OXIS TURBUHALER

What it is

OXIS TURBUHALER is formoterol fumarate dihydrate powder for inhalation in hard capsules. Formoterol belongs to a new class of potent, long-acting, selective β2-adrenoceptor agonists. It exerts a bronchodilator effect in patients with reversible airways obstruction.

Approved indications

— Long-term, regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma) in patients aged 5 years or more who are receiving inhaled or oral corticosteroids. — Prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD).

Dosing overview

For asthma, OXIS TURBUHALER should only be prescribed as an add-on to an inhaled corticosteroid.

Key safety warnings

OXIS TURBUHALER should not be initiated in patients with unstable or acutely deteriorating asthma. OXIS TURBUHALER should not be used for the management of acute episodes or exacerbation of asthma. OXIS TURBUHALER should not be used in conjunction with another long-acting β2 adrenoceptor agonist. Clinical studies with OXIS TURBUHALER suggested a higher incidence of serious asthma exacerbations in patients who received OXIS TURBUHALER than those who received placebo. More children who received OXIS TURBUHALER 24 μg twice daily (11/171, 6.4%) or OXIS TURBUHALER 12 μg twice daily (8/171, 4.7%) than children who received placebo (0/176, 0.0%) experienced serious asthma exacerbations. Potentially serious hypokalaemia may result from β2-adrenoceptor agonist therapy, including OXIS TURBUHALER, with particular caution advised in severe asthma as this effect may be potentiated by hypoxia and concomitant medications. It is recommended that serum potassium levels be monitored in such situations. Formoterol, the active ingredient of OXIS TURBUHALER, belongs to the class of long-acting β2-adrenoceptor agonists. In a study with salmeterol, a different long-acting β2-agonist, a higher rate of death due to asthma was observed in the patients treated with salmeterol (13/13176) than in the placebo group (3/13179). No study adequate to determine whether the rate of asthma related death is increased with OXIS TURBUHALER has been conducted.

Contraindications

Hypersensitivity to any ingredients of the preparation. OXIS TURBUHALER capsules contain lactose. Therefore, patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not take this medicine.

PBS listing

OXIS TURBUHALER is listed on the PBS in two strengths: 12 micrograms per dose (60 doses) with ex-manufacturer price A$15.34, and 6 micrograms per dose (60 doses) with ex-manufacturer price A$10.20. Both listings are restricted.

Regulatory history

OXIS TURBUHALER 12 and OXIS TURBUHALER 6 were first listed on the ARTG on 1997-11-10. The product information was approved by the TGA on 20 July 2005 and revised on 23 June 2025.