Mometasone and Formoterol
Medically reviewed by Drugs.com. Last updated on Jul 28, 2020.
(moe MET a sone & for MOH te rol)
- Eformoterol and Mometasone
- Formoterol and Mometasone
- Formoterol and Mometasone Furoate
- Formoterol Fumarate Dihydrate and Mometasone
- Mometasone and Eformoterol
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, for oral inhalation:
Dulera: Mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg per inhalation (8.8 g, 13 g)
Dulera: Mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg per inhalation (8.8 g, 13 g)
Brand Names: U.S.
- Beta2 Agonist, Long-Acting
- Beta2-Adrenergic Agonist, Long-Acting
- Corticosteroid, Inhalant (Oral)
Formoterol: Relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate. Formoterol has a long-acting effect.
Mometasone: A corticosteroid which controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes/fibroblasts, and reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.
Use: Labeled Indications
Asthma: Treatment of asthma in patients ≥5 years of age
Limitations of use: Not indicated for the relief of acute bronchospasm.
Off Label Uses
Chronic obstructive pulmonary disease (stable)
Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines for the management of chronic obstructive pulmonary disease (COPD), inhaled corticosteroids (ICS) may be considered as part of dual or triple combination therapy (with a long-acting beta agonist [LABA] or with a LABA and long-acting muscarinic antagonist, respectively) in patients with moderate to very severe COPD. However, regular treatment with ICS has been shown to increase the risk of pneumonia, especially in those with severe disease. Combination therapy is recommended in patients with a history of hospitalization(s) for exacerbations of COPD, ≥2 moderate exacerbations of COPD per year, blood eosinophils >300 cells/microliter, and concomitant or history of asthma. Combination therapy may also be considered in patients with 1 moderate exacerbation of COPD per year and blood eosinophils of 100 to 300 cells/microliter [GOLD 2019].
Hypersensitivity to mometasone, formoterol, or any component of the formulation; status asthmaticus or other acute episodes of asthma.
Canadian labeling: Additional contraindications (not in US labeling): Cardiac tachyarrhythmias; untreated systemic fungal, bacterial, viral or parasitic infections, active tuberculous infection of the respiratory tract, or ocular herpes simplex.
Documentation of allergenic cross-reactivity for corticosteroids and/or sympathomimetics are limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Asthma: Note: The recommended starting dose is based upon asthma severity and previous asthma therapy (including inhaled corticosteroid dosage). Titrate to the lowest effective dose (step down) once asthma is well controlled after 2 to 3 months (GINA 2020). The maximum dose is based on the formoterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher mometasone dose per inhalation must be prescribed.
Oral inhalation: Metered-dose inhaler: Two inhalations twice daily of mometasone 100 mcg/formoterol 5 mcg or mometasone 200 mcg/formoterol 5 mcg (maximum dose: mometasone 200 mcg/formoterol 5 mcg [2 inhalations] twice daily).
Chronic obstructive pulmonary disease (stable) (off-label use): Oral inhalation: Metered-dose inhaler: Mometasone 200 mcg/formoterol 10 mcg to mometasone 400 mcg/formoterol 10 mcg twice daily (Doherty 2012; GOLD 2018; GOLD 2019).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Note: Patients receiving mometasone/formoterol twice daily should not use additional formoterol or other inhaled, long-acting beta-2 agonists (eg, arformoterol, salmeterol) for any other reason. The maximum dose is based on the formoterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher mometasone dose per inhalation must be prescribed.
Asthma, maintenance treatment: Note: Initial dose is based on previous asthma therapy, current control, and risk of exacerbation; may increase dose after 2 weeks of therapy in patients who are not adequately controlled; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher mometasone dose per inhalation must be prescribed; titrate to the lowest effective dose once asthma is controlled:
Children 5 years to <12 years: Note: Do not administer more than 2 inhalations twice daily.
Mometasone 50 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.
Children ≥12 years and Adolescents: Note: Do not administer more than 2 inhalations twice daily.
Mometasone 100 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.
Mometasone 200 mcg/formoterol 5 mcg: Oral inhalation: 2 inhalations twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Oral inhalation: Metered-dose inhaler: For oral inhalation only; administer every morning and evening, ~12 hours apart. Prior to first use, prime inhaler by releasing 4 test sprays into the air; shake well before each spray. Inhaler must be reprimed if not used for >5 days; shake well before each use. Discard inhaler after the labeled number of inhalations have been used. Use canister only with provided actuator; do not use with canisters or actuators from other products. Do not remove the canister from the actuator; the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.
