 
80474-14-2 

PHARMACOLOGY: 

PHARMACODYNAMICS: 

MODE OF ACTION: 

Fluticasone propionate given by inhalation at
recommended doses has potent glucocorticoid 
activity in the airway.  The potent anti-inflammatory action
improves the symptomatic control 
of asthma, allows reduction of other drugs, such as
rescue bronchodilators, and may limit 
the risk of decline in lung function over time.
 The low systemic bioavailability of fluticasone 
propionate provides a better risk: benefit outcome without the
adverse effects that 
accompany systemically administered corticosteroids. 

PHARMACOKINETICS: 

Following inhaled doses of 2000mcg per day (1000mcg twice daily) for
14 days in healthy 
volunteers, peak plasma concentrations of about 0.3ng/mL were
observed at 30-60 minutes 
post-dosing. 

2
ABSORPTION: 

The absolute bioavailability of fluticasone propionate for
each of the available inhaler 
devices has been estimated from within and between
study comparisons of inhaled and 
intravenous pharmacokinetic data based on AUC(0-infinity) data.
 In healthy adult subjects 
the absolute bioavailability has been estimated for Flixotide
Accuhaler (8%) and Flixotide 
Inhaler (10.9%) respectively.  Since the bioavailability
of the swallowed portion of an inhaled 
dose whic