Version July 2025
Note: Utibron Neohaler has been discontinued in the United States for >1 year.
Chronic obstructive pulmonary disease, maintenance: Note: Use combination long-acting bronchodilator (long-acting beta agonist and long-acting muscarinic antagonist) in patients with more symptoms (eg, Group B). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Utibron Neohaler: Dry powder inhaler (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg per capsule): Oral inhalation: Contents of 1 capsule inhaled twice daily.
Ultibro Breezhaler [Canadian product]: Dry powder inhaler (indacaterol 110 mcg/glycopyrrolate 50 mcg per capsule): Oral inhalation: Contents of 1 capsule inhaled once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
ESRD requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
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).
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: Hypertension (2%)
Central nervous system: Headache (≥2%)
Endocrine & metabolic: Hyperglycemia (≥2%)
Gastrointestinal: Diarrhea (≥2%), gastroesophageal reflux disease (≥2%)
Neuromuscular & skeletal: Back pain (2%)
Respiratory: Nasopharyngitis (4%), lower respiratory tract infection (≥2%), pneumonia (≥2%), rhinitis (≥2%), upper respiratory tract infection (≥2%), oropharyngeal pain (2%)
Frequency not defined: Respiratory: Paradoxical bronchospasm
<1%, postmarketing, and/or case reports: Atrial fibrillation, bladder outflow obstruction, chest pain, dizziness, dyspepsia, fatigue, gastroenteritis, hypersensitivity reaction, insomnia, palpitations, peripheral edema, pruritus, skin rash, tachycardia, urinary retention
Hypersensitivity to indacaterol, glycopyrrolate, or any component of the formulation; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma
Canadian labeling: Additional contraindications (not in US labeling): Severe hypersensitivity to milk proteins
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. Indacaterol/glycopyrrolate is not indicated for the treatment of asthma. Available data do not suggest an increased risk of death with use of an LABA in patients with chronic obstructive pulmonary disease (COPD).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.
• CNS effects: May cause drowsiness, dizziness, and/or blurred vision; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity: Immediate hypersensitivity reactions, including angioedema, rash, or urticaria, may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.
• 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.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, arrhythmia, coronary insufficiency, hypertension); beta-agonists may cause elevation in blood pressure and heart rate. Beta-2 agonists may also produce changes in the ECG (eg, T-wave flattening, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may aggravate preexisting diabetes and ketoacidosis and increase serum glucose.
• Glaucoma: Use with caution in patients with narrow angle glaucoma; may increase intraocular pressure.
• 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).
• Renal function impairment: Use with caution in patients with severe renal impairment (GFR <30 mL/minute/1.73 m2) or end-stage renal disease (ESRD) on dialysis; monitor closely.
• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.
• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.
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.
Dosage form specific issues:
• Lactose: Some products may contain lactose; allergic reactions possible in patients with severe milk protein allergy. Use with caution in patients with severe hypersensitivity to milk proteins.
Other warnings:
• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.
Utibron Neohaler has been discontinued in the United States for >1 year.
Yes
Capsules (Utibron Neohaler Inhalation)
27.5-15.6 mcg (per each): $7.34
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.
Capsule, Inhalation:
Ultibro Breezhaler: 110-50 MCG [contains lactose monohydrate]
Oral inhalation: Dry powder inhaler (capsule): For oral inhalation only; do not swallow capsules. Do not remove capsules from blister until immediately before use. Administer at the same time(s) each day. Discard any capsules that are exposed to air and not used immediately. Use the new inhaler device included with each prescription. Refer to product labeling for additional administration instructions.
Chronic obstructive pulmonary disease, maintenance: Long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
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
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
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
Animal reproduction studies have not been conducted with this combination. Beta-agonists have the potential to affect uterine contractility if administered during labor. Refer to individual monographs.
It is not known if indacaterol or glycopyrrolate are present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual monographs.
FEV1, peak flow, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention.
Indacaterol: Relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate; acts locally in the lung.
Glycopyrrolate: In COPD, competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1-3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle thereby causing bronchodilation.
Refer to individual agents
