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APOTEX CORP
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60505083001

mometasone furoate 50 mcg spry (generic nasonex)

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Uses

Allergic Rhinitis

Mometasone furoate nasal spray is used for the prophylaxis and treatment of nasal symptoms of seasonal allergic rhinitis and for the treatment of nasal symptoms of perennial allergic rhinitis.

In patients with seasonal or perennial allergic rhinitis, intranasal administration of mometasone furoate is more effective than placebo and appears to be as effective as other intranasal corticosteroids (e.g., beclomethasone dipropionate, fluticasone propionate) in relieving moderate to severe nasal symptoms, including stuffiness, rhinorrhea, itching, and sneezing. In patients with seasonal or perennial rhinitis, maximum benefit usually occurs within 1-2 weeks of continuous intranasal mometasone furoate therapy, although symptomatic relief may be evident within as little as 5-11 hours after the initial dose.

Prophylactic administration of mometasone furoate nasal spray beginning 2-4 weeks prior to the onset of the pollen season in patients with seasonal allergic rhinitis resulted in a smaller increase in nasal symptoms than with placebo.

Nasal Polyposis

Mometasone furoate nasal spray is used in the management of nasal polyposis. In 2 placebo-controlled trials evaluating intranasal mometasone furoate therapy (200 mcg once or twice daily for 4 months) in patients with existing bilateral nasal polyps, reductions in the size of polyps and the degree of nasal congestion were observed with mometasone furoate at a dosage of 200 mcg twice daily. At a dosage of 200 mcg once daily, an effect of mometasone furoate on reduction in the size of nasal polyps was not consistently demonstrated.

Dosage and Administration

General

Mometasone furoate aqueous suspension is administered by nasal inhalation using a special nasal inhaler. Prior to initial use of the inhaler, the pump should be primed by actuating 10 times or until a fine spray appears. If the pump is unused for more than 1 week, the pump should again be primed by actuating twice or until a fine spray appears.

Dosage of mometasone furoate, which is commercially available as the monohydrate, is calculated on the anhydrous basis. Each spray from the inhaler delivers 50 mcg of mometasone furoate.

Allergic Rhinitis

For treatment of the nasal symptoms of seasonal or perennial allergic rhinitis, the usual recommended dosage of mometasone furoate in adults and children 12 years of age or older is 100 mcg (2 sprays) in each nostril daily (total daily dosage of 200 mcg). While mometasone furoate dosages of 50-800 mcg daily were studied in controlled trials in adults and children 12 years of age and older, most of these patients received 200 mcg daily. For the symptomatic treatment of seasonal or perennial allergic rhinitis in children 2-11 years of age, the usual recommended dosage of mometasone furoate is 50 mcg (1 spray) in each nostril daily (total daily dosage of 100 mcg). In young children, administration of mometasone furoate nasal spray should be aided by an adult.

For prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adults and children 12 years of age or older with a known seasonal allergen, the recommended dosage of mometasone furoate is 200 mcg daily (2 sprays in each nostril daily) beginning 2-4 weeks prior to the anticipated start of the pollen season.

Nasal Polyposis

For the treatment of nasal polyposis, the usual dosage of mometasone furoate in patients 18 years of age or older is 100 mcg (2 sprays) in each nostril twice daily (total daily dosage of 400 mcg). A mometasone furoate dosage of 100 mcg (2 sprays) in each nostril once daily (total daily dosage of 200 mcg) may be effective in some patients.

Special Populations

No special population recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to mometasone furoate or any ingredient in the formulation.

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

In patients being switched from systemic corticosteroids to topical corticosteroids, systemic corticosteroid therapy should be withdrawn gradually since adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, depression) could occur. Particular caution is necessary in patients who have associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.

Hypercorticism

Manifestations of hypercorticism, including very rare cases of menstrual irregularities, acneiform lesions, and cushingoid features, may occur in patients who are particularly sensitive or predisposed to corticosteroid effects because of recent systemic corticosteroid therapy or when recommended dosages of intranasal corticosteroids, including mometasone furoate, are exceeded. (See General Precautions: Systemic Corticosteroid Effects, in Cautions.)

