Salmeterol/Fluticasone propionate

ATC code

R03AK06

Therapeutic class

Adrenergic and inhaled corticosteroid (combination) · Long-acting beta-2 agonist (LABA) + Inhaled corticosteroid (ICS)

Forms

inhalation powder, inhalation aerosol

Brand names

Airflusal Forspiro (ES) · Seffalair Spiromax (EU) · Advair Diskus (US) · Advair HFA (US) · Seretide (EU)

Overall confidence

high

Regulatory sources consulted

ema-epar-EMEA/H/C/004881
aemps-cima-80248
crediblemeds.org
professional-knowledge-base
RxNorm rxcui 284635 ↗

Approved indications

Regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2-agonists.
Symptomatic treatment of patients with COPD, with a FEV1 <60% of normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Contraindications

Absolute

Hypersensitivity to the active substances or to any of the excipients (e.g., lactose, which may contain milk proteins).

Clinical warnings

Boxed warning · Long-acting beta2-adrenergic agonists (LABA) such as salmeterol increase the risk of asthma-related death. Available data suggest that this risk is reduced with the concomitant use of an inhaled corticosteroid (ICS). — FDA
Major warning · Increased risk of pneumonia in patients with COPD. Patients should be monitored for signs and symptoms of pneumonia. — EMA

Drug interactions

HighRitonavirJ05AE03
Mechanism: Potent inhibition of CYP3A4, markedly increasing plasma concentration of fluticasone propionate.
Recommendation: Concomitant use is not recommended. Increases risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
EMA SPC
ModerateNon-selective beta-blockersC07A
Mechanism: Pharmacodynamic antagonism. Beta-blockers may antagonize the bronchodilator effect of salmeterol and induce severe bronchospasm.
Recommendation: Avoid use of non-selective beta-blockers in patients with asthma or COPD. Cardioselective beta-blockers should be used with caution.
EMA SPC

Adverse events

Common (≥1%)

headache · nasopharyngitis · oral and pharyngeal candidiasis · hoarseness · bruising

Rare but serious

pneumonia · hypersensitivity reactions · paradoxical bronchospasm · systemic corticosteroid effects · cardiac arrhythmias

Pregnancy and lactation

FDA category: C (Legacy)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether it is excreted in human milk; a decision should be made whether to discontinue nursing or to discontinue the drug.