(moe MET a sone)
Allergic rhinitis (seasonal and perennial): Treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients ≥2 years (US labeling) and ≥3 years (Canadian labeling).
Nasal congestion associated with seasonal rhinitis: Relief of nasal congestion associated with seasonal allergic rhinitis in adults and pediatric patients ≥2 years.
Nasal polyps: Treatment of nasal polyps in adults.
Seasonal allergic rhinitis (prophylaxis): Prophylaxis of nasal symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥12 years.
Canadian labeling: Additional use (not in US labeling): Treatment of mild-to-moderate uncomplicated rhinosinusitis or as adjunctive treatment (with antimicrobials) in acute rhinosinusitis in adults and pediatric patients ≥12 years
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.
US labeling:
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
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
Canadian labeling:
Allergic rhinitis (seasonal and perennial): Intranasal: Initial: 2 sprays (100 mcg) in each nostril once daily (total daily dose: 200 mcg); upon symptom control, may consider dose reduction to 1 spray (50 mcg) in each nostril once daily as maintenance therapy. Note: If adequate symptom control is not achieved with initial dosing, may increase dose to 4 sprays (200 mcg) in each nostril once daily (total daily dose: 400 mcg). Dose reduction is recommended upon symptom control.
Nasal polyps: Intranasal: 2 sprays (100 mcg) in each nostril twice daily (total daily dose: 400 mcg); upon symptom control, may consider dose reduction to 2 sprays (100 mcg) once daily which may be effective for continued treatment; treatment duration for 4 months has been studied
Rhinosinusitis, adjunctive treatment (acute): Intranasal: 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)
Rhinosinusitis treatment (acute, mild to moderate, uncomplicated): Intranasal: 2 sprays (100 mcg) in each nostril twice daily (total daily dose: 400 mcg); use beyond 15 days has not been studied.
Refer to adult dosing.
US labeling:
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
Seasonal allergic rhinitis (prophylaxis): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.
Canadian labeling:
Allergic rhinitis (seasonal and perennial): Intranasal:
Children 3 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): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.
Rhinosinusitis treatment (acute, mild to moderate, uncomplicated): Intranasal: Children ≥12 years and Adolescents: Refer to adult dosing.
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 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 (or 14 days for Canadian product), 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.
Store at 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Protect from light.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Nasal, as furoate:
Propel Mini: 370 mcg (1 ea)
Suspension, Nasal, as furoate:
Nasonex: 50 mcg/actuation (17 g) [contains benzalkonium chloride]
Generic: 50 mcg/actuation (17 g)
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
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, epistaxis, localized Candida albicans infections).
>10%:
Central nervous system: Headache (17% to 26%)
Respiratory: Pharyngitis (8% to 13%), cough (nasal inhalation 7% to 13%), epistaxis (1% to 11%)
Miscellaneous: Viral infection (nasal inhalation 8% to 14%)
1% to 10%:
Gastrointestinal: Diarrhea, dyspepsia, vomiting
Genitourinary: Dysmenorrhea
Neuromuscular & skeletal: Musculoskeletal pain, myalgia
Ocular: Conjunctivitis
Otic: Otitis media
Respiratory: Asthma, nasal irritation, rhinitis, sinusitis, upper respiratory infection, wheezing
Miscellaneous: Flu-like syndrome
<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, growth suppression, nasal candidiasis, nasal burning, nasal septal perforation, nasal ulcers, oral candidiasis (nasal inhalation), smell disturbance (rare), taste disturbance (rare)
Concentrations may increase with severity of hepatic impairment
Concerns related to adverse effects:
- Adrenal suppression: When recommended doses are exceeded, or in extremely sensitive individuals, may cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. Reports consistent with hypercorticism 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 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 and localized Candida albicans infections of the nose and/or pharynx may occur. Periodically examine nasal mucosa in patients on long term therapy; discontinuation of therapy may be necessary if an infection occurs.
Disease-related concerns:
- Hepatic impairment: Use with caution in patients with hepatic impairment: drug accumulation may increase with severity of hepatic impairment.
- Infections: Use caution or avoid in patients with active or latent tuberculosis or in patients with untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex; worsening of these conditions may occur. 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 hypercorticism (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: 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.
C
Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP 2005; Wallace 2008).
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.
Undetectable in plasma; clinical effects are due to direct local effect, rather than systemic absorption
Hepatic; extensive via CYP3A4 to multiple metabolites
Bile (primary route); urine (limited)
Improvement in allergic rhinitis symptoms may be seen within 11 hours; Maximum effect: Within 1 to 2 weeks after starting therapy
6 hours (IV)
98% to 99%
- 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, or pharyngitis. Have patient report immediately to prescriber signs of infection, severe dizziness, passing out, severe rhinitis, severe nosebleed, nasal sores, wheezing, thrush, severe nausea, severe vomiting, severe loss of strength and energy, 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.