Arcapta

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Arcapta

Property Description
Active Ingredient Indacaterol maleate
Form Inhalation powder (capsule for inhalation)
Pharmacological Class Long-Acting Beta2-Adrenergic Agonist (LABA)
Route of Administration Oral inhalation
Origin Synthetic compound

Arcapta: Definition and Pharmacological Classification

Arcapta is a prescription-only medicine containing the active ingredient indacaterol maleate, a synthetic compound derived from monohydroxyquinoline. It is formally classified as an ultra-long-acting member of the Long-Acting Beta2-Adrenergic Agonist (LABA) pharmacological class. This classification dictates the medicine's central function: acting as an adrenergic bronchodilator to stimulate specific receptors in the airways, thereby promoting muscle relaxation and widening the air passages.

The medication possesses a dual property of rapid onset combined with an extended duration of action, providing a full 24 hours of sustained effect. This sustained therapeutic profile is a key feature that distinguishes it from older, shorter-acting treatments used for acute relief.

Composition, Form, and General Therapeutic Purpose

The medicine is supplied as a dry powder formulation contained within a small capsule, which is intended solely for administration via oral inhalation using a specific device; the capsule must not be swallowed. As a single-ingredient product, its composition includes indacaterol maleate and an inactive carrier, typically lactose monohydrate, which ensures the powder is delivered efficiently into the lungs.

Its core purpose is to provide long-term maintenance treatment by functioning as a 24-hour bronchodilator, helping patients manage chronic airflow obstruction with a single daily dose. The medication is a component in treatment plans for adults requiring consistent, baseline relief from chronic respiratory tightness and difficulty breathing.

What side effects are possible with Arcapta?

Possible Side Effects and Safety Information

The safety profile for Arcapta (indacaterol maleate) is formally classified by regulatory authorities based on clinical trial data, detailing the frequency and system-organ class affected by adverse reactions. The medicine, as a Long-Acting Beta2-Adrenergic Agonist (LABA), is associated with specific class-related safety constraints.


Official Adverse Reactions and Frequencies

Adverse reactions are formally grouped into categories based on frequency:

  • Very Common (geq1/10): Upper respiratory tract infection.
  • Common (geq1/100 to <1/10): Nasopharyngitis, Headache, Cough, Nausea, and Oropharyngeal pain (including throat irritation).
  • Uncommon (geq1/1,000 to <1/100): Ischaemic heart disease, Palpitations, Tachycardia, and Hypersensitivity reactions.

Serious Safety Restrictions

Official labeling emphasizes serious risks, particularly those related to the LABA pharmacological class:

  • Paradoxical Bronchospasm: Inhalation may result in a sudden, severe worsening of breathing, which is noted as potentially life-threatening.
  • Asthma-Related Events: Arcapta is not indicated for asthma and carries a regulatory warning regarding the increased risk of serious asthma-related events when any LABA is used alone.

Population-Specific Cautions

Caution is advised in individuals with certain coexisting conditions. This includes patients with pre-existing cardiovascular disorders (e.g., coronary insufficiency, arrhythmias, hypertension), and those with metabolic disorders such as diabetes mellitus or thyrotoxicosis, due to the potential for clinically significant systemic effects. The medication is also not for co-administration with other LABA-containing products.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Arcapta

Property Description (Strictly Label-Based)
Documented Overdose Presentations Overdosage is defined by the exaggerated effects of beta-adrenergic stimulation, which include severe tachycardia (heart rate increases up to 200 beats per minute), cardiac arrhythmias, angina, and systemic signs such as tremor, nervousness, nausea, and headache.
Physiological Systems Affected The cardiovascular system is primarily affected, with risk of life-threatening events. The metabolic system may exhibit significant changes, specifically hypokalemia (low potassium) and hyperglycemia (high blood sugar).
Dose-Related Factors Overdose manifestations are associated with the consequences of excessive use of the inhaled sympathomimetic drug, or use in conjunction with other Long-Acting Beta2-Adrenergic Agonists (LABA).
Emergency-Response Statements Immediate medical attention must be sought if an overdose is suspected. Call the national Poison Help line or emergency services if the affected person has collapsed, is having trouble breathing, or cannot be awakened.

