Metomark Nasal Spray

Each Metered Spray Delivers:

Mometasone Furoate Monohydrate

Equivalent to Mometasone Furoate USP   50 mcg

Composition:

Mometasone Furoate Monohydrate

Equivalent to Mometasone Furoate USP    0.05% w/v

Preservative

Benzalkonium Chloride Solution BP  0.02% w/v

Phenyl Ethyl Alcohol USP    0.25% w/v

Uses

Mometasone Furoate Nasal Spray is indicated for use in adults and children 12 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.

Mometasone Furoate Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.

Mometasone Furoate Nasal Spray is also indicated or use in children 6 to 11 years of age to treat the symptoms of seasonal allergic or perennial allergic rhinitis.

In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Mometasone Furoate Nasal Spray may be initiated up to four weeks prior to the anticipated start of the pollen season.

Side Effect

Treatment-related adverse events reported in clinical studies for allergic rhinitis in adult and adolescent patients are shown below (Table 1).

Epistaxis was generally self-limiting and mild in severity and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.

In the pediatric population, the incidence of adverse events, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.

In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.

 Treatment-related adverse events reported in ≥1% of patients in clinical studies for polyposis are shown below (Table 2)

In patients treated for acute rhinosinusitis, the incidence of epistaxis for Mometasone Furoate was 3.3% vs. 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.

Rarely. immediate hypersensitivity reactions, including bronchospasm and dyspnea may occur after intranasal administration of Mometasone Furoate Monohydrate. Very rarely, anaphylaxis and angioedema have been reported.

Disturbances of taste and smell have been reported very rarely.

As with other intranasal corticosteroids rare cases of nasal septum perforation have been reported.

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

Rare cases of glaucoma, increased intraocular pressure and/or cataracts have been reported with the use of intranasal corticosteroids