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Mometasone (oral inhalation): Drug information

Mometasone (oral inhalation): Drug information
(For additional information see "Mometasone (oral inhalation): Patient drug information" and see "Mometasone (oral inhalation): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Asmanex (120 Metered Doses);
  • Asmanex (14 Metered Doses);
  • Asmanex (30 Metered Doses);
  • Asmanex (60 Metered Doses);
  • Asmanex (7 Metered Doses) [DSC];
  • Asmanex HFA
Brand Names: Canada
  • Asmanex Twisthaler
Pharmacologic Category
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult
Asthma, maintenance/controller

Asthma, maintenance/controller: Note: Product selection: Individualize daily mometasone dose based on severity of symptoms, typically as follows: low doses for mild persistent asthma; low to medium doses for moderate persistent asthma; and medium to high doses for severe persistent asthma. Select a product with a favorable dosage per actuation to improve convenience and adherence (Ref).

Dosage Classification for Mometasone Preparationsa

Low to medium dose

High dose

a GINA 2023

Mometasone

200 to 400 mcg/day

>400 mcg/day

Asmanex HFA: Metered-dose inhaler:

Patients who are not on an inhaled corticosteroid: Oral inhalation: Mometasone 100 mcg: Initial: 200 mcg twice daily; maximum dose: 800 mcg/day.

Patients currently receiving chronic oral corticosteroids: Oral inhalation: Mometasone 200 mcg: Initial: 400 mcg twice daily; maximum dose: 800 mcg/day.

Asmanex Twisthaler: Dry powder inhaler: Note: The 440 mcg daily dose may be administered in divided doses or as once daily.

Patients who previously received bronchodilators alone: Oral inhalation: Initial: 220 mcg once daily in the evening; maximum dose: 440 mcg/day.

Patients who previously received inhaled corticosteroids: Oral inhalation: Initial: 220 mcg once daily in the evening; maximum dose: 440 mcg/day.

Patients who previously received oral corticosteroids: Oral inhalation: Initial: 440 mcg twice daily; maximum dose: 880 mcg/day. Note: Prednisone should be reduced slowly (ie, no faster than 2.5 mg daily on a weekly basis), beginning after at least 1 week of mometasone therapy.

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

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, mometasone exposure may increase with severity of hepatic impairment.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Mometasone (oral inhalation): Pediatric drug information")

Asthma

Asthma: Note: Asmanex Twisthaler (110 mcg and 220 mcg Twisthaler) deliver 100 and 200 mcg mometasone furoate per actuation respectively; NAEPP uses doses based on delivery dose, while manufacturer recommended doses are based on inhaler amount. Maximum effects may not be evident for 1 to 2 weeks or longer; higher doses may provide additional asthma control in patients who do not respond adequately after 2 weeks of therapy. Doses should be titrated to the lowest effective dose once asthma is controlled.

Maintenance therapy:

Asmanex Twisthaler (dry powder inhaler):

Children 4 to 11 years (regardless of prior therapy): Note: Use 110 mcg inhaler: Oral inhalation (110 mcg/inhalation): Initial: 110 mcg once daily, administered in the evening. Maximum daily dose: 110 mcg/day.

Children ≥12 years and Adolescents: Dosing based on previous asthma therapy:

Patients previously treated with bronchodilators alone or with inhaled corticosteroids: Oral inhalation (220 mcg/inhalation): Initial: 220 mcg once daily, administered in the evening; may increase dose after 2 weeks if adequate response not obtained. Maximum daily dose: 440 mcg/day; may be administered as 1 inhalation twice daily or 2 inhalations once daily in the evening.

Patients previously treated with oral corticosteroids: Oral inhalation (220 mcg/inhalation): Initial: 440 mcg twice daily. Maximum daily dose: 880 mcg/day.

Asmanex HFA:

Children 5 to <12 years: Oral inhalation (50 mcg/inhalation): 100 mcg twice daily; maximum daily dose: 200 mcg/day.

Children ≥12 years and Adolescents: Note: Dosing based on previous asthma therapy:

Patients previously treated with inhaled medium dose corticosteroid: Oral inhalation (100 mcg/inhalation): 200 mcg twice daily; maximum daily dose: 800 mcg/day.

