Version July 2025
Note: Atectura Breezhaler is a Canadian product and is not available in the United States.
Asthma, maintenance therapy: Children ≥12 years and Adolescents:
Canadian labeling: Atectura Breezhaler 150 mcg/80 mcg inhalation capsule, 150 mcg/160 mcg inhalation capsule, and 150 mcg/320 mcg inhalation capsule [Canadian products]:
Note: The recommended starting dose is based upon asthma severity and inhaled corticosteroid dosage requirement.
Patients requiring low-dose inhaled corticosteroid and long-acting beta-agonist: Oral inhalation:
Indacaterol 150 mcg/mometasone 80 mcg inhalation capsule: Inhale contents of 1 capsule aerosolized once daily; maximum daily dose: Indacaterol 150 mcg/mometasone 320 mcg/day.
Patients requiring medium or high-dose inhaled corticosteroid and long-acting beta-agonist: Oral inhalation:
Indacaterol 150 mcg/mometasone 160 mcg inhalation capsule OR 150 mcg/mometasone 320 mcg inhalation capsule: Inhale contents of 1 capsule aerosolized once daily; maximum daily dose: Indacaterol 150 mcg/mometasone 320 mcg/day.
Children ≥12 years and Adolescents: No dosage adjustment necessary (Ref).
Children ≥12 years and Adolescents: Based on pharmacokinetic data of individual drug components, no dosage adjustments are needed in patients with mild and moderate liver impairment; use with caution in patients with severe impairment, monitor closely for increased systemic exposure of mometasone (Ref).
(For additional information see "Mometasone and indacaterol (United States: Not available): Drug information")
Asthma, maintenance therapy:
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).
Patients requiring low dose inhaled corticosteroid: Dry powder inhaler (capsule): Oral inhalation: Contents of 1 capsule (indacaterol 150 mcg/mometasone 80 mcg) inhaled once daily (maximum dose: 1 capsule/day).
Patients requiring medium or high dose inhaled corticosteroid: Dry powder inhaler (capsule): Oral inhalation: Contents of 1 capsule (indacaterol 150 mcg/mometasone 160 mcg or indacaterol 150 mcg/mometasone 320 mcg) inhaled once daily (maximum dose: 1 capsule/day).
No dosage adjustment necessary.
No dosage adjustment necessary in patients with mild to moderate impairment. However, mometasone exposure is increased in patients with severe impairment; use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
1% to 10%:
Hypersensitivity: Hypersensitivity reaction (1% to 2%)
Nervous system: Headache (5% to 6%), voice disorder (2%)
Neuromuscular & skeletal: Musculoskeletal pain (3% to 5%)
Respiratory: Oropharyngeal pain (2% to 3%)
<1%:
Cardiovascular: Tachycardia
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Hyperglycemia
Gastrointestinal: Oropharyngeal candidiasis
Hypersensitivity: Angioedema
Neuromuscular & skeletal: Muscle spasm
Hypersensitivity to indacaterol, mometasone, or any component of the formulation.
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: Use of long-acting beta-2 agonists (LABAs) as monotherapy (without inhaled corticosteroids) has been associated with an increased risk of asthma-related death, asthma-related hospitalizations in pediatric and adolescent patients, and an increased risk of severe exacerbations (SMART 2006; Walters 2007). 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 when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current asthma guidelines recommend the use of an as-needed low dose inhaled corticosteroid with formoterol as the preferred reliever agent (GINA 2024).
• Bone density: Long-term use of inhaled corticosteroids has been associated with decreases in bone mineral density (BMD). 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, oral corticosteroids); high doses and/or long-term use of inhaled corticosteroids have been associated with decreases in BMD.
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) 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 IV immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles, prophylaxis with pooled IM immunoglobulin may be indicated.
• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing indacaterol/mometasone therapy. Patients should be instructed to rinse mouth with water without swallowing after each 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 primary care or acute care facility, SABAs are recommended for the acute management of exacerbations (GINA 2023).
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta agonists may cause elevation in BP, 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.
• GI disease: Use corticosteroids with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.
• Hepatic impairment: Monitor patients with severe 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.
• 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 hypothyroidism.
Special populations:
• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter [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: May contain lactose; anaphylactic reactions have been reported in patients with severe milk protein allergy using other lactose-containing powder products.
Other warnings/precautions:
• Discontinuation of systemic corticosteroids: 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.
Not available in the United States.
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Inhalation:
Atectura Breezhaler: Indacaterol acetate 150 mcg and mometasone furoate 80 mcg, Indacaterol acetate 150 mcg and mometasone furoate 160 mcg, Indacaterol acetate 150 mcg and mometasone furoate 320 mcg per inhalation [contains lactose monohydrate]
Canadian labeling:
Oral inhalation (Atectura Breezhaler): For inhalation only; do not swallow capsules. Store capsules in the blister until ready to use to protect from moisture and light; remove immediately before use. Use with the Atectura Breezhaler inhalation device only.
