Allergic rhinitis, perennial (relief of nasal symptoms) or 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) (Ref). 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 (Ref). 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 (Ref). A meta-analysis of eight randomized trials supported significant decrease in adenoid size and improvement in otitis media with effusion in this population (Ref).
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.
(For additional information see "Mometasone (nasal): Drug information")
Note: For patients with mucous crusting, rinsing with saline nasal spray before mometasone administration can remove mucous crusting and improve nasal coating (Ref). If nasal obstruction is so severe that sprays cannot penetrate when treating rhinitis, consider concomitant use of an intranasal decongestant for up to 5 days (Ref).
Allergic rhinitis, seasonal, 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.
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.
Nonallergic rhinitis (off-label use): Intranasal: 2 sprays (100 mcg) in each nostril once daily (total daily dose: 200 mcg) (Ref).
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) (Ref).
Rhinosinusitis, chronic (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 (Ref).
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 (Ref).
Upper respiratory allergies (OTC): Intranasal: 2 sprays (100 mcg) in each nostril once daily.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Nasal spray adverse reactions reported in adolescents and adults; implant adverse reactions reported in adults.
>10%:
Infection: Viral infection (nasal spray: 14%)
Nervous system: Headache (nasal spray: 26%; implant: 4%)
Respiratory: Blood in nasal mucosa (nasal spray: ≤11%), epistaxis (nasal spray: ≤13%; implant: 2%), pharyngitis (nasal spray: 12%)
1% to 10%:
Cardiovascular: Chest pain (nasal spray: 2% to 5%)
Gastrointestinal: Diarrhea (nasal spray: 2% to 5%), dyspepsia (nasal spray: 2% to 5%), nausea (nasal spray: 2% to 5%)
Genitourinary: Dysmenorrhea (nasal spray: 5%)
Hypersensitivity: Hypersensitivity reaction (implant: 4%)
Neuromuscular & skeletal: Arthralgia (nasal spray: 2% to 5%), musculoskeletal pain (nasal spray: 5%), myalgia (nasal spray: 2% to 5%)
Ophthalmic: Conjunctivitis (nasal spray: 2% to 5%)
Otic: Otalgia (nasal spray: 2% to 5%), otitis media (implant: 2%)
Respiratory: Asthma (nasal spray and implant: 2% to 5%), bronchitis (nasal spray and implant: 2% to 5%), cough (nasal spray: 7%), flu-like symptoms (nasal spray: 2% to 5%), nasopharyngitis (implant: 1%), upper respiratory tract infection (nasal spray and implant: 6% to 8%)
Frequency not defined (all formulations):
Gastrointestinal: Oral candidiasis
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
Ophthalmic: Blurred vision
Respiratory: Nasal cavity pain, nasal mucosa irritation, nasal septum perforation
Hypersensitivity to mometasone or any component of the formulation.
OTC labeling: When used for self-medication, do not use to treat asthma, if nose injury or surgery is not fully healed, or in children <2 years of age.
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 tuberculosis (TB) disease (active TB) or infection (latent TB) 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.
• Self-medication (OTC use): Consult a health care provider before use if you have an eye infection; have or had glaucoma or cataracts; are using medicine for HIV infection (eg, ritonavir); are using a steroid for asthma, allergies, or skin rash; or are using ketoconazole. Discontinue use and consult a health care provider if symptoms do not improve after 1 week or new symptoms occur (eg, facial pain, thick nasal discharge); you have or come in contact with someone who has chickenpox, measles, or tuberculosis; a constant whistling sound occurs from the nose; allergic reaction occurs; changes in vision; or severe or frequent nosebleeds occur.
Nasonex 17 g bottles contain 120 sprays.
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 (10 mL,17 mL) [contains benzalkonium chloride, polysorbate 80]
Generic: 50 mcg/actuation (17 g, 10 mL, 17 mL)
May be product dependent
Implant (Propel Mini Nasal)
370 mcg (per each): $1,860.00
Implant (Propel Mini SDS Nasal)
370 mcg (per each): $1,860.00
Implant (Propel Nasal)
370 mcg (per each): $1,860.00
Implant (Sinuva Nasal)
1350 mcg (per each): $1,769.22
Suspension (Mometasone Furoate Nasal)
50 mcg/ACT (per gram): $15.07 - $15.70
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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)
When used short term as adjunctive therapy in acute bacterial rhinosinusitis (ABRS), intranasal steroids show modest symptomatic improvement and few adverse effects; improvement is primarily due to increased sinus drainage. Use should be considered optional in ABRS; however, intranasal corticosteroids should be routinely prescribed to ABRS patients who have a history of or concurrent allergic rhinitis (Chow, 2012).
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.
Intranasal:
Spray:
OTC: For intranasal administration only; do not spray into eyes or mouth. Shake bottle well. Prime pump (press 10 times or until fine spray appears) prior to first use, bottle has not been used in 1 week, or nozzle has just been cleaned; if mist does not appear after 10 pumps, nozzle may be clogged. Blow nose to clear nostrils. Close one nostril and insert tip of spray nozzle in the other nostril aiming slightly away from the center of the nose. While sniffing, press spray nozzle to release dose; exhale through mouth. After each use, wipe the spray tip with a clean tissue and replace cap. Clean spray nozzle weekly or when clogged; do not try to unblock clogs with a pin or sharp object. To clean, remove spray nozzle and rinse under running tap water; dry at room temperature. Clogged nozzles may be soaked in warm water prior to running under tap water.
Rx: 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.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect nasal spray from prolonged exposure to light.
OTC nasal spray: Store at 20°C to 25°C (68°F to 77°F).
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
Spray: Treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis and nasal congestion associated with seasonal allergic rhinitis (FDA approved in ages ≥2 years and adults); prevention of seasonal allergic rhinitis (FDA approved in ages ≥12 years and adults); treatment of nasal polyps (FDA approved in ages ≥18 years and adults); has also been used for management of nasal airway obstruction associated with adenoidal hypertrophy
Note: Intranasal corticosteroids have also been used as an adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis primarily in patients with history of allergic rhinitis (Chow 2012) and in pediatric patients with mild obstructive sleep apnea syndrome who cannot undergo adenotonsillectomy or who still have symptoms after surgery (Marcus 2012).
Implant: Treatment of nasal polyps in patients who have had ethmoid sinus surgery (FDA approved in ages ≥18 years and adults)
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
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]).
Mucous membranes for signs of fungal infection, growth (pediatric patients), signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes
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.
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