Patients previously treated with high-dose inhaled corticosteroids or oral corticosteroids: Oral inhalation (200 mcg/inhalation): 400 mcg twice daily; maximum daily dose: 800 mcg/day.

Asthma guidelines:

Global Initiative for Asthma Guidelines (Ref): Dry powder inhaler (refers to Asmanex Twisthaler 110 mcg and 220 mcg strengths):

Children 6 to 11 years: Oral inhalation:

“Low” dose: 110 mcg/day.

“Medium” dose: ≥220 to <440 mcg/day.

“High” dose: ≥440 mcg/day.

Children ≥12 years and Adolescents: Oral inhalation:

“Low” dose: 110 to 220 mcg/day.

“Medium” dose: >220 to 440 mcg/day.

“High” dose: >440 mcg/day.

National Asthma Education and Prevention Program (Ref): Dry powder inhaler (refers to Asmanex Twisthaler 220 mcg strength): Children ≥12 years and Adolescents: Oral inhalation:

"Low" dose: 200 mcg/day.

"Medium" dose: 400 mcg/day.

"High" dose: >400 mcg/day.

Mild flare, exacerbation: Limited data available:

Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:

It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (Ref). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (Ref). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (Ref).

Conversion from oral systemic corticosteroids to orally-inhaled corticosteroids: When using mometasone oral inhalation to help reduce or discontinue oral corticosteroid therapy, begin prednisone taper after at least 1 week of mometasone inhalation therapy; prednisone should be tapered slowly (ie, no faster than 2.5 mg/day on a weekly basis); monitor patients for signs of asthma instability and adrenal insufficiency; decrease mometasone to lowest effective dose after prednisone reduction is complete.

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

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, mometasone exposure may increase with severity of hepatic impairment.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (3% to 22%), fatigue (1% to 13%), depression (11%)

Gastrointestinal: Oral candidiasis (≤22%)

Neuromuscular & skeletal: Musculoskeletal pain (8% to 22%), arthralgia (13%)

Respiratory: Sinusitis (3% to 22%), allergic rhinitis (adolescents & adults 14% to 20%; children 4%), upper respiratory tract infection (8% to 15%), pharyngitis (8% to 13%)

1% to 10%:

Central nervous system: Pain (1% to <3%)

Gastrointestinal: Abdominal pain (3% to 6%), dyspepsia (5%), nausea (3%), vomiting (1% to ≤3%), anorexia (1% to <3%), gastroenteritis (1% to <3%)

Genitourinary: Dysmenorrhea (9%), urinary tract infection (children 2%)

Hematologic & oncologic: Bruise (children 2%)

Infection: Influenza (4%), infection (1% to <3%)

Neuromuscular & skeletal: Back pain (6%), myalgia (3%)

Ophthalmic: Increased intraocular pressure (3%)

Otic: Otalgia (1% to <3%)

Respiratory: Paranasal sinus congestion (9%), nasopharyngitis (5% to 8%), bronchitis (3%), dry throat (1% to <3%), epistaxis (1% to <3%), flu-like symptoms (1% to <3%), nasal discomfort (1% to <3%), voice disorder (1% to <3%)

Miscellaneous: Fever (children 7%)

Postmarketing and/or case reports: Anaphylaxis, angioedema, blurred vision, bronchospasm, cataract, cough, dyspnea, exacerbation of asthma, glaucoma, growth retardation, hypersensitivity reaction, pruritus, skin rash, wheezing

Contraindications

Hypersensitivity to mometasone or any component of the formulation; hypersensitivity to milk proteins (Asmanex Twisthaler only); primary treatment of status asthmaticus or other acute episodes of asthma for which intensive measures are required

Canadian labeling: Additional contraindications (not in US labeling): Untreated systemic fungal, bacterial, viral, or parasitic infections; tuberculosis (TB) disease (active TB) or infection (latent TB) of the respiratory tract; ocular herpes simplex.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. 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 (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroids should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue mometasone and institute alternative therapy.

• Hypersensitivity: Hypersensitivity reactions (eg, allergic dermatitis, anaphylaxis, angioedema, bronchospasm, flushing, pruritus, rash, urticaria) may occur; discontinue use if reaction occurs.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use if possible in patients with ocular herpes; respiratory tuberculosis (TB) disease (active TB) or infection (latent TB); or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intravenous immunoglobulin, respectively, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water (without swallowing) and spit after each use.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute asthma episodes requiring intensive measures.

