NASONEX Nasal Spray, 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. NASONEX Nasal Spray, 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylaxis with NASONEX Nasal Spray, 50 mcg is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. Safety and effectiveness of NASONEX Nasal Spray, 50 mcg in pediatric patients less than 2 years of age have not been established.

NASONEX Nasal Spray, 50 mcg, is indicated for the treatment of nasal polyps in patients 18 years of age and older. Safety and effectiveness of NASONEX Nasal Spray, 50 mcg, for the treatment of nasal polyps in pediatric patients less than 18 years of age have not been established.

Allergic Rhinitis: Adults and Children 12 Years of Age and Older: The recommended dose for prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and treatment of the 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 200 mcg).

In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with NASONEX 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 the nasal symptoms of seasonal allergic 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).

Improvement in nasal symptoms of allergic rhinitis has been shown to occur within 11 hours after the first dose based on one single-dose, parallel-group study of patients in an outdoor “park” setting (park study) and one environmental exposure unit (EEU) study and within 2 days after the first dose in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks. Patients should use NASONEX Nasal Spray, 50 mcg only once daily for allergic rhinitis at a regular interval.

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.

Prior to initial use of NASONEX Nasal Spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.

Directions for Use: Illustrated Patient's Instructions for Use accompany each package of NASONEX Nasal Spray, 50 mcg.

Directions for Cleaning: Illustrated Applicator Cleaning Instructions accompany each package of NASONEX Nasal Spray, 50 mcg.

NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate per actuation. Supplied with Patient's Instructions for Use (NDC 0085-1197-01).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

When NASONEX Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.

Schering Corporation., Kenilworth, NJ 07033 USA. FDA revision date: 12/15/2004

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