Delivery of dose: Place mouthpiece between lips and inhale deeply and hold breath for up to 10 seconds (or as long as you comfortably can); do not exhale through inhaler. Wait ≥30 seconds prior to the second inhalation dose; may use with or without spacer. Rinse mouth/oropharynx with water and spit out rinse solution (without swallowing) after each use. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); temperatures above 49°C (120°F) may cause bursting. Contents under pressure; do not puncture, incinerate, or store near heat or open flame. Discard inhaler after the labeled number of inhalations have been used (the dose counter will read “0”). The 120-actuation inhaler may be stored in any position; store the 60-actuation inhaler with the mouthpiece down or in a horizontal position after priming.
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Avoid combination
Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy
Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Formoterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification
Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Mometasone (Oral Inhalation). Monitor therapy
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy
Inhalational Anesthetics: May enhance the arrhythmogenic effect of Formoterol. Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Loop Diuretics: Beta2-Agonists 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
Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Theophylline Derivatives: May enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Also see individual agents.
1% to 10%:
Central nervous system: Voice disorder (adolescents and adults: 4% to 5%), headache (≥3%)
Infection: Influenza (children: ≥3%)
Respiratory: Nasopharyngitis (adolescents and adults: 5%), upper respiratory tract infection (children: ≥3%), sinusitis (adolescents and adults: 2% to 3%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angina pectoris, angioedema, atrial fibrillation, blurred vision, cardiac arrhythmia, exacerbation of asthma, hyperglycemia, hypertension, hypokalemia, hypotension, oropharyngeal candidiasis, paradoxical bronchospasm, prolonged QT interval on ECG, pruritus, severe hypotension, skin rash, tachyarrhythmia, type I hypersensitivity reaction, type IV hypersensitivity reaction, ventricular premature contractions
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. Do not use this product to transfer patients from oral corticosteroid therapy.
• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggests risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (aged 4 to 11 years) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current guidelines recommend the use of an as-needed low-dose inhaled corticosteroid with formoterol for patients with infrequent symptoms (GINA 2020).
• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (allergic dermatitis, angioedema, bronchospasm, flushing, rash, urticaria) have been reported.
• 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/formoterol therapy. Patients should be instructed to mouth/oropharynx with water (without swallowing) and spit out rinse solution 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.
• Serious effects/fatalities: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.
• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus. In patients presenting to primary care or acute care facility, short-acting beta-2 agonists are recommended for the acute management of exacerbations (GINA 2020).
• Bone density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); high doses and/or long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta-2 agonists may also increase risk of arrhythmias and ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Use with caution following acute myocardial infarction; corticosteroids have been associated with myocardial rupture.
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate ketoacidosis; corticosteroids may alter glucose production/regulation leading to hyperglycemia.
• Gastrointestinal disease: Use corticosteroids with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.
• Hepatic impairment: Monitor patients with hepatic impairment; may lead to accumulation of mometasone.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient), possibly through intracellular shunting.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.
• 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.
• Pheochromocytoma: Use with caution in patients with pheochromocytoma; beta agonists may stimulate the sympathetic nervous system.
• Seizure disorders: Use with caution in patients with seizure disorders; beta agonists may result in CNS stimulation/excitation.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.
• Pediatric: LABAs may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter 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.
• Discontinuation of systemic corticosteroid therapy: Withdraw systemic corticosteroid therapy with gradual tapering of dose. 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.
FEV1, peak flow meter, and/or other pulmonary function tests; monitor growth in pediatric patients, symptom relief, monitor for increased use if short-acting beta2-adrenergic agonists (may be a sign of asthma deterioration); HPA axis suppression; bone mineral density; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium; eye exams (chronic users)
Animal reproduction studies have not been conducted with this combination. See individual agents.
What is this drug used for?
• It is used to treat asthma. This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Throat irritation
• Nasal irritation
• Flu-like symptoms
• Common cold symptoms
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss
• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat
• Chest pain
• Fast heartbeat
• Abnormal heartbeat
• Vision changes
• Severe dizziness
• Passing out
• Severe headache
• Trouble sleeping
• Severe nausea
• Eye pain
• Severe eye irritation
• Loss of strength and energy
• Trouble breathing
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
More about formoterol / mometasone
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 60 Reviews
- Drug class: bronchodilator combinations
- Patient Information
- Mometasone and formoterol Inhalation (Advanced Reading)
- Mometasone and Formoterol
- Other brands
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