Official Overdose Statements:

  • Overdose can lead to severe cardiovascular events, including cardiac arrest and death, reported in association with excessive use of inhaled sympathomimetic agents.
  • A potentially life-threatening event is the occurrence of paradoxical bronchospasm, which requires immediate drug discontinuation.
  • Management is defined as symptomatic and supportive treatment in a monitored setting.

Connection to the Overall Overdose Profile (2–4 sentences): Regulatory documents define the overdose profile of indacaterol maleate based on the known, potentially severe physiological consequences of excessive beta-adrenergic exposure. This profile necessitates that individuals exhibiting signs of overdose seek immediate medical attention or call emergency services, as mandated by government labeling, due to the documented risk of severe cardiovascular and respiratory complications. The officially described management approach is confined to symptomatic and supportive care in a medical setting, as no specific antidote is listed in the official labeling.

Therapeutic Uses of Arcapta

Arcapta: Main Uses and Benefits

Quick Facts

  • Primary Use: Long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD).
  • Conditions Treated: Symptoms associated with chronic bronchitis and emphysema.
  • Benefit: Provides once-daily bronchodilation to improve breathing.

Arcapta (indacaterol inhalation powder) is a medication utilized for the long-term maintenance treatment of airflow obstruction in adult patients diagnosed with chronic obstructive pulmonary disease (COPD). COPD is a progressive condition that includes chronic bronchitis and emphysema.

The primary therapeutic benefit is to act as a bronchodilator, helping the muscles around the airways in the lungs to stay relaxed. This action assists in managing symptoms such as wheezing, coughing, chest tightness, and shortness of breath by improving airflow.

Arcapta is used once daily to provide consistent, sustained improvement in lung function over 24 hours. It is not indicated to treat acute deteriorations of COPD and should not be used as a rescue medicine for sudden breathing problems.

Eligibility and Restrictions for Use

Use of Arcapta (indacaterol) is established solely for adult patients (18 years and older) for the long-term maintenance treatment of airflow obstruction in Chronic Obstructive Pulmonary Disease (COPD). No dosage adjustments are typically required for older adults or those with renal or mild to moderate hepatic impairment, based on official regulatory findings.

The medicine is contraindicated in patients with a history of hypersensitivity to indacaterol or any excipient. It is also absolutely contraindicated for use as monotherapy in patients with asthma, a critical class-wide restriction. Arcapta is not indicated for the relief of acute COPD symptoms or for use in patients with acutely deteriorating disease.

Use is not established in the pediatric population (under 18). Regulators advise caution when the medicine is used by patients with certain existing comorbidities, such as cardiovascular disorders, convulsive disorders, or thyrotoxicosis. During pregnancy and lactation, use is restricted and requires a risk-benefit assessment, as the drug's safety status is categorized based on limited available data.

What should I know about interactions with other medicines?

Arcapta Interactions with other medicines and products

The regulatory profile for Arcapta (indacaterol) outlines specific pharmacokinetic and pharmacodynamic interactions. Combining Arcapta with other Long-Acting Beta2-Adrenergic Agonists (LABAs) is formally prohibited by regulatory authorities due to the documented risk of severe, additive cardiovascular effects and potential for overdose. This is classified as a formal restriction.

Pharmacokinetic Interactions involve metabolic pathways. Indacaterol is metabolized by the CYP3A4 and UGT1A1 enzymes and is a substrate for the P-glycoprotein (P-gp) efflux transporter. Co-administration with strong dual inhibitors of CYP3A4 and P-gp, such as ketoconazole or ritonavir, is officially documented to increase the systemic exposure (AUC and Cmax) of indacaterol.

Pharmacodynamic Interactions define how Arcapta may reinforce or be inhibited by other drug classes. Adrenergic drugs, Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs), and agents that prolong the QTc interval may potentiate Arcapta’s effects on the cardiovascular system. The co-administration of Xanthine Derivatives, steroids, or non-potassium sparing diuretics may increase the official risk of hypokalemia or ECG changes. Conversely, beta-blockers may cause pharmacodynamic antagonism, resulting in a reduction of indacaprol’s intended effect. No mandatory timing separation rules are specified in the official labeling, and no specific outcome-based interactions with food, alcohol, or herbal products are formally documented.