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, antiseizure medication, oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; blurred vision, increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in long-term users.

Special populations:

• Pediatrics: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 cm per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: Asmanex Twisthaler: May contain lactose; very rare anaphylactic reactions have been reported in patients with milk protein allergy.

Other warnings/precautions:

• Discontinuation of systemic corticosteroid therapy: 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 oral inhalation therapy.

• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.

Warnings: Additional Pediatric Considerations

Although recommended in children ≥12 years and adolescents, using higher doses (quintupled) in children <12 years of age has not shown efficacy and may be associated with a higher risk of adverse effects. A study in children 5 to 11 years of age with mild to moderate persistent asthma evaluated quintupling the dose of the inhaled corticosteroid (fluticasone) following the early signs of decreased asthma control; results showed that quintupled fluticasone dosages did not reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (Jackson 2018).

Dosage Forms Considerations

Asmanex HFA inhaler delivers 120 actuations.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol, Inhalation, as furoate:

Asmanex HFA: 50 mcg/actuation (13 g); 100 mcg/actuation (13 g); 200 mcg/actuation (13 g)

Aerosol Powder Breath Activated, Inhalation, as furoate:

Asmanex (120 Metered Doses): 220 mcg/actuation (1 ea) [contains lactose, milk protein]

Asmanex (120 Metered Doses): 220 mcg/actuation (1 ea [DSC]) [contains milk protein]

Asmanex (14 Metered Doses): 220 mcg/actuation (1 ea) [contains lactose, milk protein]

Asmanex (14 Metered Doses): 220 mcg/actuation (1 ea [DSC]) [contains milk protein]

Asmanex (30 Metered Doses): 110 mcg/actuation (1 ea) [contains lactose, milk protein]

Asmanex (30 Metered Doses): 110 mcg/actuation (1 ea [DSC]) [contains milk protein]

Asmanex (30 Metered Doses): 220 mcg/actuation (1 ea) [contains lactose, milk protein]

Asmanex (30 Metered Doses): 220 mcg/actuation (1 ea [DSC]) [contains milk protein]

Asmanex (60 Metered Doses): 220 mcg/actuation (1 ea) [contains lactose, milk protein]

Asmanex (60 Metered Doses): 220 mcg/actuation (1 ea [DSC]) [contains milk protein]

Asmanex (7 Metered Doses): 110 mcg/actuation (1 ea [DSC]) [contains lactose, milk protein]

Generic Equivalent Available: US

No

Pricing: US

Aerosol (Asmanex HFA Inhalation)

50 mcg/ACT (per gram): $8.59

100 mcg/ACT (per gram): $9.26

200 mcg/ACT (per gram): $10.89

Aerosol powder (Asmanex (120 Metered Doses) Inhalation)

220 mcg/ACT (per each): $202.73

Aerosol powder (Asmanex (14 Metered Doses) Inhalation)

220 mcg/ACT (per each): $46.56

Aerosol powder (Asmanex (30 Metered Doses) Inhalation)

110 mcg/ACT (per each): $111.65

220 mcg/ACT (per each): $120.56

Aerosol powder (Asmanex (60 Metered Doses) Inhalation)

220 mcg/ACT (per each): $141.48

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.

Dosage Forms: Canada

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

Aerosol Powder Breath Activated, Inhalation:

Asmanex Twisthaler: 100 mcg/actuation (1 ea); 200 mcg/actuation (1 ea); 400 mcg/actuation (1 ea) [contains lactose]

Administration: Adult

Asmanex HFA: Metered-dose inhaler: Shake well prior to each inhalation. Administer as 2 inhalations twice daily (morning and evening). Prime before first use and when the inhaler has not been used for >5 days by releasing 4 test sprays into the air, away from the face, shaking well before each spray. Rinse mouth with water (without swallowing) and spit after each use. Clean mouthpiece with a dry wipe after every 7 days of use.

Asmanex Twisthaler: Dry-powder inhaler: When administered once daily, administer only in the evening. Exhale fully, then place mouthpiece in mouth holding it in a horizontal position and inhale quickly and deeply. Remove inhaler and hold breath for 10 seconds if possible. Do not breathe out through the inhaler. Rinse mouth after use.

