FLIXOTIDE

What it is

FLIXOTIDE contains fluticasone propionate. It is supplied as a powder for inhalation in a metered inhaler device. FLIXOTIDE is available in multiple formulations, including ACCUHALER and CFC-free inhalation aerosol variants.

Approved indications

— Regular treatment of asthma, where the use of a combination product is appropriate.

Dosing overview

The dose of fluticasone propionate should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be given the dose containing the appropriate fluticasone propionate dosage for the severity of their disease. For adults and children over 12 years, the recommended dose for regular asthma management is 100 to 500 micrograms fluticasone propionate twice daily. The recommended dose for initiation of maintenance therapy in moderate persistent asthma is 100 micrograms fluticasone propionate twice daily. FLIXOTIDE should not be used in children younger than 12 years.

Key safety warnings

FLIXOTIDE is not for relief of acute symptoms for which a fast- and short-acting inhaled bronchodilator (such as salbutamol) is required. Patients should be advised to have their relief medication available at all times. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should be reviewed by a physician. Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation; therapy should be titrated-down under physician supervision. FLIXOTIDE should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Cardiovascular effects, such as increases in systolic blood pressure and heart rate, may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses. For this reason, FLIXOTIDE should be used with caution in patients with pre-existing cardiovascular disease. A drug interaction study has shown that ritonavir can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects. Possible systemic effects include Cushing's syndrome, Cushingoid features, depression of the hypothalamic-pituitary adrenal axis, reduction of bone mineral density, cataract, glaucoma and retardation of growth rate in children and adolescents.

Contraindications

FLIXOTIDE is contraindicated in patients with a history of hypersensitivity to any ingredients of the preparation.

PBS listing

FLIXOTIDE is listed on the PBS in multiple strengths including 50 micrograms, 100 micrograms, 125 micrograms, 250 micrograms and 500 micrograms per dose. The 50 microgram pressurised inhalation (120 doses) is listed with streamlined restriction at an ex-manufacturer price of A$10.61. The 100 microgram powder formulation (60 doses) is listed with unrestricted and restricted items at A$9.17. The 125 microgram pressurised inhalation (120 doses) is listed with restricted and unrestricted items at A$15.18. The 250 microgram powder formulation (60 doses) is listed with unrestricted and restricted items at A$16.11, while the 250 microgram pressurised inhalation (120 doses) is listed unrestricted at A$25.59. The 500 microgram powder formulation (60 doses) is listed unrestricted at A$22.80.

Regulatory history

FLIXOTIDE ACCUHALER formulations containing 100 micrograms, 250 micrograms and 500 micrograms of fluticasone propionate were first listed on the ARTG on 8 January 1997. CFC-free formulations containing 125 micrograms and 250 micrograms per dose were first listed on 13 July 1998. The FLIXOTIDE JUNIOR CFC-FREE INHALER containing 50 micrograms per actuation was first listed on 24 January 2001.