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).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied)
There are no dosage adjustments provided in the manufacturer's labeling; drug accumulation may increase with severity of hepatic impairment.
(For additional information see "Mometasone (nasal): Pediatric drug information")
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling. Mometasone concentrations appear to increase with the severity of hepatic impairment; use with caution.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Implant, Nasal, as furoate:
Propel: 370 mcg (1 ea)
Propel Mini SDS: 370 mcg (1 ea)
Sinuva: 1350 mcg (1 ea)
Suspension, Nasal, as furoate:
Nasonex: 50 mcg/actuation (17 g [DSC]) [contains benzalkonium chloride, polysorbate 80]
Generic: 50 mcg/actuation (17 g)
May be product dependent
Nasonex 17 g bottles contain 120 sprays.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Nasal, as furoate:
Nasonex: 50 mcg/actuation (1 ea) [contains benzalkonium chloride, polysorbate 80]
Generic: 50 mcg/actuation (1 ea, 17 g)
Nasonex 24HR Allergy (OTC formulation): FDA approved March 2022; availability anticipated later in 2022. Information pertaining to this product within the monograph is pending revision. Consult the prescribing information for additional information.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Nasonex: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf#page=11
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.
Intranasal:
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.
Spray: Shake well prior to each use. Before first use, prime by pressing pump 10 times or until a fine spray appears. Repeat priming with 2 sprays or until a fine spray appears if ≥1 week between use. Blow nose to clear nostrils before each use. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Do not spray into eyes or mouth. Discard after labeled number of doses has been used, even if bottle is not completely empty.
After removing nasal spray from container, avoid prolonged exposure of product to direct light; brief exposure to light (with normal use) is acceptable.
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.
Chronic rhinosinusitis; Rhinosinusitis, adjunctive treatment (acute); Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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
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.
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.
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.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Mometasone (Nasal). Risk C: Monitor therapy
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. Risk D: Consider therapy modification
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Nasal). Risk C: Monitor therapy
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]).
It is not known if mometasone is present in breast milk following nasal inhalation; however, systemic absorption is low (<1%).
Systemic corticosteroids are present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Intranasal mometasone is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).
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).
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.
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: Implant: ≤90 days
Absorption: Undetectable in plasma; clinical effects are due to direct local effect, rather than systemic absorption
Distribution: IV: Vd: 152 L
Protein binding: 98% to 99%
Metabolism: Hepatic; extensive via CYP3A4 to multiple metabolites
Bioavailability: Spray: <1%
Half-life elimination: IV: ~5 to 6 hours
Excretion: Bile (primary route): urine (limited)
Hepatic function impairment: Concentrations may increase with severity of hepatic impairment.
Implant (Propel Mini Nasal)
370 mcg (per each): $1,740.00
Implant (Propel Mini SDS Nasal)
370 mcg (per each): $1,740.00
Implant (Propel Nasal)
370 mcg (per each): $1,740.00
Implant (Sinuva Nasal)
1350 mcg (per each): $1,769.22
Suspension (Mometasone Furoate Nasal)
50 mcg/ACT (per gram): $15.07 - $15.70
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