Furoato de fluticasona
Regulatory sources consulted
- EMA EPAR EMEA/H/C/000770
- AEMPS CIMA 07434003
- AEMPS CIMA · nº registro 07434003 ↗
- EMA EPAR · EMEA/H/C/000770 ↗
- RxNorm rxcui 705022 ↗
Approved indications
- Treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6-11 years).
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Systemic effects: Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. — EMA
- Major warning · Growth retardation: Regular monitoring of height is recommended in children receiving prolonged treatment with nasal corticosteroids. — EMA
- Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, an ophthalmologist referral should be considered. — EMA
Drug interactions
- HighRitonavirJ05AE03
Mechanism: Potent inhibition of CYP3A4, significantly increasing fluticasone furoate plasma concentration and the risk of systemic corticosteroid effects.
Recommendation: Co-administration is not recommended due to the risk of increased systemic corticosteroid effects.
EMA SPC
- ModerateKetoconazoleJ02AB02
Mechanism: Inhibition of CYP3A4, which may increase systemic exposure to fluticasone furoate.
Recommendation: Use with caution. Monitor for potential systemic corticosteroid adverse effects.
EMA SPC
Adverse events
Common (≥1%)
epistaxis · headache · nasal ulceration
Rare but serious
hypersensitivity reactions (anaphylaxis, angioedema) · growth retardation (pediatric population) · glaucoma · cataracts · nasal septal perforation
Pregnancy and lactation
Pregnancy: There are no adequate data. Administer only if the expected benefit to the mother is greater than any possible risk to the fetus. Lactation: It is unknown whether it is excreted in human milk; a decision must be made whether to discontinue breast-feeding or to discontinue therapy.