24 months
None reported.
HFA 134a.
Toxicology has shown only those class effects typical of potent corticosteroids, and these only at doses greatly in excess of that proposed for therapeutic use. No novel effects were identified in repeat dose toxicity tests, reproductive studies or teratology studies. Fluticasone propionate is devoid of mutagenic activity in vitro and in vivo and showed no tumorigenic potential in rodents. It is both non-irritant and non-sensitising in animal models.
The non-CFC propellant, HFA 134a, has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
The use of HFA 134a as a propellant has not altered the toxicity profile of fluticasone propionate compared to that using the conventional CFC propellant.
Fluticasone propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.
In healthy subjects the mean systemic bioavailability of Flixotide Evohaler is 28.6%. In patients with asthma (FEV 1 < 75% predicted) the mean systemic absolute bioavailability was reduced by 62%. Systemic absorption occurs mainly through the lungs and has been shown to be linearly related to dose over the dose range 500 to 2000 micrograms. Absorption is initially rapid then prolonged and the remainder of the dose may be swallowed.
Absolute oral bioavailability is negligible (<1%) due to a combination of incomplete absorption from the GI tract and extensive first-pass metabolism.
87-100% of an oral dose is excreted in the faeces, up to 75% as parent compound. There is also a non-active major metabolite.
After an intravenous dose, fluticasone propionate is extensively distributed in the body. The very high clearance rate indicates extensive hepatic clearance.
10 January 2018
Glaxo Wellcome UK Ltd,
Stockley Park West,
Uxbridge,
Middlesex, UB11 1BT
Do not store above 30°C (86°F). Do not refrigerate or freeze. Protect from frost and direct sunlight.
As with most medicines in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold.
The canister should not be punctured, broken or burnt even when apparently empty.
Replace the mouthpiece cover firmly and snap into position.
An inhaler comprising an aluminium alloy can sealed with a metering valve, actuator and dust cap. Each canister contains 120 metered actuations of either 50, 125 or 250 micrograms of fluticasone propionate. (60 metered actuation hospital packs are available in the 125 or 250 microgram products).
| Flixotide 50 micrograms Evohaler Flixotide 125 micrograms Evohaler Flixotide 250 micrograms Evohaler | PL 10949/0324 PL 10949/0265 PL 10949/0266 |
The aerosol spray is inhaled through the mouth into the lungs. After shaking the inhaler the patient should exhale, the mouthpiece should be placed in the mouth and the lips closed around it. The actuator is depressed to release a spray, which must coincide with inspiration of breath.
For detailed instructions for use refer to the Patient Information Leaflet in every pack.
| Flixotide Evohaler 50 micrograms Flixotide Evohaler 125/250 micrograms | 27 June 2000 14 March 2000 |