Administration: Pediatric

Oral inhalation:

Asmanex Twisthaler (Dry powder inhaler): Remove inhaler from foil pouch; write date on cap label. Keep inhaler upright while removing cap, twisting in a counterclockwise direction; lifting the cap loads the device with the medication. Exhale fully prior to bringing the inhaler up to the mouth. Place inhaler in mouth, while holding it in a horizontal position. Close lips around the mouthpiece and inhale quickly and deeply. Remove the inhaler from your mouth and hold your breath for about 10 seconds, if possible. Do not exhale into inhaler. Wipe the mouthpiece dry and replace the cap immediately after each inhalation; rotate fully until click is heard. Rinse mouth with water (without swallowing) after inhalation to decrease chance of oral candidiasis. Avoid contact of the inhaler with any liquids; do not wash; wipe with dry cloth or tissue if needed. Discard the inhaler 45 days after opening foil pouch or when dose counter reads "00."

Asmanex HFA (Metered dose inhaler): Shake well prior to use; administer as 2 inhalations twice daily (morning and evening). Prime the inhaler before first use by releasing 4 test sprays into the air, away from the face, shaking well before each spray. If the inhaler has not been used for more than 5 days, prime the inhaler again with 4 test sprays. Rinse mouth with water without swallowing (decreases the chance of oral candidiasis). Do not wash inhaler with water; clean mouthpiece using a dry cloth every 7 days and discard inhaler after the counter reaches “0”.

Use: Labeled Indications

Asthma, maintenance/controller: Maintenance treatment of asthma as prophylactic therapy in patients ≥4 years of age (Asmanex Twisthaler) and ≥5 years of age (Asmanex HFA).

Limitations of use: Not indicated for the relief of acute bronchospasm.

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

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.

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Mometasone (Oral Inhalation). Risk C: Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Reproductive Considerations

Uncontrolled asthma may negatively affect fertility by increasing time to pregnancy and reducing birth rate. Fertility may be improved in patients adequately treated with inhaled corticosteroids (Couillard 2021; ERS/TSANZ [Middleton 2020]). Inhaled corticosteroids used for the treatment of asthma should not be discontinued in patients planning to become pregnant (GINA 2023). The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]).

Pregnancy Considerations

Maternal use of inhaled corticosteroids (ICS) in usual doses is not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following high maternal doses of an alternative inhaled corticosteroid (ERS/TSANZ [Middleton 2020]).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2023).

Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy. Due to the risk of exacerbations, stepping down or stopping ICS should not be done during pregnancy (GINA 2023). Mometasone oral inhalation is considered probably acceptable for use during pregnancy. Pregnant patients adequately controlled on mometasone for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant patients may be preferred. The lowest dose that maintains asthma control should be used. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or http://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if mometasone is present in breast milk following oral inhalation; however, oral absorption is limited (<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.

Mometasone oral inhalation is considered probably acceptable with breastfeeding (ERS/TSANZ [Middleton 2020]).

Dietary Considerations

Asmanex Twisthaler may contain lactose.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density; growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Maximum effects may not be evident for ≥1 to 2 weeks

Duration after discontinuation: Several days or more

Absorption: <1%; clinical effects are due to direct local effect, rather than systemic absorption

Distribution: Vd: 152 L

Protein binding: 98% to 99%

Metabolism: Extensive in the liver to multiple metabolites; no major metabolites are detectable in the plasma; in vitro incubation studies identified one minor metabolite, 6 Beta-hydroxymometasone furoate, formed via cytochrome P450 CYP3A4 pathway