Remove capsule by peeling back the foil on blister card immediately before use (do not push through the foil). Place capsule into the capsule chamber of the Breezhaler device, close inhaler and pierce capsule by pressing and releasing the buttons on the side of the Breezhaler. Exhale fully and then close lips tightly around mouthpiece; do not exhale directly into device. Inhale rapidly and deeply through the mouthpiece to disperse the medication into the airstream; hold breath for up to 5 seconds and exhale slowly. If powder remains in the capsule, repeat rapid, deep breath. Rinse mouth after each use. Discard empty capsule, do not leave it in device. Clean inhaler by wiping the inside and outside clean, with a dry, lint-free cloth; keep Breezhaler dry and do not clean with water; do not handle capsule with wet hands. Discard Breezhaler when all capsules have been used.
Dry powder inhaler: For oral inhalation only (do not swallow capsules); administer at the same time each day. Peel open blister card to remove capsule; do not push capsule through foil or remove capsule from blister until immediately before use. Place capsule directly into capsule chamber of the Breezhaler inhaler; close inhaler and pierce capsule by pressing both side buttons simultaneously once only and then release. Exhale fully (do not exhale into inhaler) then close lips tightly around mouthpiece; inhale a deep breath through the mouthpiece; hold breath for up to 5 seconds. If any powder remains in capsule, exhale and inhale again. Repeat until capsule is empty. Throw away empty capsule; do not leave in inhaler. Following administration, rinse mouth with water after use (do not swallow). If mouthpiece needs cleaning, wipe with a dry, lint-free cloth; keep inhaler dry and never wash with water; do not handle capsules with wet hands. Discard Breezhaler once all capsules have been used.
Store at 15°C to 30°C (59°F to 86°F). Store capsules in blister to protect from moisture and light and only remove immediately before use. Once protective foil is peeled back and/or removed, the capsule should be used immediately; if capsule is not used immediately it should be discarded
Maintenance treatment of asthma (FDA approved in ages ≥12 years and adults).
Note: NOT indicated for the relief of acute bronchospasm.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Atomoxetine: May increase tachycardic effects of Beta2-Agonists. Atomoxetine may increase hypertensive effects of Beta2-Agonists. Risk C: Monitor
Atosiban: Beta2-Agonists may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor
Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification
Benzodiazepines: May increase adverse/toxic effects of Corticosteroids (Orally Inhaled). Specifically, the risk of pneumonia may be increased. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May decrease bronchodilatory effects of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor
Beta-Blockers (Nonselective): May decrease bronchodilatory effects of Beta2-Agonists. Risk X: Avoid
Beta2-Agonists (Long-Acting): May increase adverse/toxic effects of Beta2-Agonists (Long-Acting). Risk X: Avoid
Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Caffeine and Caffeine Containing Products: May increase adverse/toxic effects of Indacaterol. Caffeine and Caffeine Containing Products may increase hypokalemic effects of Indacaterol. Risk C: Monitor
Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects 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: Coadministration of Corticosteroids (Orally Inhaled) and Cosyntropin may alter diagnostic results. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Mometasone (Oral Inhalation). Risk C: Monitor
Desmopressin: Corticosteroids (Orally Inhaled) may increase hyponatremic effects of Desmopressin. Risk X: Avoid
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects 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 increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Loxapine: Agents to Treat Airway Disease may increase adverse/toxic effects 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
Methacholine: Beta2-Agonists (Long-Acting) may decrease therapeutic effects of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider Therapy Modification
Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor
Monoamine Oxidase Inhibitors: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects 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
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Theophylline Derivatives: May increase hypokalemic effects of Beta2-Agonists. Beta2-Agonists may increase adverse/toxic effects of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Risk C: Monitor
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Tobacco (Smoked): May decrease therapeutic effects of Corticosteroids (Orally Inhaled). Risk C: Monitor
Tricyclic Antidepressants: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
Refer to individual monographs.
Monitor growth in pediatric patients. Check mucous membranes for signs of fungal infection. Monitor asthma symptoms, FEV1, peak flow, and/or other pulmonary function tests; hypothalamic-pituitary-adrenal (HPA) axis suppression; ocular effects (eg, cataracts, increased intraocular pressure, glaucoma, central serous chorioretinopathy); bone mineral density. Monitor blood pressure, heart rate, serum glucose, and serum potassium. Monitor for increased use of short-acting beta-2 agonist inhalers; may be marker of a deteriorating asthma condition.
Indacaterol: Relaxes bronchial smooth muscle by selective action on beta-2 receptors with little effect on heart rate; acts locally in the lung.
Mometasone: A corticosteroid that 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.
Note: No significant effect of age was observed in a population pharmacokinetic analysis (Atectura Breezhaler product monograph).
See individual agents.
