Version July 2025
Asthma, maintenance therapy:
Dry powder inhaler (indacaterol 150 mcg/glycopyrrolate 50 mcg/mometasone 160 mcg per capsule): Oral inhalation: Contents of 1 capsule inhaled once daily (maximum dose: 1 capsule/day).
eGFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; glycopyrrolate systemic exposure may be increased.
End-stage renal disease requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; glycopyrrolate systemic exposure may be increased.
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use with caution; mometasone systemic exposure may be increased.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
1% to 10%:
Cardiovascular: Tachycardia (1%)
Gastrointestinal: Gastroenteritis (3%)
Genitourinary: Urinary tract infection (4%)
Hypersensitivity: Hypersensitivity reaction (1%)
Nervous system: Headache (4%), voice disorder (4%)
Neuromuscular & skeletal: Muscle spasm (2%), musculoskeletal pain (3%)
Respiratory: Cough (4%), oropharyngeal pain (3%)
Miscellaneous: Fever (3%)
<1%:
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Hyperglycemia
Gastrointestinal: Xerostomia
Genitourinary: Dysuria
Infection: Candidiasis
Hypersensitivity to indacaterol, glycopyrrolate, 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: 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.
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.
• 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 (active or latent); or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled immunoglobulin, respectively, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing therapy.
• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; 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 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: 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 2024).
• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, arrhythmias, and hypertension; beta agonists may cause elevation in BP and heart rate. Beta-2 agonists may also cause ECG changes (eg, T-wave flattening, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate ketoacidosis.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism; beta-2 agonists may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).
• Kidney function impairment: Use with caution in patients with severe kidney impairment (eGFR <30 mL/minute/1.73 m2) or end-stage kidney disease on dialysis; monitor closely.
• Liver impairment: Use with caution in patients with severe liver impairment; may lead to accumulation of mometasone.
• Ocular disease: Use with caution in patients with increased intraocular pressure, cataracts, and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.
• Prostatic hyperplasia/bladder neck obstruction: May worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction (eg, painful urination, difficulty passing urine); use with caution.
• Seizure disorders: Use with caution in patients with seizure disorders; beta agonists may result in CNS stimulation/excitation.
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: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
Not available in the US.
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Inhalation:
Enerzair Breezhaler: Indacaterol 150 mcg, glycopyrronium 50 mcg, and mometasone 160 mcg [contains lactose monohydrate]
Oral inhalation: 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. Do not remove capsule from blister until immediately before use. Place capsule directly into capsule chamber of the Enerzair 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 and exhale slowly. 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). Clean mouthpiece by wiping with a dry, lint-free cloth; keep inhaler dry and do not wash with water; do not handle capsules with wet hands. Discard Enerzair Breezhaler once all capsules have been used.
Note: Not approved in the US.
Asthma: Maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and a medium or high dose of an inhaled corticosteroid who experienced ≥1 asthma exacerbations in the previous 12 months.
Limitations of use: Not indicated for 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.
Agents with Clinically Relevant Anticholinergic Effects: May increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
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
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
Inhaled Anticholinergic Agents: May increase anticholinergic effects of Inhaled Anticholinergic Agents. 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
Methacholine: Long-acting muscarinic antagonists (LAMAs) may decrease therapeutic effects of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days 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
Refer to individual monographs.
Refer to individual monographs.
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.
Pulmonary function tests; bone mineral density (at baseline and periodically thereafter); BP, heart rate; serum glucose (diabetic patients); serum potassium; ocular changes (intraocular pressure, cataracts); signs/symptoms of oral or systemic infection; urinary retention; hypercortisolism, or adrenal suppression.
Glycopyrrolate: Competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1 to 3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle, thereby causing bronchodilation.
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.
See individual agents.