Bioavailability: Single dose: <1%

Half-life elimination: Mean: 5 hours

Time to peak, plasma: 0.5 to 2.5 hours

Excretion: Feces (~74%), urine (~8%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Avocom | Momate | Mometix AQ | Nasehaler | Nasonex | Natazone | Rinelon | Sinocort | Tabunex;
  • (AR) Argentina: Fenisona | Hexaler | Lisiker | Metason | Nasonex | Suavicort | Uniclar;
  • (AT) Austria: Mometason cipla | Mometason Hexal | Mometason ratiopharm | Nasonex;
  • (AU) Australia: Amcal mometasone nasal allergy relief | Apo mometasone | Azonaire | Blooms the chemist mometasone nasal allergy relief | Chemmart mometasone | Medifess | Metaspray | Nasonex | Nasonex allergy | Pharmacy care mometasone nasal allergy relief | Pharmacy choice hayfever prevention & relief | Priceline pharmacy mometasone allergy relief | Sensease nasal allergy relief | Telnasal | Terry white chemists mometasone | Uniclar aqueous nasal spray;
  • (BD) Bangladesh: Metaspray | Momeson | Nasomet | Nasonex;
  • (BE) Belgium: Momepax | Mometasone cipla | Mometasone sandoz | Mometasone teva | Mometeva;
  • (BF) Burkina Faso: Nasehaler | Nasonex;
  • (BG) Bulgaria: Bloctimo | Etacid | Kalmente | Momanose | Mometasone | Nasonex | Nasostad;
  • (BR) Brazil: Amome | Furoato de mometasona | Momate | Monax | Nasonex | Nites | Ventus;
  • (CH) Switzerland: Mometason mepha | Mometason pollen sandoz | Mometason spirig hc | Mometasonfuroat sandoz;
  • (CI) Côte d'Ivoire: Nasehaler;
  • (CL) Chile: Dimuxon | Monez | Nasonex | Pluster | Rinitek | Rinomase | Rinoval | Suavicort | Synaller | Uniclar;
  • (CN) China: Nasonex;
  • (CO) Colombia: Biometasona | Broner | Furoato de mometasona | Furomet | Metaspray | Momenase | Mometasona | Mometasyn | Mometasyn free | Nasonex | Rhinospray | Rinosal | Rinosona | Uniclar;
  • (CZ) Czech Republic: Asmanex | Momanose | Momespir | Mometason furoat actavis | Mometason furoat cipla | Mommox | Nasonex;
  • (DE) Germany: Allergo momelind | Aphiasone | Momeallerg | Momegalen | Momekort | Mometadex | Mometahexal | Mometason beta | Mometason ratiopharm heuschnupfenspray | Mometasonfuroat AbZ | Mometasonfuroat al | Mometasonfuroat ratiopharm | Nasonex | Vividrin Mometason;
  • (DO) Dominican Republic: Aguanace | Furonasal | Metaspray | Mometasona sandoz | Mometasyn | Mometasyn free | Mommex | Nasonex | Plermin | Rinetason | Rinix | Rinobudex | Rinolerg | Uniclar;
  • (EC) Ecuador: Furoato de mometasona | Metacross | Metasone | Momate ns | Mometasona | Mometasona la sante | Monez | Nasonex | Plenium | Rinetason | Rinobudex | Rinoval | Uniclar;
  • (EE) Estonia: Breso | Kalmente | Mometasone sanoswiss | Nasometin | Nasonex;
  • (EG) Egypt: Nasonex | Norhinose | Tabunex;
  • (ES) Spain: Mometasona | Mometasona aldo union | Mometasona furoato cinfa | Mometasona furoato cipla | Mometasona furoato Stadagen | Mometasona furoato vir | Mometasona kern | Mometasona sandoz | Mometasona teva | Nasoaldo | Nasonex | Rinelon;
  • (ET) Ethiopia: Etacid | Nasonex | Tabunex;
  • (FI) Finland: Momesonex | Mometasone actavis | Mometasone cipla | Mometasone orion | Mommox | Nasonex | Nenoxin;
  • (FR) France: Mometasone arrow | Mometasone biogaran | Mometasone cristers | Mometasone eg | Mometasone gerda | Mometasone mylan | Mometasone sandoz | Mometasone zentiva | Nasonex;
  • (GB) United Kingdom: Asmanex | Clarinaze allergy | Mometasone | Mometasone teva | Nasonex;
  • (GR) Greece: Mometasone target | Nasonex;
  • (HK) Hong Kong: Apo mometasone | Metaspray | Momeson | Nasonex;
