Fluticasone

Regulatory sources consulted

• aemps-cima-ft-60480
• https://cima.aemps.es/cima/dochtml/ft/60480/FT_60480.html
• Professional clinical knowledge
• RxNorm rxcui 41126 ↗

Approved indications

• Prophylactic management of asthma in adults and children. Maintenance treatment of persistent asthma.
• Treatment of seasonal and perennial allergic rhinitis (nasal formulation).

Contraindications

Clinical warnings

• Major warning · Risk of systemic effects with high doses and/or prolonged treatment (Cushing's syndrome, adrenal suppression). Use the lowest effective dose. — EMA SPC
• Not indicated for the relief of acute asthma symptoms (asthma attacks), for which a fast- and short-acting bronchodilator is required. — EMA SPC
• An increased incidence of pneumonia has been reported in patients with COPD receiving inhaled corticosteroids. — EMA SPC

Drug interactions

• HighRitonavirJ05AE03

  Mechanism: Potent inhibition of CYP3A4, which dramatically increases fluticasone plasma concentrations and the risk of systemic corticosteroid effects (e.g., Cushing's syndrome).

  Recommendation: Co-administration is contraindicated or not recommended unless the potential benefit outweighs the risk.

  EMA SPC

• ModerateKetoconazoleJ02AB02

  Mechanism: Inhibition of CYP3A4, which increases systemic exposure to fluticasone.

  Recommendation: Use with caution. Consider lower fluticasone doses and monitor for systemic adverse effects.

  EMA SPC

Adverse events

Pregnancy and lactation

FDA category: C

Administration during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is excreted in breast milk, but therapeutic doses are unlikely to have an effect on the infant.