SERETIDE

What it is

SERETIDE is a metered dose inhaler (MDI) containing fluticasone propionate and salmeterol xinafoate, supplied in two strengths: 125 or 250 micrograms of fluticasone propionate and 25 micrograms of salmeterol per single actuation. The canister contains a white to off-white suspension. SERETIDE contains fluticasone propionate and salmeterol xinafoate which have differing modes of action; salmeterol provides symptomatic relief, while fluticasone propionate improves lung function and prevents exacerbations of the condition.

Approved indications

— Regular treatment of asthma where the use of a combination product is appropriate, including patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids, patients who are symptomatic on current inhaled corticosteroid therapy, and initiation of maintenance therapy in patients with moderate persistent asthma not adequately controlled on as-needed reliever medication who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day. — Symptomatic treatment of patients with severe COPD (FEV1 less than 50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy.

Dosing overview

**Asthma** The dose of fluticasone propionate should be titrated to the lowest dose at which effective control of symptoms is maintained, with patients given the dose of SERETIDE 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 100/50 micrograms to 500/50 micrograms fluticasone propionate/salmeterol twice daily, delivered as two inhalations (50/25 micrograms to 250/25 micrograms) twice daily. The recommended dose for initiation of maintenance therapy in moderate persistent asthma is 100/50 micrograms fluticasone propionate/salmeterol twice daily, delivered as two inhalations (50/25 micrograms) twice daily. For children 4 years and over, the recommended dose for regular asthma management is 100/50 micrograms fluticasone propionate/salmeterol twice daily, delivered as two inhalations (50/25 micrograms) twice daily. **COPD** For adults with COPD, the recommended dose is 250/50 micrograms or 500/50 micrograms fluticasone propionate/salmeterol twice daily, delivered as two inhalations 250/25 micrograms twice daily, or two inhalations 125/25 micrograms twice daily as a consideration in patients at greater risk of inhaled corticosteroid adverse effects.

Key safety warnings

SERETIDE is not for relief of acute symptoms for which a fast- and short-acting inhaled bronchodilator such as salbutamol is required, and 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 requires physician review, and sudden and progressive deterioration in control of asthma is potentially life threatening. There was an increased reporting of pneumonia in studies of patients with COPD receiving fluticasone propionate/salmeterol, and physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap. SERETIDE should not be initiated in patients with unstable or acutely deteriorating asthma, which may be a life-threatening condition, as serious acute respiratory events including fatalities have been reported when salmeterol has been initiated in this situation. A drug interaction study has shown that ritonavir can greatly increase fluticasone propionate plasma concentrations, and 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 should be avoided unless the potential benefit outweighs the risk.

Contraindications

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

PBS listing

Information regarding SERETIDE's PBS listing, including strength, item count, restriction type and ex-manufacturer price, is not available in the provided documents.

Regulatory history

SERETIDE ACCUHALER formulations (100/50, 250/50 and 500/50 micrograms) were first listed on the Australian Register of Therapeutic Goods on 8 February 2000. SERETIDE MDI formulations (50/25, 125/25 and 250/25 micrograms) were first listed on the Australian Register of Therapeutic Goods on 26 September 2005.