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Nasonex

Nasonex

INDICATIONS

Treatment of Allergic Rhinitis

NASONEX® (mometasone furoate (nasal spray)) 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.

Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for 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

NASONEX (mometasone furoate (nasal spray)) 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.

Treatment of Nasal Polyps

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION

Administer NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of NASONEX (mometasone furoate (nasal spray)) 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.

Treatment of Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 2 sprays (50 mcg of mometasone furcate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray (50 mcg of mometasone furcate in each spray) in each nostril once daily (total daily dose of 100 mcg).

Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

Prophylaxis of Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is 2 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 (mometasone furoate (nasal spray)) Nasal Spray 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

Treatment of Nasal Polyps

Adults 18 Years of Age and Older

The recommended dose 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.

HOW SUPPLIED

Dosage Forms and Strengths

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis.

After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mg or 100 microliter of suspension containing mometasone furoate monohydrate equivalent to 50 mcg of mometasone furoate calculated on the anhydrous basis. Each bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg provides 120 sprays.

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.

(NDC 0085-1288-01).

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

When NASONEX (mometasone furoate (nasal spray)) 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.

Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: January 2011

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.

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