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Mometasone (Nasal)

Medically reviewed on August 12, 2018

Pronunciation

(moe MET a sone)

Index Terms

  • Mometasone Furoate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Nasal, as furoate:

Nasonex: 50 mcg/actuation (17 g) [contains benzalkonium chloride, polysorbate 80]

Generic: 50 mcg/actuation (17 g)

Brand Names: U.S.

  • Nasonex

Pharmacologic Category

  • Corticosteroid, Nasal

Pharmacology

May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins). Leukocytes and macrophages may have to be present for the initiation of responses mediated by the above substances. Inhibits the margination and subsequent cell migration to the area of injury, and also reverses the dilatation and increased vessel permeability in the area resulting in decreased access of cells to the sites of injury.

Absorption

Undetectable in plasma; clinical effects are due to direct local effect, rather than systemic absorption

Distribution

IV: Vd: 152 L

Metabolism

Hepatic; extensive via CYP3A4 to multiple metabolites

Excretion

Bile (primary route); urine (limited)

Onset of Action

Spray: Improvement in allergic rhinitis symptoms may be seen within 11 hours; Maximum effect: Within 1 to 2 weeks after starting therapy

Duration of Action

Implant: ≤90 days

Half-Life Elimination

IV: ~5 to 6 hours

Protein Binding

98% to 99%

Special Populations: Hepatic Function Impairment

Concentrations may increase with severity of hepatic impairment

Use: Labeled Indications

Allergic rhinitis (seasonal and perennial) (spray only): Treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients ≥2 years.

Nasal congestion associated with seasonal rhinitis (spray only): Relief of nasal congestion associated with seasonal allergic rhinitis in adults and pediatric patients ≥2 years.

Nasal polyps: Treatment of nasal polyps in patients ≥18 years. Note: Implant is for patients who have had ethmoid sinus surgery.

Seasonal allergic rhinitis (prophylaxis) (spray only): Prophylaxis of nasal symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥12 years.

Off Label Uses

Rhinosinusitis, adjunctive treatment (acute)

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, mometasone (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS primarily when a history of allergic rhinitis exists (according to IDSA guidelines).

Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated)

Data from a randomized, double-blind, double-dummy, placebo-controlled study supports the use of intranasal mometasone in the treatment of acute, uncomplicated rhinosinusitis. Intranasal mometasone was more effective than placebo or amoxicillin in reducing major symptom scores. Symptomatic improvement occurred as early as day 2 of mometasone treatment [Meltzer 2005]. Additional trials may be necessary to further define the role of intranasal mometasone in this condition.

Chronic rhinosinusitis

Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, mometasone (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis.

Contraindications

Hypersensitivity to mometasone or any component of the formulation.

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, the possibility of cross-sensitivity cannot be ruled out with certainty because of similarities in chemical structure and/or pharmacologic actions.

Dosing: Adult

Allergic rhinitis (seasonal and perennial): Intranasal: 2 sprays (100 mcg) in each nostril once daily (total daily dose: 200 mcg)

Nasal congestion associated with seasonal rhinitis: Intranasal: 2 sprays (100 mcg) in each nostril once daily (total daily dose: 200 mcg)

Nasal polyps:

Intranasal: 2 sprays (100 mcg) in each nostril twice daily (total daily dose: 400 mcg); 2 sprays (100 mcg) in each nostril once daily may be effective in some patients

Implant: 1 implant (1,350 mcg) placed in the ethmoid sinus under endoscopic visualization for up to 90 days

Seasonal allergic rhinitis (prophylaxis): Intranasal: 2 sprays (100 mcg) in each nostril once daily (total daily dose: 200 mcg); treatment should begin 2 to 4 weeks prior to the anticipated start of pollen season

Rhinosinusitis, adjunctive treatment (acute) (off-label use): Intranasal: Intranasal corticosteroids such as mometasone are recommended by IDSA and AAO-HNS guidelines but no specific dosing recommendations are made. Alternatively, the following dosing recommendations have been made: 2 sprays (100 mcg) in each nostril twice daily (total daily dose: 400 mcg); if inadequate symptom control, may increase to 4 sprays (200 mcg) in each nostril twice daily (total daily dose: 800 mcg) (Nasonex Canadian product labeling).

Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated) (off-label use): Intranasal: 2 sprays (100 mcg) in each nostril twice daily (total daily dose: 400 mcg); up to 15 days of treatment was studied (Meltzer 2005)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Allergic rhinitis (seasonal and perennial): Intranasal:

Children 2 to 11 years: 1 spray (50 mcg) in each nostril once daily (total daily dose: 100 mcg)

Children ≥12 years and Adolescents: Refer to adult dosing.

Nasal congestion associated with seasonal rhinitis: Intranasal:

Children 2 to 11 years: 1 spray (50 mcg) in each nostril once daily (total daily dose: 100 mcg)

Children ≥12 years and Adolescents: Refer to adult dosing

Rhinosinusitis, adjunctive treatment (acute) (off-label use): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.

Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated) (off-label use): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.

Seasonal allergic rhinitis (prophylaxis): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied)

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may increase with severity of hepatic impairment.

