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Mometasone (Oral Inhalation)

Pronunciation

Pronunciation

(moe MET a sone)

Index Terms

  • Mometasone Furoate

Dosage Forms

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

Aerosol, Inhalation, as furoate:

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

Aerosol Powder Breath Activated, Inhalation, as furoate:

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

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

Asmanex 30 Metered Doses: 110 mcg/INH (1 ea); 220 mcg/INH (1 ea) [contains milk protein]

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

Asmanex 7 Metered Doses: 110 mcg/INH (1 ea) [contains milk protein]

Brand Names: U.S.

  • Asmanex 120 Metered Doses
  • Asmanex 14 Metered Doses
  • Asmanex 30 Metered Doses
  • Asmanex 60 Metered Doses
  • Asmanex 7 Metered Doses
  • Asmanex HFA

Pharmacologic Category

  • Corticosteroid, Inhalant (Oral)

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

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

Distribution

Vd: 152 L

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

Excretion

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

Onset of Action

Maximum effects may not be evident for ≥1 to 2 weeks

Time to Peak

Plasma: 0.5 to 2.5 hours

Duration of Action

Duration after discontinuation: Several days or more

Half-Life Elimination

Mean: 5 hours

Protein Binding

98% to 99%

Use: Labeled Indications

Asthma: Maintenance treatment of asthma as prophylactic therapy in patients 4 years and older (Asmanex Twisthaler) and 12 years and older (Asmanex HFA)

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

Guideline recommendations: A low-dose inhaled corticosteroid (in addition to an as-needed short-acting beta-2 agonist) is the initial preferred long-term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach (GINA 2016; NAEPP 2007).

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

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

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

Dosing: Adult

Asthma: Oral inhalation: Note: Dosage forms of Asmanex Twisthaler available in the United States (110 mcg and 220 mcg Twisthaler) deliver 100 and 200 mcg mometasone furoate per actuation respectively. 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.

US labeling:

Previous therapy:

Bronchodilators: Asmanex Twisthaler: Initial: 220 mcg daily (maximum: 440 mcg/day); may be given in the evening or in divided doses twice daily

Inhaled corticosteroids:

Asmanex HFA: Maximum: 400 mcg twice daily (800 mcg/day)

Inhaled medium-dose corticosteroids: Asmanex HFA 100 mcg inhaler: 200 mcg twice daily

Inhaled high-dose corticosteroids: Asmanex HFA 200 mcg inhaler: 400 mcg twice daily

Asmanex Twisthaler: Initial: 220 mcg daily (maximum: 440 mcg/day); may be given in the evening or in divided doses twice daily

Oral corticosteroids: 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 use

Asmanex HFA: Initial: 400 mcg twice daily (maximum: 800 mcg/day)

Asmanex Twisthaler: Initial: 440 mcg twice daily (maximum: 880 mcg/day)

Canadian labeling:

Usual dose: 200 to 400 mcg once daily in the evening or 200 mcg twice daily administered in the morning and evening. Note: Manufacturer suggests that there is a greater chance of achieving asthma control if once-daily dosing is administered in the evening. Some patients (eg, previously receiving high-dose inhaled corticosteroids) may respond more favorably to 400 mcg daily administered in 2 divided doses. Titrate to the lowest effective dose.

Severe asthma and requiring oral corticosteroids: Initial: 400 mcg twice daily administered in the morning and evening (maximum: 800 mcg daily). Taper off oral corticosteroid gradually by decreasing daily prednisone dose by 1 mg daily (or equivalent of other corticosteroid) no sooner than on a weekly basis, beginning after at least 1 week of mometasone use; upon successful taper off of oral steroids, titrate mometasone to lowest effective dose.

Asthma Guidelines: National Asthma Education and Prevention Program guidelines (NAEPP 2007): Dry powder inhaler (refers to Asmanex 200 mcg strength available in U.S.) Note: 220 mcg inhaler delivers 200 mcg mometasone furoate per actuation; NAEPP uses doses based on delivery, while manufacturer recommended doses are based on inhaler amount

“Low” dose: 200 mcg daily

“Medium” dose: 400 mcg daily

“High” dose: >400 mcg daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma: Oral inhalation: Note: Dosage forms of Asmanex Twisthaler available in the United States (110 mcg and 220 mcg Twisthaler) deliver 100 and 200 mcg mometasone furoate per actuation respectively. 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.

