Nasonex

Nasonex Information

Brand Name: Nasonex

Other Common Names: Rinelon

Nasonex Nasal Spray, 50 µg is indicated for the prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and the treatment of the nasal symptoms of perennial allergic rhinitis, in adults and children 12 years of age 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 µg is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

Nasonex Ingredients and Composition

How Does Nasonex Work?

Nasonex Nasal Spray, 50 µg is a corticosteroid demonstrating anti- inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

Mometasone furoate demonstrated no mineralocorticoid, androgenic, antiandrogenic, or estrogenic activity in preclinical studies. After administration of a single intranasal dose of mometasone furoate to adult male rats, the highest drug levels were seen in the esophagus, trachea, nasal passage, and mouth.

In two clinical Nasonex studies utilizing nasal antigen challenge, Nasonex Nasal Spray, 50 µg decreased some markers of the early- and late- phase allergic response. These observations included decreases (vs placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known.

The effect of Nasonex Nasal Spray, 50 µg on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (eg, eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells).

How To Take Nasonex and Nasonex Dosage and Administration

Adults and Children 12 Years of Age and Older

The usual recommended Nasonex 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 µg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 µg).

In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with Nasonex Nasal Spray, 50 µg (200 µg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

Improvement in nasal symptoms generally occurs within 2 days after the first dose. Maximum benefit is usually achieved within 1 to 2 weeks. Patients should use Nasonex Nasal Spray, 50 µg only once daily at a regular interval.

Prior to initial use of Nasonex Nasal Spray, 50 µg, 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 µg.

Shake well before each use.

If you suspect a Nasonex Overdose

There are no data available on the effects of acute or chronic overdosage with Nasonex Nasal Spray, 50 µg. 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. Intranasal administration of 1600 µg (8 times the recommended dose of Nasonex Nasal Spray, 50 µg) daily for 29 days, to healthy human volunteers, was well tolerated with no increased incidence of adverse events. Single intranasal doses up to 4000 µg have been studied in human volunteers with no adverse effects reported. Single oral doses up to 8000 µg have been studied in human volunteers with no adverse events reported. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism. Acute overdosage with this dosage form is unlikely since one bottle of Nasonex Nasal Spray, 50 µg contains approximately 8500 µg of mometasone furoate.

Nasonex Side Effects

Nasonex Warnings

Nasonex Clinical Trials and Studies

Nasonex Pill Identification / ID and Appearance

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

Store between 2° and 25° C (36° and 77° F). Protect from light.

When Nasonex Nasal Spray, 50 µg 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.