SALPLUSF

What it is

SalplusF is a pressurised metered dose inhalation containing fluticasone propionate and salmeterol (as xinafoate). It is available in two strengths: 125/25 micrograms and 250/25 micrograms per actuation. The suspension is contained in an aluminium canister with a metering valve and a polypropylene actuator with a dose indicator that shows the number of actuations left in the canister through a window.

Approved indications

— For the regular treatment of asthma, where the use of a combination product is appropriate. — For patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. — For patients who are symptomatic on current inhaled corticosteroid therapy. — For the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (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 SalplusF is not for use in patients aged under 12 years.

SalplusF must be used regularly for optimum benefit, even when asymptomatic. Patients should be regularly assessed by a doctor so the dose they are receiving remains optimal. There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.

Key safety warnings

SalplusF 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. There was an increased reporting of pneumonia in studies of patients with COPD receiving fluticasone propionate/salmeterol. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap. 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, SalplusF should be used with caution in patients with pre-existing cardiovascular disease. A transient decrease in serum potassium may occur with all sympathomimetic drugs at higher therapeutic doses. Therefore, SalplusF should be used with caution in patients predisposed to low levels of serum potassium. A drug interaction study showed that ritonavir can greatly increase fluticasone propionate plasma 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. Concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit outweighs the risk of systemic corticosteroid side-effects.

Contraindications

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

PBS listing

The provided sources do not contain information regarding PBS listing for SalplusF.

Regulatory history

SalplusF was first approved on 15 December 2016. The 125/25 microgram and 250/25 microgram inhalation pressurised aerosol can metered dose formulations were first listed on the ARTG on 15 December 2016. Subsequently, the 250/50 microgram dry powder inhaler formulation was listed on 3 January 2024, and the 500/50 microgram powder for inhalation formulation was listed on 1 February 2024.