Version May 2024
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). 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.
Metered-dose inhaler: Oral inhalation: 2 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, maintenance (off-label use):
Note: Use of long-acting beta agonist and inhaled corticosteroid is not encouraged. In patients with persistent exacerbations on dual long-acting bronchodilator therapy or elevated eosinophil count (group E), consider triple therapy (inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Metered-dose inhaler (mometasone 100 mcg/formoterol 5 mcg per actuation): Oral inhalation: 2 inhalations twice daily; in patients with persistent symptoms or exacerbations, may change to mometasone 200 mcg/formoterol 5 mcg per actuation 2 inhalations twice daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, mometasone exposure is increased with severity of hepatic impairment.
Refer to adult dosing.
(For additional information see "Mometasone and formoterol: Pediatric drug information")
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 therapy: 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.
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 (has not been studied); however, mometasone systemic exposure is increased with hepatic impairment.
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
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.
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).
• 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; tuberculosis (TB) infection (latent TB) or disease (active TB) 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.
Disease-related concerns:
• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus. For acute asthma exacerbations, budesonide/formoterol is preferred as a reliever; however, short-acting beta-2 agonists (SABAs) may be used. In patients presenting to a primary care or acute care facility, SABAs are recommended for the acute management of exacerbations (GINA 2023).
• 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, antiseizure medications 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.
Special populations:
• 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.
Other warnings/precautions:
• 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.
Dulera 8.8 g canisters contain 60 inhalations; 13 g canisters contain 120 inhalations.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, for oral inhalation:
Dulera: Mometasone furoate 50 mcg and formoterol fumarate dihydrate 5 mcg per inhalation (13 g); Mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg per inhalation (8.8 g, 13 g); Mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg per inhalation (8.8 g, 13 g)
No
Aerosol (Dulera Inhalation)
50-5 mcg/ACT (per gram): $31.63
100-5 mcg/ACT (per gram): $31.63
200-5 mcg/ACT (per gram): $31.63
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, for oral inhalation:
Zenhale: Mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg per inhalation; Mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg per inhalation
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.
Oral inhalation: Prior to first use, inhaler must be primed 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. Rinse mouth after 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. The canister should not be removed from the actuator because 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 gently between teeth, closing lips around inhaler. Inhale deeply and hold breath held for 5 to 10 seconds. The amount of drug delivered is small, and the individual will not sense the medication as it is inhaled. Remove mouthpiece from mouth prior to exhalation. Do not breathe out through the mouthpiece. Wait at least 30 seconds prior to the second inhalation dose. After use of the inhaler, rinse mouth/oropharynx with water and spit out rinse solution.
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM217561.pdf; must be dispensed with this medication.
Asthma, maintenance/controller: Treatment of asthma in patients ≥5 years of age.
Limitations of use: Not indicated for the relief of acute bronchospasm.
Chronic obstructive pulmonary disease, maintenance
Refer to individual components.
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.
Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk C: Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: 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. Risk C: Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination
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. Risk C: Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk D: Consider therapy modification
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
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination
Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: 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. Risk X: 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. Risk D: Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
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. Risk C: Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Animal reproduction studies have not been conducted with this combination. See individual agents.
It is not known if mometasone or formoterol 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. Refer to individual agents.
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)
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.
See individual agents.
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