EVOCAIR MDI

What it is

EVOCAIR MDI is a metered dose inhaler containing fluticasone propionate and salmeterol xinafoate. It is supplied as a powder for inhalation in a device metered inhaler.

Approved indications

— Regular treatment of asthma, including in 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

The dose of fluticasone propionate should be titrated to the lowest dose at which effective control of symptoms is maintained. EVOCAIR MDI should not be used in children younger than 12 years.

Key safety warnings

EVOCAIR MDI 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 sudden and progressive deterioration in control of asthma is potentially life threatening and requires review by a physician. 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. 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, and EVOCAIR MDI 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 EVOCAIR MDI should be used with caution in patients predisposed to low levels of serum potassium. EVOCAIR MDI 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.

Contraindications

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

Regulatory history

EVOCAIR MDI 125/25 and 250/25 were first registered on the ARTG on 7 May 2014.