Introduction

Synthetic nonfluorinated corticosteroid.

Uses for Mometasone (EENT)

Allergic Rhinitis

Prophylaxis and treatment of nasal symptoms of seasonal allergic rhinitis.

Treatment of nasal symptoms of perennial allergic rhinitis.

Mometasone (EENT) Dosage and Administration

General

• For therapeutic effectiveness, use at regular intervals.

Administration

Intranasal Administration

Administer by nasal inhalation using a a metered-dose nasal spray pump.

Shake inhaler gently immediately prior to use.

Prior to initial use, the metered-dose pump spray must be primed with 10 actuations or until a fine spray appears. Prime pump after a period of nonuse (i.e., >1 week) by actuating twice or until a fine spray appears.

Clear nasal passages prior to administration.

Tilt the head slightly forward, insert the nasal applicator into one nostril, and point the tip of the applicator away from the nasal septum. Pump the drug into the nostril while holding the other nostril closed and concurrently inspiring through the nose. Repeat procedure for the other nostril.

Clean nasal applicator by removing the nasal applicator and plastic cap. Soak the nasal applicator in cold tap water and/or rinse in warm water and dry. Rinse the plastic cap under cold water and dry. Reassemble the nasal applicator with the pump by reinserting the pump stem into the center opening of the applicator. Reprime the pump by actuating twice or until a fine spray appears.

Dosage

Available as mometasone furoate monohydrate; dosage expressed in terms of anhydrous mometasone furoate.

After priming, nasal spray pump delivers about 50 mcg of mometasone furoate per metered spray and about 120 metered doses per 17-g container.

Pediatric Patients

Titrate dosage to the lowest possible effective level. (See Pediatric Use under Cautions.)

Allergic Rhinitis

Treatment of Seasonal or Perennial Allergic Rhinitis

Children 2–11 years of age: 50 mcg (1 spray) in each nostril once daily (100 mcg total daily dosage).

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).

Prophylaxis of Seasonal Allergic Rhinitis

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.

Adults

Allergic Rhinitis

Treatment of Seasonal or Perennial Allergic Rhinitis

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).

Prophylaxis of Seasonal Allergic Rhinitis

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.

Contraindications

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

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.

Hypercorticism

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects due to recent systemic corticosteroid therapy may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cushingoid features). (See Systemic Corticosteroid Effects under Cautions.)

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs. Certain infections (e.g., varicella [chickenpox], measles) can be serious or even fatal in such patients, particularly in children.

Exposure to varicella and measles should be avoided in previously unexposed patients. If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG), respectively. Consider treatment with an antiviral agent if varicella develops.

Sensitivity Reactions

Rarely, immediate hypersensitivity reactions or wheezing may occur.

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in children or adolescents. (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercorticism, adrenal suppression).

Avoid use of higher than recommended dosages. If systemic effects occur, slowly reduce dosage and discontinue drug.

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx have been reported. Local treatment of such infections and/or discontinuance of intranasal therapy may be required.

Possible nasal burning and irritation. Rarely, nasal septum perforation has been reported.

Periodically examine nasal passages for signs of mucosal changes during long-term therapy (several months or longer).

Use not recommended in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.

Concomitant Infections

Use with caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infection 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) observed in long-term studies with mometasone furoate. Glaucoma, increased intraocular pressure, and cataracts have been reported rarely with other nasal or inhaled corticosteroids.

Monitor patients who have a change in vision and those with a history of glaucoma or cataracts.

Specific Populations

Pregnancy

Category C.

Use during pregnancy may result in hypoadrenalism in infants; monitor these infants carefully.

Lactation

Not known whether mometasone furoate is distributed into milk; caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children <2 years of age.

Intranasal corticosteroids may reduce growth velocity in pediatric patients. Routine monitoring of growth (e.g., via stadiometry) recommended. Titrate dosage to the lowest possible effective level.

Geriatric Use

Adverse effects profiles similar to those in younger adults.

Common Adverse Effects

Headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, upper respiratory tract infection, dysmenorrhea, musculoskeletal pain, sinusitis, vomiting.

General

• For therapeutic effectiveness, use at regular intervals.

Administration

Intranasal Administration

Administer by nasal inhalation using a a metered-dose nasal spray pump.

Shake inhaler gently immediately prior to use.

Prior to initial use, the metered-dose pump spray must be primed with 10 actuations or until a fine spray appears. Prime pump after a period of nonuse (i.e., >1 week) by actuating twice or until a fine spray appears.

Clear nasal passages prior to administration.

Tilt the head slightly forward, insert the nasal applicator into one nostril, and point the tip of the applicator away from the nasal septum. Pump the drug into the nostril while holding the other nostril closed and concurrently inspiring through the nose. Repeat procedure for the other nostril.

Clean nasal applicator by removing the nasal applicator and plastic cap. Soak the nasal applicator in cold tap water and/or rinse in warm water and dry. Rinse the plastic cap under cold water and dry. Reassemble the nasal applicator with the pump by reinserting the pump stem into the center opening of the applicator. Reprime the pump by actuating twice or until a fine spray appears.

Dosage

Available as mometasone furoate monohydrate; dosage expressed in terms of anhydrous mometasone furoate.

After priming, nasal spray pump delivers about 50 mcg of mometasone furoate per metered spray and about 120 metered doses per 17-g container.

Pediatric Patients

Titrate dosage to the lowest possible effective level. (See Pediatric Use under Cautions.)

Allergic Rhinitis

Treatment of Seasonal or Perennial Allergic Rhinitis

Children 2–11 years of age: 50 mcg (1 spray) in each nostril once daily (100 mcg total daily dosage).

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).

Prophylaxis of Seasonal Allergic Rhinitis

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.

Adults

Allergic Rhinitis

Treatment of Seasonal or Perennial Allergic Rhinitis

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).

Prophylaxis of Seasonal Allergic Rhinitis

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.