Medically reviewed by Drugs.com. Last updated on Jun 27, 2020.
(in da KA ter ol)
- Indacaterol Maleate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Arcapta Neohaler: 75 mcg [contains lactose monohydrate, milk protein]
Brand Names: U.S.
- Arcapta Neohaler
- Beta2 Agonist
- Beta2-Adrenergic Agonist, Long-Acting
Relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate; acts locally in the lung.
Systemic: Inhalation: 43% to 45% bioavailable
Hepatic; hydroxylated via CYP3A4, CYP2D6, and CYP1A1
Feces (>90%; 54% as unchanged drug [after oral administration]); urine (<2% as unchanged drug)
Onset of Action
5 minutes; Peak effect: 1-4 hours
Time to Peak
Serum: ~15 minutes
Duration of Action
Use: Labeled Indications
Chronic obstructive pulmonary disease (maintenance): Long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Hypersensitivity to indacaterol or any component of the formulation; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.
Chronic obstructive pulmonary disease (maintenance): Dry powder inhaler: Oral inhalation: Contents of 1 capsule (75 mcg) inhaled once daily via approved inhalation device.
Note: Doses of 150 to 300 mcg once daily have been recommended and are used in other countries (Ferguson 2020; GOLD 2018); a possible increase in asthma exacerbations and respiratory-related deaths was noted with the 300 mcg dose; however, no difference in efficacy or adverse events was seen with the 75 and 150 mcg dose (Chowdhury 2011; Ferguson 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Oral inhalation: Dry powder inhaler: Administer via oral inhalation at the same time each day using Neohaler inhaler (US labeling) or Onbrez Breezhaler (Canadian labeling) only. Do not swallow capsules. Use the new inhaler included with each prescription. Do not remove capsule from blister until immediately before use. Place one capsule into inhaler capsule chamber and close until it clicks. Pierce capsule by pressing both red buttons once on sides of device. If powder is left within capsule, repeat inhalation procedure. Do not wash mouthpiece; inhalation device should be kept dry. Discard any capsules that are exposed to air and not used immediately.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Remove capsule from blister pack immediately before use; discard if not used immediately.
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. 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. Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). 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. Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy
Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Indacaterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Indacaterol. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. 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. Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. 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. 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. Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification
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. Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Theophylline Derivatives: May enhance the adverse/toxic effect of Indacaterol. Theophylline Derivatives may enhance the hypokalemic effect of Indacaterol. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Respiratory: Cough (post-inhalation 7% to 24%)
1% to 10%:
Central nervous system: Headache (5%)
Gastrointestinal: Nausea (2%)
Respiratory: Nasopharyngitis (5%), oropharyngeal pain (2%)
<1%, postmarketing, and/or case reports: Dizziness, hypersensitivity reaction, palpitations, paradoxical bronchospasm, pruritus, skin rash, tachycardia
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2-agonist (LABA) is contraindicated in the treatment of asthma. The use of 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 suggest 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 (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current guidelines recommend the use of an as-needed low dose inhaled corticosteroid with formoterol for patients with infrequent symptoms (GINA 2020). Indacaterol is not indicated for the treatment of asthma. Available data do not suggest an increased risk of death with use of LABA in patients with chronic obstructive pulmonary disorder (COPD).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response. Discontinue immediately if paradoxical bronchospasm occurs and institute alternative therapy.
• Hypersensitivity: Immediate hypersensitivity reactions (difficulty in breathing or swallowing; swelling of tongue, lips, and face; urticaria; skin rash) have been reported; discontinue therapy immediately if patient develops an allergic reaction.
• 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.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension); beta-agonists may cause elevation in blood pressure and heart rate. Beta-2-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.
• Appropriate use: Do not use for acute bronchospastic episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Data are not available to determine if LABA use increases the risk of death in patients with COPD. Available data do not suggest an increased risk of death with use of LABA in patients with COPD.
• 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 patients with hyperthyroidism; may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2-agonists may decrease serum potassium (transient).
• Seizures: Use with caution in patients with seizure disorders; beta-2-agonists may result in CNS stimulation/excitation.
• 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: Product may contain lactose; allergic reactions possible in patients with severe milk protein allergy.
• Patient information: Patients using inhaled, short-acting beta-2-agonists should be instructed to discontinue routine use of these medications prior to beginning treatment. Short-acting agents should still be provided to patients; however, use should be reserved for symptomatic relief of acute symptoms. Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of short-acting beta-2-agonists may indicate deterioration of COPD, and medical evaluation must not be delayed.
• Tolerance/tachyphylaxis: Tolerance to the bronchodilator effect, measured by FEV1, has been observed in studies.
FEV1, FVC, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation. Monitor for increased use of short-acting beta2-agonist inhalers; may be marker of a deteriorating condition.
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies. Beta-agonists may interfere with uterine contractility if administered during labor.
What is this drug used for?
• It is used to treat COPD (chronic obstructive pulmonary disease).
• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Sore throat
• Stuffy nose
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat
• Chest pain
• Fast heartbeat
• Abnormal heartbeat
• Severe anxiety
• Passing out
• Vision changes
• Severe headache
• Severe dizziness
• Trouble breathing
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about indacaterol
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- Drug class: adrenergic bronchodilators
Other brands: Arcapta