Mometasone Furoate nasal spray is indicated for the treatment of nasal symptoms of allergic rhinitis in patients 2 years of age and older. It is indicated for the treatment of nasal congestion associated with seasonal allergic rhinitis in patients 2 years of age and older. It is indicated for the prophylaxis of seasonal allergic rhinitis in patients 12 years of age and older. It is also indicated for the treatment of nasal polyps in patients 18 years of age and older.

Mometasone Furoate is a corticosteroid with anti-inflammatory activity. The exact mechanism of corticosteroid action in allergic rhinitis is not fully understood. Corticosteroids have been shown to exert a wide range of effects on multiple cell types such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes, as well as mediators including histamine, eicosanoids, leukotrienes, and cytokines involved in inflammation.

Allergic Rhinitis

• Adults and Children 12 Years of Age and Older: The recommended dose for prophylaxis and treatment of nasal symptoms of seasonal allergic rhinitis and treatment of nasal symptoms of perennial allergic rhinitis is two sprays (50 mcg of Mometasone Furoate in each spray) in each nostril once daily (total daily dose of 100 mcg). In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with Mometasone Nasal Spray 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.
• Children 2 to 11 Years of Age: The recommended dose for treatment of nasal symptoms of seasonal and perennial allergic rhinitis is one spray (50 mcg of Mometasone Furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

Nasal Polyps

• Adults 18 years of Age and Older: The recommended dose for nasal polyps is two sprays (50 mcg of Mometasone Furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of two sprays (50 mcg of Mometasone Furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.

How to use the Nasal Spray:

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine mist comes out.
• Gently blow the nose to clear the nostrils.
• Close one nostril and insert the nasal applicator into the open nostril. Tilt your head slightly forward and keep the spray upright. Breathe in through your nose and while breathing in, press the white collar of the nasal applicator firmly once to release a spray.
• Breathe out through your mouth.
• Repeat the same steps for the other nostril if required.

Cleaning:

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off excess water and allow to dry naturally. Do not apply heat.
• Reattach the applicator and dust cover after drying.

No clinically significant drug interactions have been reported with Mometasone Furoate.

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

Side effects are generally mild and may include headache, viral infection, pharyngitis, epistaxis, and cough.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Mometasone Furoate, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. It is not known whether Mometasone Furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be taken when Mometasone Furoate Nasal Spray is administered to nursing women.

Caution is required in patients with active or latent tuberculosis, untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex. Patients should be monitored periodically for signs of nasal mucosal adverse effects. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Patients with vision changes or a history of increased intraocular pressure, glaucoma, or cataracts should be closely monitored.

Pediatric use: Safety and effectiveness in children below 2 years of age have not been established.

Nasal Steroid Preparations

Store at or below 30°C. Protect from light and moisture. Keep out of reach of children.