Administration

Intranasal:

Spray: For intranasal administration only. Prime pump (press 10 times or until fine spray appears) prior to first use. If 7 or more days have elapsed since last use, reprime pump with 2 sprays or until a fine mist appears. Shake before using. Blow nose to clear nostrils. Insert applicator into nostril, tilt head slightly forward keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray; exhale through mouth. After each use, wipe the spray tip with a clean tissue and replace cap. Avoid spraying directly into nasal septum, eyes or mouth. Discard after 120 medicated sprays have been used, even if bottle is not completely empty.

Implant: Place in the ethmoid sinus under endoscopic visualization; avoid bending, twisting, or damaging implant; do not compress or load implant into the delivery system more than 2 times. Refer to manufacturer's product labeling for complete preparation, administration, and removal information.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect nasal spray from light.

Drug Interactions

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Desmopressin: Corticosteroids (Nasal) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (adolescents and adults, nasal spray: 26%; adults, sinus implant: 4%)

Infection: Viral infection (adolescents and adults, nasal spray: 14%)

Respiratory: Epistaxis (adolescents and adults, nasal spray: ≤13%; adults, sinus implant: 2%), pharyngitis (adolescents and adults, nasal spray: 12%), chronic sinusitis (adults, sinus implant: 11%), blood in nasal mucosa (adolescents and adults, nasal spray: ≤11%)

1% to 10%:

Cardiovascular: Chest pain (adolescents and adults, nasal spray: ≥2% to <5%)

Dermatologic: Skin changes (trauma; children, nasal spray: ≥2% to <5%)

Gastrointestinal: Vomiting (children, nasal spray: 5%), diarrhea (nasal spray: ≥2% to <5%), dyspepsia (adolescents and adults, nasal spray: ≥2% to <5%), nausea (adolescents and adults, nasal spray: ≥2% to <5%)

Genitourinary: Dysmenorrhea (adolescents and adults, nasal spray: 5%)

Hypersensitivity: Hypersensitivity reaction (adults, sinus implant: 4%)

Neuromuscular & skeletal: Musculoskeletal pain (adolescents and adults, nasal spray: 5%), arthralgia (adolescents and adults, nasal spray: ≥2% to <5%), myalgia (adolescents and adults, nasal spray: ≥2% to <5%)

Ophthalmic: Conjunctivitis (adolescents and adults, nasal spray: ≥2% to <5%)

Otic: Otalgia (adolescents and adults, nasal spray: ≥2% to <5%), otitis media (≥2% to <5%)

Respiratory: Upper respiratory tract infection (5% to 8%), cough (adolescents and adults, nasal spray: 7%), sinusitis (adolescents and adults, nasal spray: 5%), asthma (adolescents and adults: ≥2% to <5%), bronchitis (adolescents and adults: ≥2% to <5%), flu-like symptoms (adolescents and adults, nasal spray: ≥2% to <5%), nasal mucosa irritation (children, nasal spray: ≥2% to <5%), rhinitis (adolescents and adults, nasal spray: ≥2% to <5%), wheezing (children, nasal spray: ≥2% to <5%), nasopharyngitis (adults, sinus implant: 1%), sinus headache (adolescents and adults, nasal spray: 1%)

Frequency not defined: Respiratory: Nasal candidiasis, nasal mucosa ulcer, pharyngeal candidiasis

<1%, postmarketing, and/or case reports: Altered sense of smell, anaphylaxis, angioedema, blurred vision, burning sensation of the nose, dysgeusia, nasal septum perforation

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: When recommended doses are exceeded, or in extremely sensitive individuals, may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. Reports consistent with hypercortisolism are rare. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.

• Hypersensitivity reactions: Hypersensitivity reactions, including rash, pruritus, angioedema, and wheezing, have been reported; discontinue if such reactions occur.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid exposure to chickenpox and/or measles, especially if not immunized.

• Local nasal effects: Nasal septum perforation, epistaxis, irritation, and infection of the nose and/or pharynx may occur. Periodically examine nasal mucosa; discontinuation of therapy may be necessary if an infection occurs. Avoid use of nasal implant in patients with nasal ulcers or trauma.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment: drug accumulation may increase with severity of hepatic impairment.

• Infections: Use with caution or avoid use in patients with active or latent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Do not use in untreated localized infection involving the nasal mucosa; concurrent antimicrobial therapy should be administered if bacterial infection of the sinuses is suspected/confirmed.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users or in patients who report visual changes.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).

Other warnings/precautions:

• Appropriate use: Implant: For patients who have had ethmoid sinus surgery; insertion by health care providers trained in otolaryngology only. There are no studies evaluating repeat implantation of the implant.

• Appropriate use: Spray: Prior to use, the dose and duration of treatment should be based on the risk vs benefit for each individual patient. In general, use the smallest effective dose for the shortest duration of time to minimize adverse events. A gradual tapering of dose may be required prior to discontinuing therapy. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing inhalation therapy.

Monitoring Parameters

Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; glaucoma and/or cataracts, especially in patients with a change in vision; adverse nasal effects (eg, nasal septal perforation, nasal ulceration, irritation, epistaxis, infection).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies.

Intranasal corticosteroids, including mometasone, may be acceptable for the treatment of rhinitis during pregnancy when used at recommended doses (Lal 2016; Wallace 2008). Pregnant women adequately controlled on mometasone may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant women may be preferred (Namazy 2016; Wallace 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, cough, muscle pain, sinus pain, or pharyngitis. Have patient report immediately to prescriber signs of infection, signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), severe rhinitis, severe nosebleed, nasal sores, wheezing, thrush, painful periods, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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