Mometasone
Regulatory sources consulted
- AEMPS-CIMA-FT-82795:https://cima.aemps.es/cima/dochtml/ft/82795/FT_82795.html
- AEMPS CIMA · nº registro 82795 ↗
- RxNorm rxcui 108118 ↗
Approved indications
- Treatment of the symptoms of seasonal or perennial allergic rhinitis in adults and children 3 years of age and older.
- Treatment of nasal polyps in adults 18 years of age and older.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Presence of an untreated localized infection involving the nasal mucosa.
- Recent nasal surgery or nasal trauma, until healing has occurred.
Clinical warnings
- 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 and may vary in individual patients. — AEMPS
- Major warning · It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids be monitored regularly. If growth is slowed, therapy should be reviewed. — AEMPS
Drug interactions
- ModeratePotent CYP3A4 inhibitors (e.g. Ketoconazole, Ritonavir, Cobicistat)J02AB02
Mechanism: Inhibition of CYP3A4-mediated metabolism of mometasone, increasing systemic exposure and the risk of systemic corticosteroid side effects.
Recommendation: Co-treatment is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the risk, in which case patients should be monitored.
AEMPS CIMA FT 82795
Adverse events
Common (≥1%)
epistaxis · pharyngitis · upper respiratory tract infection · headache
Rare but serious
glaucoma · increased intraocular pressure · cataracts · nasal septal perforation
Pregnancy and lactation
There are no or limited amount of data from the use in pregnant women. It should not be used during pregnancy unless the potential benefit justifies the potential risk. It is unknown whether it is excreted in human milk; a decision must be made whether to discontinue breast-feeding or to discontinue therapy.