NASONEX Nasal spray Ref.[10599] Active ingredients: Mometasone

2.1 Preparation and Administration

Administer NASONEX by the nasal route only.

Initial Priming

Prior to initial use of NASONEX, 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.

Repriming (as needed)

If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.

2.2 Recommended Dosage for Treatment of Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older: The recommended dosage for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age: The recommended dosage for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is mometasone furoate 100 mcg (administer as 1 spray into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 100 mcg).

2.3 Recommended Dosage for Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older: The recommended dosage for treatment of nasal congestion associated with seasonal allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age: The recommended dosage for treatment of nasal congestion associated with seasonal allergic rhinitis is mometasone furoate 100 mcg (administer as 1 spray into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 100 mcg).

2.4 Recommended Dosage for Prophylaxis of Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older: The recommended dosage for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) 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 2 sprays in each nostril once daily (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

2.5 Recommended Dosage for Treatment of Nasal Polyps

Adults 18 Years of Age and Older: The recommended dosage for the treatment of nasal polyps is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of 2 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.

There are no data available on the effects of acute or chronic overdosage with NASONEX. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.5)].

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.

SHAKE WELL BEFORE EACH USE.

Keep out of reach of children.