Infection

Patients who become immunosuppressed while receiving corticosteroids have increased susceptibility to infections compared with healthy individuals, and certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients. For additional information, and also .

Sensitivity Reactions

Rarely, immediate hypersensitivity reactions may occur following intranasal administration of mometasone. Wheezing has been reported very rarely.

General Precautions

Systemic Corticosteroid Effects

Intranasal corticosteroids such as mometasone furoate may cause growth suppression in children or adolescents, and clinicians should routinely monitor (e.g., via stadiometry) the growth of pediatric patients receiving these drugs. In a 1-year, placebo-controlled clinical study, no statistically significant effect on growth velocity was observed in children 3-9 years of age receiving mometasone furoate 100 mcg daily. To minimize the systemic effects of intranasal corticosteroids, including mometasone furoate, dosage should be titrated to the lowest possible effective level. When nasal corticosteroids are used in excessive dosages, systemic corticosteroid effects such as hypercorticism or adrenal suppression can occur. If such changes are apparent, intranasal mometasone furoate should be discontinued gradually according to accepted procedures for discontinuing oral corticosteroid therapy. Adrenal suppression has not been observed to date when intranasal mometasone furoate was administered in adults at dosages of 200 or 400 mcg daily for up to 4 months, 400 or 1600 mcg daily for up to 29 days, or in children 2-5 years of age at a dosage of 100 mcg daily for up to 42 days.

Nasopharyngeal Effects

Localized candidal infections of the nose and/or pharynx have occurred rarely during intranasal mometasone therapy. Nasal burning and irritation also have been reported in patients receiving the drug. Nasal septum perforation has been reported rarely in patients receiving mometasone nasal spray. Examination of nasal biopsies in patients with perennial allergic rhinitis who received intranasal mometasone furoate 200 mcg once daily for 12 months did not show any signs of nasal mucosal atrophy. However, patients receiving the drug for several months or longer should be examined periodically for changes in the nasal mucosa. Because corticosteroid therapy may inhibit wound healing, patients with recent nasal septum ulcers, nasal surgery, or nasal trauma should not use nasal corticosteroids until healing has occurred.

Concomitant Infections

Nasal corticosteroids should be used with caution, if at all, in patients with clinical tuberculosis or asymptomatic M. tuberculosis infections of the respiratory tract; untreated fungal, bacterial, or systemic viral infections; or ocular herpes simplex infections.

Ophthalmic Effects

No ophthalmologic abnormalities (i.e., elevation in intraocular pressure, cataracts) have been observed with intranasal mometasone furoate therapy when slit-lamp or tonometric examinations were conducted in studies of up to 12 months' duration. However, glaucoma, increased intraocular pressure, and cataracts have been reported rarely in patients receiving nasal or inhaled corticosteroids, and careful monitoring is recommended in patients who have a change in vision and in those with a history of glaucoma and/or cataracts.

Specific Populations

Pregnancy

Category C. Administration of corticosteroids during pregnancy may result in hypoadrenalism in the infant.

Lactation

Not known whether mometasone furoate is distributed in milk. Caution is advised if the drug is administered in nursing women.

Pediatric Use

Safety and efficacy of intranasal mometasone furoate not established in children younger than 2 years of age for the treatment of allergic rhinitis or younger than 18 years of age for the treatment of nasal polyposis, respectively. Intranasal corticosteroids, including mometasone furoate, may cause a reduction in growth velocity in pediatric patients. (See General Precautions: Systemic Corticosteroid Effects, in Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of allergic rhinitis include headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, and upper respiratory tract infection; in addition, dysmenorrhea, musculoskeletal pain, and sinusitis (in patients 12 years of age or older) and vomiting (in patients 3-11 years of age).

Adverse effects occurring in 5% or more of patients receiving mometasone furoate for the treatment of nasal polyposis and more frequently than with placebo include epistaxis.

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