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Mometasone (Nasal)

Medically reviewed by Drugs.com. Last updated on Aug 17, 2020.

Pronunciation

(moe MET a sone)

Index Terms

  • Mometasone Furoate

Dosage Forms

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

Implant, Nasal, as furoate:

Sinuva: 1350 mcg (1 ea)

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
  • Sinuva

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

Chronic rhinosinusitis

Data from a randomized, double-blind, placebo-controlled, multicenter study supports the use of intranasal mometasone in the treatment of chronic rhinosinusitis [Mösges 2011].

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.

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 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].

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)

Chronic rhinosinusitis (off-label use): Intranasal: 2 sprays (100 mcg) in each nostril once or twice daily (total daily dose: 200 to 400 mcg) for 3 to 6 months (Chong 2016, Hamilos 2020, Huang 2013, Mösges 2011).

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 Infectious Diseases Society of America (IDSA) and American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines but no specific dosing recommendations are made. 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; perennial (relief of nasal symptoms) and seasonal (relief of nasal symptoms and congestion): Intranasal: Spray (50 mcg/spray):

Prevention: Children ≥12 years and Adolescents: 100 mcg (2 sprays) per nostril once daily (total daily dose: 200 mcg/day) beginning 2 to 4 weeks prior to pollen season

Treatment:

Children 2 to 11 years: 50 mcg (1 spray) per nostril once daily (total daily dose: 100 mcg/day)

Children ≥12 years and Adolescents: 100 mcg (2 sprays) per nostril once daily (total daily dose: 200 mcg/day)

Nasal airway obstruction/adenoidal hypertrophy: Limited data available: Children and Adolescents 3 to 15 years: Intranasal: Spray: Initial: 50 mcg (1 spray) per nostril once daily (total daily dose: 100 mcg/day) for 6 weeks, followed by the same dose given every 24 hours for the first 2 weeks of each month. Dosing based on two studies: The first was a randomized, placebo-controlled study (n=122; treatment arm: 67; age range; 3 to 15 years) in which patients received therapy for 6 weeks and 67.2% had a significant decrease in adenoid size compared to the control group (p<0.001) (Cengel 2006). The second was a 2-stage, placebo-controlled, randomized study (n=60, treatment arm: 30; age range: 3 to 7 years) which showed that after 40 days of daily mometasone therapy, ~77.7% of patients were considered responders and able to avoid adenoidectomy; those who responded continued therapy every 24 or 48 hours for the first 2 weeks of three subsequent months (Berlucchi 2007). Long-term analysis of children receiving the daily dose for the first 2 weeks of each month continued to show improvement after a mean followup period of 28 months and the need for surgery remained reduced (Berlucchi 2008). A meta-analysis of eight randomized trials supported significant decrease in adenoid size and improvement in otitis media with effusion in this population (Chohan 2015).

Nasal polyps, treatment: Adolescents ≥18 years: Intranasal:

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

Spray: 100 mcg (2 sprays) per nostril twice daily (total daily dose: 400 mcg/day); a lower dose of 200 mcg once daily delivered as 100 mcg (2 sprays) per nostril once daily may be effective in some patients

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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

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

Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Consider therapy modification

Adverse Reactions

>10%:

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

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

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

1% to 10%:

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

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

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

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

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

Neuromuscular & skeletal: Arthralgia (adolescents and adults, nasal spray: 2% to <5%), musculoskeletal pain (adolescents and adults, nasal spray: 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: Asthma (adolescents and adults: 2% to 5%), bronchitis (adolescents and adults: 2% to <5%), cough (adolescents and adults, nasal spray: 7%), flu-like symptoms (adolescents and adults, nasal spray: 2% to <5%), nasal mucosa irritation (children, nasal spray: 2% to <5%), nasopharyngitis (adults, sinus implant: 1%), rhinitis (adolescents and adults, nasal spray: 2% to <5%), sinus headache (adolescents and adults, nasal spray: 1%), sinusitis (adolescents and adults, nasal spray: 5%), upper respiratory tract infection (5% to 8%), wheezing (children, nasal spray: 2% to <5%)

Frequency not defined (all formulations): Respiratory: Nasal candidiasis, nasal mucosa ulcer, pharyngeal candidiasis

Postmarketing (all formulations):

Dermatologic: Burning sensation of the nose

Gastrointestinal: Dysgeusia

Hypersensitivity: Anaphylaxis, angioedema

Nervous system: Altered sense of smell, nasal cavity pain

Ophthalmic: Blurred vision

Respiratory: 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 Considerations

Maternal use of intranasal corticosteroids in usual doses are not associated with an increased risk of fetal malformations or preterm birth (ERS/TSANZ [Middleton 2020]).

Although intranasal mometasone has limited systemic absorption and use in pregnancy is likely acceptable, other agents have more pregnancy data and may be preferred for the treatment of allergic rhinitis in pregnant women (Alhussien 2018; BSACI [Scadding 2017]; ERS/TSANZ [Middleton 2020]).

Patient Education

What is this drug used for?

• It is used to treat and prevent allergy signs.

• It is used to treat nose polyps.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Nosebleed

• Common cold symptoms

• Cough

• Muscle pain

• Nasal irritation

• Throat irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Nasal sores

• Wheezing

• Thrush

• Painful periods

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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