Version July 2025
Chronic obstructive pulmonary disease, maintenance:
Note: Use long-acting bronchodilator combination therapy (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).
Dry powder inhaler (aclidinium 400 mcg/formoterol 12 mcg per actuation): Oral inhalation: 1 inhalation twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
No dosage adjustment necessary; use caution in severe impairment (an increase in formoterol exposure is likely).
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%:
Central nervous system: Headache (6%), dizziness (1% to <3%), insomnia (1% to <3%)
Gastrointestinal: Xerostomia (1% to <3%)
Genitourinary: Urinary tract infection (1% to <3%)
Infection: Influenza (1% to <3%), tooth abscess (1% to <3%)
Neuromuscular & skeletal: Back pain (4%), arthralgia (1% to <3%), increased creatine phosphokinase in blood specimen (1% to <3%), limb pain (1% to <3%), muscle spasm (1% to <3%), musculoskeletal pain (1% to <3%)
Respiratory: Upper respiratory tract infection (9%), cough (1% to <3%), oropharyngeal pain (1% to <3%), sinusitis (1% to <3%)
Postmarketing: Anaphylaxis, angioedema, bronchospasm, hypersensitivity reaction, pruritus, skin rash, urticaria
Hypersensitivity to aclidinium, formoterol, or any component of the formulation; severe hypersensitivity to milk proteins; use in patients with asthma without an inhaled corticosteroid.
Concerns related to adverse effects:
• Asthma-related deaths: Safety and efficacy of aclidinium/formoterol in patients with asthma have not been established; this combination therapy is not indicated for the treatment of asthma. 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 (Nelson 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).
• Bronchospasm: Rarely, paradoxical bronchospasm 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 headache, dizziness, and/or blurred vision; caution patients about performing tasks which require mental alertness (eg, operating machinery, driving).
• Hypersensitivity reactions: Immediate hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, rash, bronchospasm, or itching, may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.
• Serious effects/fatalities: Do not exceed recommended dose 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 increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (usually transient).
• 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 of inhaled corticosteroids. Consider routine eye exams in chronic users.
• Seizures: Use with caution in patients with seizure disorders; beta-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.
Dosage form specific issues:
• Lactose: May contain lactose; use is contraindicated in patients with severe milk protein allergy.
Other warnings/precautions:
• 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.
One inhalation delivers a dose of aclidinium bromide 396 mcg which is equivalent to aclidinium 340 mcg. Duaklir Pressair inhaler delivers 30 or 60 actuations.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol Powder Breath Activated, Inhalation:
Duaklir Pressair: Aclidinium bromide 400 mcg and formoterol fumarate 12 mcg per actuation (1 ea) [contains lactose]
Duaklir Pressair: Aclidinium bromide 400 mcg and formoterol fumarate 12 mcg per actuation (1 ea [DSC]) [contains lactose, milk protein]
No
Aerosol powder (Duaklir Pressair Inhalation)
400-12 mcg/ACT (per each): $360.00
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 Powder Breath Activated, Inhalation:
Duaklir Genuair: Aclidinium bromide 400 mcg and formoterol fumarate 12 mcg per actuation (1 ea) [contains lactose, milk protein]
Oral inhalation: Dry powder inhaler: Inhaler is breath actuated; administer via oral inhalation once in the morning and evening. Remove inhaler from sealed bag immediately prior to first use. To load dose, remove protective cap and press the orange button all the way down (avoid tilting inhaler). If the control window is green, the inhaler is ready for use; if the control window is red, reactivate inhaler again by pressing and releasing the orange button. Prior to inhaling the dose, exhale fully (do not exhale into the inhaler), then close lips tightly around the inhaler mouthpiece and inhale (rapidly, steadily, and deeply); do not hold the orange button down while inhaling. Keep breathing in even after a "click" is heard to ensure that the full dose has been given. Ensure the dose was delivered correctly by observing the control window change from green to red; if the control window is still green, repeat inhalation steps. When control window has been verified as red, replace the protective cap until next use. Do not wash or put inhaler in water; mouth piece may be cleaned with a dry tissue or cloth. Discard the inhaler when the dose counter displays "0" or within 60 days after removal from sealed bag (whichever occurs first). Refer to product labeling for additional administration instructions.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of chronic obstructive pulmonary disease (COPD).
Limitations of use: Not indicated for relief of acute bronchospasm or for treatment of asthma.
Aclidinium may be confused with clidinium
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: Aclidinium may increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
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
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 Formoterol. Caffeine and Caffeine Containing Products may increase hypokalemic effects of Formoterol. 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
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. Refer to individual monographs.
It is not known if aclidinium or formoterol are present in breast milk following oral inhalation.
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 benefits of treatment to the mother. Refer to individual monographs.
FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; serum glucose, serum potassium; CNS stimulation; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention.
Formoterol relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate. Formoterol has a long-acting effect.
Aclidinium competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.
Refer to individual agents.
