SYMBICORT

What it is

Symbicort Rapihaler is a pressurised metered dose inhaler containing budesonide and formoterol fumarate dihydrate. Four strengths are registered: Symbicort Rapihaler 50/3 (delivering 40 μg budesonide and 2.25 μg formoterol per inhalation), 100/3 (80 μg budesonide and 2.25 μg formoterol), 100/6 (80 μg budesonide and 4.5 μg formoterol), and 200/6 (160 μg budesonide and 4.5 μg formoterol).

Approved indications

— Treatment of asthma in adults and adolescents 12 years and older to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations. — Symptomatic treatment of moderate to severe chronic obstructive pulmonary disease (COPD) with FEV₁ ≤50% predicted normal in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations (Symbicort Rapihaler 200/6 only).

Dosing overview

Symbicort Rapihaler is indicated in adults and adolescents 12 years and older and is not recommended for children below 12 years of age. For asthma, dosing varies by treatment approach. For anti-inflammatory reliever therapy, patients should take 2 inhalations of Symbicort Rapihaler 100/3 as needed in response to symptoms, with an additional 2 inhalations if symptoms persist after a few minutes; no more than 12 inhalations should be taken on any single occasion, and a total daily dose of more than 16 inhalations is normally not needed, though up to 24 inhalations can be used temporarily. For anti-inflammatory reliever plus maintenance therapy, patients also take a recommended maintenance dose of 4 inhalations per day given as 2 inhalations in the morning and evening or 4 inhalations in either the morning or evening, with some patients requiring 4 inhalations of Symbicort Rapihaler 100/3 twice daily; the maintenance dose should be titrated to the lowest dose at which effective asthma control is maintained. For fixed-dose maintenance therapy, Symbicort Rapihaler 50/3 is given as 2 or 4 inhalations twice daily with a maximum of 8 inhalations daily (400 μg budesonide/24 μg formoterol), and Symbicort Rapihaler 100/3 is given as 2 or 4 inhalations twice daily with a maximum of 8 inhalations daily (800 μg budesonide/24 μg formoterol). Symbicort Rapihaler 200/6 is given as 2 inhalations twice daily with a maximum of 4 inhalations daily (800 μg budesonide/24 μg formoterol), though for adults 18 years and over requiring higher doses, the maximum may be increased to 4 inhalations twice daily (1600 μg budesonide/48 μg formoterol). For COPD, Symbicort Rapihaler 200/6 is given as 2 inhalations twice daily with a maximum daily dose of 4 inhalations (800 μg budesonide/24 μg formoterol).

Key safety warnings

Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and requires urgent medical assessment, with consideration given to increased corticosteroid therapy or antibiotic treatment if bacterial infection is present. In higher than recommended doses, inhaled corticosteroids may have adverse systemic effects including Cushing's syndrome, Cushingoid features, depression of the HPA axis, reduction of bone density, cataract, glaucoma, and retardation of growth rate in children and adolescents, though these effects are much less likely with inhaled corticosteroids than with oral corticosteroids. Very rare cases of clinically relevant adrenal dysfunction have been reported in patients using inhaled budesonide at recommended doses, and clinically important disturbances of the HPA axis may occur in patients switched from oral corticosteroids or administering concomitant medication metabolised by CYP3A4. Visual disturbance may be reported with corticosteroid use, and patients presenting with blurred vision or other visual disturbances should be considered for ophthalmologist referral to evaluate possible causes including cataract, glaucoma, or central serous chorioretinopathy. High doses of beta-2 agonists can lower serum potassium, potentially resulting in serious hypokalaemia, with particular caution advised in acute exacerbation as the associated risk may be augmented by hypoxia. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as pneumonia has been reported following the administration of inhaled corticosteroids.

Contraindications

Hypersensitivity to budesonide, formoterol or any other ingredients present in the formulation is a contraindication.

Regulatory history

Symbicort Rapihaler 100/6 and 200/6 were first listed on the ARTG on 22 February 2006. Symbicort Rapihaler 100/3 was first listed on 26 July 2012. An Australian Public Assessment Report was approved on 6 December 2011 for use of Symbicort Rapihaler for treatment of asthma where combination therapy with inhaled corticosteroid and long-acting beta-2 agonist is appropriate in adults and adolescents, and for symptomatic treatment of moderate to severe COPD. In November 2019, the PBAC recommended Symbicort Rapihaler for first-line treatment of mild asthma as an anti-inflammatory reliever therapy with a streamlined authority required restriction, cost-minimised to inhaled corticosteroid maintenance regimen plus short-acting beta-2 agonist.