Indicated for:

Treatment of Allergic Rhinitis:

• The treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis:

• The relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Prophylaxis of Seasonal Allergic Rhinitis:

• The prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.

Treatment of Nasal Polyps:

• The treatment of nasal polyps in patients 18 years of age and older.

Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids. As with any long-term topical treatment of the nasal cavity, patients using NASONEX Nasal Spray 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa.

In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with NASONEX Nasal Spray than those who received placebo.

In clinical studies with NASONEX Nasal Spray 50 mcg, the development of localized infections of the nose and pharynx with Candida albicans has occurred.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.

Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASONEX Nasal Spray.

Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of NASONEX Nasal Spray 50 mcg with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin.

Nasal Spray 50 mcg, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy.

It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when NASONEX Nasal Spray, 50 mcg is administered to nursing women.

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• Use for allergic rhinitis in patients under the age of 2. GoToSource 

• Prophylaxis of seasonal allergic rhinitis in patients under the age of 12. GoToSource 

• Use for nasal polyps in patients under the age of 18. GoToSource 

• Obstructive sleep apnea. GoToSource

• Persistent asthma. GoToSource

• Vulvar lichen sclerosus. GoToSource 

• Adenoid hypertrophy. GoToSource

Epistaxis (nosebleeds). GoToSource

Growth inhibition, hypothalamus-pituitary-adrenal axis suppression, decreased bone mineral density, myopathy (disorder of the skeletal muscles), cataracts, glaucoma, hypertension (high blood pressure), hyperglycemia (high blood sugar), thin or easily bruised skin and septal perforation (a hole in the nasal septum). GoToSource

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