Children 4 to 11 years: Asmanex Twisthaler: 110 mcg once daily in the evening (maximum: 110 mcg/day)

Children ≥12 years and Adolescents: Asmanex HFA and Asmanex Twisthaler: Refer to adult dosing.

Asthma Guidelines: National Asthma Education and Prevention Program guidelines (NAEPP 2007): Dry powder inhaler (refers to Asmanex 200 mcg strength available in United States) Note: 220 mcg inhaler delivers 200 mcg mometasone furoate per actuation; NAEPP uses doses based on delivery, while manufacturer recommended doses are based on inhaler amount.

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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.

Administration

Asmanex HFA: Shake well prior to each inhalation. Administer as 2 inhalations twice daily (morning and evening). Prime 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. Clean mouthpiece with a dry wipe after every 7 days of use.

Asmanex Twisthaler: Exhale fully prior to bringing the Twisthaler up to the mouth. Place between lips and inhale quickly and deeply. Do not breathe out through the inhaler. Remove inhaler and hold breath for 10 seconds if possible. Rinse mouth after use.

Dietary Considerations

Asmanex Twisthaler may contain lactose.

Storage

Asmanex HFA: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Discard when the dose counter reads “0".

Asmanex Twisthaler: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Discard when oral dose counter reads "00" (or 45 days after opening the foil pouch).

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Corticosteroids (Orally Inhaled). Management: Orally inhaled fluticasone propionate with a strong CYP3A4 inhibitor is not recommended. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

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. Avoid combination

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Adverse Reactions

>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: 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%)

<1% (Limited to important or life-threatening): Cataract, exacerbation of asthma, glaucoma, growth suppression, hypersensitivity

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism 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. 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 may occur with wheezing after inhalation; may be life-threatening. If this occurs, stop steroid and treat with a fast-acting bronchodilator.

• Hypersensitivity: Reactions including allergic dermatitis, anaphylaxis, angioedema, bronchospasm, flushing, pruritus, rash, and urticaria have been reported; if these symptoms occur, discontinue use.

• 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; active or quiescent tuberculosis infections of the respiratory tract; or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin or pooled intravenous immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles, prophylaxis with pooled intramuscular immunoglobulin may be indicated.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing mometasone therapy. Patients should be instructed to rinse mouth after each use.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Vasculitis: Rare cases of vasculitis (Churg-Strauss syndrome) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Disease-related concerns:

• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.

• 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, anticonvulsants, oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with heart failure; long-term corticosteroid use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; corticosteroids may alter glucose production/regulation leading to hyperglycemia.

• GI disease: Use corticosteroids with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term corticosteroid use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Myocardial infarct (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

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

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur with long-term corticosteroid use.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid patients.

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:

• 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 severe milk protein allergy.

Other warnings/precautions:

• Appropriate use: Prior to use, the dose and duration of treatment should be based on the risk versus benefit for each individual patient. In general, use the smallest effective dose for the shortest duration of time to minimize adverse events. Short-acting beta-2 agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments.

• Discontinuation of systemic corticosteroid therapy: Withdraw systemic corticosteroid therapy with gradual tapering of dose; consider reducing the daily prednisone dose by 2.5 mg on a weekly basis beginning after at least 1 week of inhalation therapy. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.

• Transfer to oral inhaler: When transferring to oral inhaler, previously suppressed allergic conditions (eg, rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions) may be unmasked.

Monitoring Parameters

Growth (adolescents and children via stadiometry); HPA axis suppression; signs/symptoms of oral candidiasis; ocular effects (eg, cataracts, increased intraocular pressure, glaucoma); hepatic impairment; bone mineral density; FEV1, peak flow, and/or other pulmonary function tests

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Based on available data, an overall increased risk of congenital malformations or a decrease in fetal growth has not been associated with maternal use of inhaled corticosteroids during pregnancy (Bakhireva 2005; NAEPP 2005; Namazy 2004). Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy (most information available using budesonide) (ACOG 2008; NAEPP 2005).

Patient Education

• 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, rhinitis, rhinorrhea, pharyngitis, abdominal pain, muscle pain, or back pain. Have patient report immediately to prescriber signs of infection, severe fatigue, irritability, tremors, tachycardia, confusion, dizziness, sweating, thrush, menstrual pain, severe loss of strength and energy, severe nausea, severe vomiting, bone pain, joint pain, flu-like signs, vision changes, difficulty breathing, wheezing, or cough (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.

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