NASONEX

NASONEX- mometasone furoate monohydrate spray, metered
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

1.1 Treatment of Allergic Rhinitis

NASONEX® 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.

1.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

NASONEX is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.

1.3 Prophylaxis of Seasonal Allergic Rhinitis

NASONEX is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.

1.4 Treatment of Nasal Polyps

NASONEX is indicated for the treatment of nasal polyps in patients 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

Nasal spray: 50 mcg, metered-dose, manual pump spray.

After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 50 mcg of mometasone furoate.

4 CONTRAINDICATIONS

NASONEX is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

Epistaxis
In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with NASONEX than those who received placebo [see Adverse Reactions (6)].

Candida Infection
In clinical studies with NASONEX, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of NASONEX should be discontinued and appropriate local or systemic therapy instituted, if needed.

Nasal Septum Perforation
Instances of nasal septum perforation have been reported following the nasal application of corticosteroids. As with any long-term topical treatment of the nasal cavity, patients using NASONEX over several months or longer should be examined periodically for possible changes in the nasal mucosa.

Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

5.2 Glaucoma and Cataracts

Glaucoma and cataracts may be reported with systemic and topical (including nasal, inhaled and ophthalmic) corticosteroid use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use NASONEX long term [see Adverse Reactions (6)].

5.3 Hypersensitivity Reactions

Hypersensitivity reactions including instances of wheezing may occur after the nasal administration of mometasone furoate monohydrate. Discontinue NASONEX if such reactions occur [see Contraindications (4)].

5.4 Immunosuppression and Risk of Infections

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective Prescribing Information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.

5.5 Hypercorticism and Adrenal Suppression

When nasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of NASONEX should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

5.6 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASONEX. To minimize the systemic effects of nasal corticosteroids, including NASONEX, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

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