  • (HR) Croatia: Bloctimo;
  • (HU) Hungary: Bloctimo | Kalmente | Mometason pannonpharma | Mometason Sandoz | Mometasone cipla | Nasonex | Nasotasone;
  • (ID) Indonesia: Modexa | Nasonex;
  • (IE) Ireland: Nasonex | Rhinex relief;
  • (IL) Israel: Nasonex;
  • (IN) India: Aquamet | Ezispray | M-Spray | Megaspray | Metaspray | Metatop | Momefit | Momenta | Momist | Msone | Nasonex | Nazomac M | Respizen | Sensonase;
  • (IT) Italy: Brexcort | Brusonex | Calimix | Emmarin | Exicort | Metacort | Momecort | Mometasone cipla | Mometasone eurogenerici | Mometasone furoato sandoz | Mometasone teva | Mometasone zentiva | Momil | Nasonex | Rinelon | Rinoff | Uniclar;
  • (JO) Jordan: Alivio | Aresil | Nasonex | Sinocort | Tabunex;
  • (JP) Japan: Mometasone ceo | Mometasone jg | Mometasone kyorin | Mometasone myl | Mometasone nitto | Mometasone takata | Mometasone towa | Nasonex;
  • (KE) Kenya: Momate | Momecort | Momeson | Nasonex | Rhinizill | Sinocort;
  • (KR) Korea, Republic of: Alernasal | Antirun | Aranex | Biconex | Biconex nasal | Bizonex | Br conex | Ckd mometasone furoate | Cobinex | Cobizal | Coco | Coetasone | Coezal | Cozalnex | I meta | Jw mometasone | Kometasone | Mobeta | Momeco | MomeCT | Momet | Mometal | Mometaon | Mometasone | Monasone | Monitazon | Moritasone nasal | Motanex | Motesone | Nacodrin | Narinex | Nasacare | Nasativ | Nasative | Nasoclean | Nasocobi | Nasocure | Nasomega | Nasomesone | Nasonex | Nasotasone | Nazatasone | Nazocobi | Nazometa | Neriex | New naso a | Nezelex | Raninex | Rb pro | Rhinex | Rhinonex | Samsung mometasone | Schnell | Zalconex;
  • (KW) Kuwait: Mometix AQ | Nasonex aqueous | Tabunex;
  • (LB) Lebanon: Avocom | Metasone | Metaspray | Nasonex | Sinocort | Tabunex;
  • (LT) Lithuania: Breso | Kalmente | Mometasone furoate sandoz | Mometasone inteli | Mometasone sandoz | Mometasone teva | Nasometin | Nasonex;
  • (LU) Luxembourg: Mometasone sandoz | Nasonex;
  • (LV) Latvia: Breso | Mometasone teva | Nasometin | Nasonex;
  • (MA) Morocco: Metanaz | Nasonex | Risonel | Tabunex;
  • (MX) Mexico: Akira | Alegoria | Dimuxon | Dirnelid | Dutina | Levante | Modinaxfar | Mofhinis | Mometasona | Quimafron | Rinelon | Uniclar;
  • (MY) Malaysia: Apo mometasone furoate | Axcel mometasone | Elonide | Metaspray | Momate | Nasehaler | Nasonex;
  • (NL) Netherlands: Mometason Furoaat | Mometasonfuroaat Aurobindo | Mometasonfuroaat cf | Mometasonfuroaat Cipla | Mometasonfuroaat fisher | Mometasonfuroaat Sandoz | Mometasonfuroaat teva | Nasonex;
  • (NO) Norway: Mometason cipla | Mometason ratiopharm | Mometasone sandoz | Nasonex;
  • (NZ) New Zealand: Azonaire;
  • (PE) Peru: Momate | Mometasyn | Mometax n | Nasonex | Nasonex pediatrico | Plermin | Rinelon | Rinobudex | Suavicort;
  • (PH) Philippines: Metaspray | Momate | Mosaspray | Nasonex | Rinelon | Zymocort;
  • (PK) Pakistan: Hivate | Mms | Nasomet | Rinelon;
  • (PL) Poland: Aleric | Eztom | Hitaxa metmin | Momester | Nasehaler | Nasometin | Nasometin Control | Nasonex | Pronasal;
  • (PR) Puerto Rico: Asmanex hfa | Nasonex;
  • (PT) Portugal: Mometasona alter | Mometasona generis | Mometasona Ratiopharm | Mometasona sandoz | Mometasona teva | Nasomet | Rhinizill;
  • (PY) Paraguay: Aerostan | Alersona | Hexaler nasal | Metason | Momenta | Momesona | Mometasyn free | Nasolin | Rinoval | Suavicort;
  • (QA) Qatar: Asmanex Twisthaler;
  • (RO) Romania: Kalmente | Mometazona teva;
  • (RU) Russian Federation: Dezrinit | Momate rhino | Momenza | Mometasone sandoz | Momezal allergo | Nasonex | Nozefrin;
