Mometasone Furoate (Nasonex)

1. Health Canada Product Monograph — Mometasone Furoate

• Used to treat symptoms of seasonal or perennial allergic rhinitis in adults and children age 3 years and older.
• Used as adjunctive treatment with antibiotics for acute bacterial rhinosinusitis, and as monotherapy for mild to moderate uncomplicated acute rhinosinusitis, in patients age 12 and older.
• Used to treat nasal polyps in adults age 18 and older.

• No adequate, well-controlled studies exist in pregnant women; as with other nasal corticosteroids, it should be used in pregnancy only if the potential benefit justifies the potential risk to the mother, fetus, or infant.
• Infants born to mothers who received corticosteroids during pregnancy should be watched carefully for signs of low adrenal function.

• No adequate, well-controlled studies exist in nursing mothers; use during breastfeeding should be based on whether the expected benefit to the mother outweighs any potential risk to the infant, given the drug's minimal systemic absorption.

• The same adult dosing is used in older adults, including for adjunctive rhinosinusitis and nasal polyp treatment; no specific age-based dose adjustment is described in the product information.

• Approved for allergic rhinitis in children 3 to 11 years old, at one spray in each nostril once daily; a year-long placebo-controlled trial found normal growth was maintained at this dose.
• Not established for adjunctive rhinosinusitis treatment, uncomplicated acute rhinosinusitis, or nasal polyps in children under 12 (or under 18 for nasal polyps), and young children should be helped with administration by an adult.

• For allergic rhinitis, adults and children 12 and older typically use two sprays (50 mcg each) in each nostril once daily (200 mcg total); children 3 to 11 years use one spray in each nostril once daily (100 mcg total).
• For adjunctive rhinosinusitis or uncomplicated acute rhinosinusitis in patients 12 and older, the usual dose is two sprays in each nostril twice daily, which may be increased to four sprays in each nostril twice daily if symptoms are not adequately controlled; for nasal polyps, the usual dose is two sprays in each nostril twice daily, which may be reduced to two sprays in each nostril once daily once symptoms are controlled.
• The spray pump should be primed with 10 actuations before first use (or 2 actuations if unused for 14 days or more) and the bottle shaken well before each use; noticeable relief may take up to 12 hours or longer, so the spray should be used at regular intervals rather than as-needed.

• Headache may occur.
• Nosebleed (epistaxis) may occur, generally mild and self-limiting.
• Sore throat (pharyngitis) may occur.
• Nasal burning or irritation may occur.
• Sneezing may occur, particularly in children.
• Dry mouth may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Rarely, an immediate hypersensitivity reaction such as bronchospasm or difficulty breathing can occur after use.
• Very rarely, anaphylaxis or angioedema (swelling of the face, mouth, or throat) can occur.
• Nasal septum perforation has been reported very rarely with long-term use of nasal corticosteroid sprays.
• Localized fungal infection of the nose or throat can develop with prolonged use.
• Increased eye pressure, and rarely glaucoma, cataracts, or vision changes such as blurred vision, have been reported with long-term corticosteroid use, including nasal formulations.
• If transferred from an oral or systemic corticosteroid to this nasal spray, symptoms of systemic corticosteroid withdrawal (joint or muscle pain, tiredness, low mood) can occur, and previously suppressed allergic conditions such as eczema may reappear.
• Recent nasal surgery or trauma can be slower to heal if a nasal corticosteroid is used before the area has fully healed.

• Use with caution in patients with active or dormant tuberculosis of the respiratory tract, or with untreated fungal, bacterial, or systemic viral infection, or ocular herpes simplex.
• Use with caution in patients recently transferred from long-term systemic corticosteroid therapy, since they may be at risk of adrenal insufficiency during the transition.
• Use with caution in patients with recent nasal ulceration, nasal surgery, or trauma until healing has occurred.
• Patients who are immunosuppressed by corticosteroid use should be cautioned about exposure to chickenpox or measles and advised to seek medical advice promptly if exposed.
• Patients should be examined periodically if the spray is used for several months or longer, to check for any changes in the nasal lining.

• Known hypersensitivity to mometasone furoate or to any ingredient in the formulation or component of the container.
• Should not be used in the presence of untreated localized infection involving the nasal mucosa.
• Should not be used in place of an antibiotic if bacterial sinus infection is present or suspected, since the spray alone is not appropriate treatment for that infection.

• Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, and certain HIV medications (atazanavir, indinavir, nelfinavir, saquinavir, ritonavir, cobicistat-containing products) may increase systemic corticosteroid exposure and side-effect risk; this combination should generally be avoided unless the benefit outweighs the risk, with monitoring for systemic corticosteroid effects if used together.
• No clinically significant interaction has been found with loratadine, an antihistamine commonly used alongside nasal corticosteroids for allergic rhinitis.

• No specific food interactions have been identified, consistent with the drug's minimal systemic absorption when used as directed.

• Should be used at regular, scheduled intervals (for example, once or twice daily as prescribed) rather than as-needed, since the anti-inflammatory benefit builds with consistent use and is not an immediate decongestant effect.
• The nose should be blown first, then the nozzle inserted into one nostril while gently closing off the other, spraying while breathing in gently through the nose with the mouth closed.

• Store between 2 and 25 degrees C, protected from light; do not freeze.
• Keep out of the reach and sight of children.

• Nasonex (mometasone furoate) is a nasal corticosteroid spray used regularly to control symptoms of allergic rhinitis, as an add-on for sinus infections, or for nasal polyps; it works best when used consistently, not just when symptoms flare.
• Follow the prescribed dosing schedule (typically once or twice daily), and expect noticeable relief within about 12 hours, with fuller benefit over days to weeks.
• Common effects include headache, nosebleed, sore throat, and nasal irritation or dryness.
• Contact the prescriber promptly for worsening or severe sinus symptoms such as fever, facial swelling, or one-sided facial pain, and seek immediate medical attention for signs of a severe allergic reaction such as facial or throat swelling or difficulty breathing.
• Blow the nose before each use, aim the spray away from the nasal septum (the wall between the nostrils), shake the bottle well, and prime the pump before first use or if it has not been used for 14 days or more.
• Store the bottle between 2 and 25 degrees C, away from light and out of children's reach, and avoid freezing.