AXOTIDE

What it is

Fluticasone + Salmeterol Cipla is a pressurised metered dose inhalation containing fluticasone propionate and salmeterol (as salmeterol xinafoate), available in two strengths: 125 micrograms of fluticasone propionate with 25 micrograms of salmeterol, and 250 micrograms of fluticasone propionate with 25 micrograms of salmeterol. The 125/25 formulation is supplied in a rigid aluminium container with a white actuator and pink cap, while the 250/25 formulation has a white actuator and rubin red cap, with both featuring a dose indicator. Fluticasone propionate provides potent anti-inflammatory activity that improves lung function and prevents exacerbations, while salmeterol provides symptomatic relief. The combination offers a more convenient regimen for patients on concurrent long-acting beta-agonist and inhaled corticosteroid therapy.

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 and patients who are symptomatic on current inhaled corticosteroid therapy. — Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy.

Dosing overview

Fluticasone + Salmeterol Cipla is not for use in patients aged under 12 years. For 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 appropriate strength for the severity of their disease. The recommended dose for regular asthma management is 100/50 microgram to 500/50 microgram fluticasone propionate/salmeterol twice daily, delivered as two inhalations twice daily. For COPD, the recommended dose is two inhalations of 250/25 micrograms twice daily, although two inhalations of 125/25 micrograms twice daily may be considered in patients at greater risk of inhaled corticosteroid adverse effects. There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.

Key safety warnings

Fluticasone propionate/salmeterol 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 indicates deterioration of control and sudden progressive deterioration in asthma control is potentially life threatening; patients should be reviewed by a physician in both cases. 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 as clinical features frequently overlap with exacerbation. Fluticasone propionate/salmeterol 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 occur with sympathomimetic drugs, especially at higher than therapeutic doses, and fluticasone propionate/salmeterol should be used with caution in patients with pre-existing cardiovascular disease. A transient decrease in serum potassium may occur with sympathomimetic drugs at higher therapeutic doses, and caution is advised in patients predisposed to low serum potassium levels. Rare instances of glaucoma and increased intraocular pressure have been reported following inhaled corticosteroids, and patients presenting with a change in vision should be considered for referral to an ophthalmologist. Fluticasone propionate/salmeterol should not be initiated in patients with unstable or acutely deteriorating asthma, as serious acute respiratory events including fatalities have been reported when salmeterol has been initiated in this situation. A large US study showed a significant increase in asthma-related deaths in patients receiving salmeterol, with data suggesting that African-American patients may be at greater risk of serious respiratory-related events or deaths when using salmeterol compared to placebo. Concomitant use of salmeterol with strong CYP3A4 inhibitors (such as ketoconazole, atazanavir, ritonavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir or saquinavir) is not recommended due to potential increased risk of cardiovascular adverse events. Ritonavir, a highly potent cytochrome P450 3A4 inhibitor, can greatly increase fluticasone propionate plasma concentrations and reduce serum cortisol, and concomitant use should be avoided unless the potential benefit outweighs the risk of systemic corticosteroid side-effects.

Contraindications

Fluticasone + Salmeterol Cipla is contraindicated in patients with a history of hypersensitivity to any ingredients of the preparation.

PBS listing

Information on the PBS listing for AXOTIDE is not provided in the source documents.

Regulatory history

AXOTIDE CFC-Free fluticasone propionate 250 microgram/dose inhalation metered dose aerosol can and AXOTIDE CFC-Free fluticasone propionate 125 microgram/dose inhalation metered dose aerosol can were first listed on the ARTG on 11 March 2016. In November 2017, the PBAC recommended an amendment to the PBS listing to allow fluticasone propionate + salmeterol to be used as maintenance therapy for asthma in adult and adolescent patients.