  • (SA) Saudi Arabia: Avocom | Defonex | Momate | Nasonex | Nosco | Tabunex | Tasonex;
  • (SE) Sweden: Aphiahsone | Momenex | Mometason ABECE | Mometason apofri | Mometason Evolan | Mometasone actavis | Mometasone orion | Mometasone teva | Mommox | Nasonex | Orimox;
  • (SG) Singapore: Mometasone sandoz | Nasonex;
  • (SI) Slovenia: Mommox | Mommox rino | Nasonex;
  • (SK) Slovakia: Mometasone actavis | Mometasone furoate cipla | Mometasone sandoz | Mometazon teva | Nasometin | Nasonex;
  • (TH) Thailand: Mometasone sandoz | Nasonex | Rinelon;
  • (TN) Tunisia: Mesone | Nasomet | Nasonex | Risomax | Sinocort;
  • (TR) Turkey: Avixonel | Etacid | K allexin | Momecon | Mometix AQ | Monaliz | Myrey | Nasonex | Nazofix | Risonel;
  • (TW) Taiwan: Momenase;
  • (UA) Ukraine: Allertec nazo | Asmanex | Canomen | Etacid | Flix | Forinex | Glenspray | Mometason teva | Mometasone | Momixon | Nasonex | Nasonex sinus;
  • (UG) Uganda: Momenap | Nasehaler | Nasonex;
  • (UY) Uruguay: Nasonex | Suavicort;
  • (VE) Venezuela, Bolivarian Republic of: Elocon | Metaspray | Momnase | Nasoaldo | Nasonex | Nimarin | Uniclar;
  • (VN) Viet Nam: Mome Air;
  • (ZA) South Africa: Mometasone clicks | Monact | Nasonex aqueous | Nexomist | Rinelon | Zilfone;
  • (ZM) Zambia: Momenap;
  • (ZW) Zimbabwe: Nasehaler
  1. Asmanex HFA (mometasone furoate) [prescribing information]. Whitehouse Station, NJ: Merck & Co; August 2019.
  2. Asmanex Twisthaler (mometasone furoate) [prescribing information]. Whitehouse Station, NJ: Merck & Co; September 2014.
  3. Asmanex Twisthaler (mometasone furoate) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021.
  4. Asmanex Twisthaler (mometasone furoate) [product monograph]. Kirkland, Quebec, Canada: Organon Canada Inc; April 2021.
  5. Bakhireva LN, Jones KL, Schatz M, et al, “Asthma Medication Use in Pregnancy and Fetal Growth,” J Allergy Clin Immunol, 2005, 116(3):503-9. [PubMed 16159616]
  6. Couillard S, Connolly C, Borg C, Pavord I. Asthma in pregnancy: an update. Obstet Med. 2021;14(3):135-144. doi:10.1177/1753495X20965072 [PubMed 34646341]
  7. Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. Updated 2017.
  8. Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Updated 2019. Accessed December 13, 2019.
  9. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
  10. Goedert JJ, Vitale F, Lauria C, et al. Risk Factors for Classical Kaposi's Sarcoma. J Natl Cancer Inst. 2002;94(22):1712-1718. [PubMed 12441327]
  11. Jackson DJ, Bacharier LB, Mauger DT, et al. Quintupling inhaled glucocorticoids to prevent childhood asthma exacerbations. N Engl J Med. 2018;378(10):891-901. [PubMed 29504498]
  12. McKeever T, Mortimer K, Wilson A, et al. Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. N Engl J Med. 2018;378(10):902-910. doi:10.1056/NEJMoa1714257 [PubMed 29504499]
  13. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019 [PubMed 31699837]
  14. National Asthma Education and Prevention Program (NAEPP), Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
  15. Todd GR, Acerini CL, Buck JJ, et al, "Acute Adrenal Crisis in Asthmatics Treated With High-Dose Fluticasone Propionate," Eur Respir J, 2002, 19(6):1207-9. [PubMed 12108877]
  16. Todd GR, Acerini CL, Ross-Russell R, et al, "Survey of Adrenal Crisis Associated With Inhaled Corticosteroids in the United Kingdom," Arch Dis Child, 2002, 87(6):457-61. [PubMed 12456538]
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