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Elocon Indications, Dosage, Storage, Stability - Mometasone Furoate (nasal spray)

Elocon Indications, Dosage, Storage, Stability - Mometasone Furoate (nasal spray)

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Adults and Children 12 Years of Age and Older

The usual 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 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.

HOW SUPPLIED

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.

SHAKE WELL BEFORE EACH USE.

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