SEROFLO

What it is

SEROFLO contains fluticasone propionate and salmeterol xinafoate . It is a powder for inhalation in a metered inhaler device . SEROFLO is available in two strengths: 250/50 micrograms and 500/50 micrograms of fluticasone propionate and salmeterol respectively .

Approved indications

— Regular treatment of asthma in patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids, or in 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

The dose of fluticasone propionate should be titrated to the lowest dose at which effective control of symptoms is maintained . There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment .

Key safety warnings

SEROFLO 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 . Sudden and progressive deterioration in control of asthma is potentially life threatening and consideration should be given to increasing corticosteroid therapy . Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation; therapy should be titrated-down under physician supervision . 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 . SEROFLO 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, SEROFLO should be used with caution in patients with pre-existing cardiovascular disease . Rare instances of glaucoma and increased intraocular pressure have been reported following administration of inhaled corticosteroids. If a patient presents with a change in vision, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy . Patients should rinse the mouth out with water and/or brush teeth after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush .

Contraindications

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

Regulatory history

SEROFLO CIPHALER 250/50 and SEROFLO MULTIHALER 250/50 were first registered on the ARTG on 12 August 2021 . SEROFLO CIPHALER 500/50 and SEROFLO MULTIHALER 500/50 were first registered on the ARTG on 29 September 2022 .