Mechanism of Action

How Arcapta Works

Arcapta (indacaterol) functions as a long-acting beta-2 adrenergic receptor agonist (LABA). Following inhalation, the drug substance localizes to the airway smooth muscle, where it selectively binds to the beta2-adrenoreceptors. This interaction activates the stimulatory G-protein (Gs), which in turn stimulates the enzyme adenyl cyclase.

The activation of adenyl cyclase catalyzes the conversion of intracellular adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). The resulting increase in intracellular cAMP levels leads to the activation of protein kinase A (PKA). PKA mediates the phosphorylation of various target proteins, ultimately causing the relaxation of bronchial smooth muscle cells.

This cellular cascade results in a system-level physiological consequence of bronchodilation, which is the widening of the airways. The physicochemical properties of indacaterol, including its high lipophilicity, contribute to its extended duration of action by ensuring the compound remains associated with the lipophilic domains of the airway cell membranes for prolonged periods.

Dosage and Administration Information

Arcapta is a dry powder medication administered exclusively via the oral inhalation route using the designated NEOHALER inhaler. The capsule containing the powder must not be swallowed, as the medicine's full effect is only achieved when inhaled into the lungs. The treatment is designated strictly for long-term maintenance and must not be used for sudden or acute breathing problems.

Official Administration Guidelines

Feature Administration Guideline
Dosing Schedule Once-daily inhalation of the contents of one 75 microgram (mcg) capsule.
Frequency Rule Administer once daily every day, preferably at the same time; do not exceed one dose per 24 hours.
Preparation Capsule must be kept in the blister and only removed immediately before use.
Missed Dose Take the dose as soon as it is remembered, but maintain the rule of no more than one dose in 24 hours.

Specific Use Considerations

No dosage adjustment is required for older adults (geriatric patients), nor for those with mild to moderate hepatic (liver) or renal (kidney) impairment. Use of the medicine is not recommended for children. These instructions define a consistent, procedural protocol for delivering the long-acting bronchodilator as intended for foundational respiratory support.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Arcapta


Research Foundation for COPD Airflow Obstruction

The core evidence for Arcapta (indacaterol) was evaluated in research exploring the long-term management of airflow obstruction in adults with Chronic Obstructive Pulmonary Disease (COPD). This research foundation is built around large, multinational Randomized Controlled Trials (RCTs). The studies were designed to observe patterns over periods typically ranging from 12 weeks to one year.

The main outcomes related to systemic or functional imbalance that researchers monitored included objective measurements of lung function, such as the forced expiratory volume in one second ( FEV1). This measurement was used in research exploring how symptoms change over time and to characterize the measurements observed over a full 24-hour interval. Researchers also tracked outcomes related to physical discomfort like breathlessness (dyspnea) and general health status.

Key Outcomes Examined in Clinical Trials

The research examined whether FEV1 measurements data show patterns related to the FEV1 measurements 24 hours after a dose when compared to inactive treatment. Findings describe patterns observed in the studies across different research settings. Research also examined the observed measurements of rescue medication use (e.g., a short-acting inhaler) during the study period.


Comparative Studies and Placebo Evidence

The research landscape includes studies that compared measurements not only against placebo but also against other common long-acting bronchodilators, such as tiotropium and twice-daily LABAs like salmeterol. Findings data show patterns related to measurements of lung function when compared against other once-daily bronchodilators. In comparisons against twice-daily LABAs, research describes patterns that were observed across different lung function measurements during the study period. These results apply only to the populations studied and study results reflect the specific conditions under which they were conducted.


Recognized Evidence Gaps and Areas of Uncertainty

Although the evidence derived from Randomized Controlled Trials for indacaterol is extensive, several areas of uncertainty remain. Long-term effects are not fully established beyond the one-year follow-up period in primary trials. Findings were mixed regarding the consistency of certain patient-reported outcomes describing perceived discomfort, such as cough or phlegm. This suggests that variability exists regarding these specific symptoms in the observed populations. Finally, research provides context but not individual predictions for patients whose clinical profile falls outside the typical trial parameters.

Frequently Asked Questions (FAQ)

Common questions about Arcapta (FAQ)


Q: Is Arcapta the same kind of medicine as a rescue inhaler?

A: Arcapta is officially classified as a maintenance treatment for chronic obstructive pulmonary disease (COPD). It is not indicated for the relief of sudden or acute breathing problems. When quick relief is needed for acute symptoms, an individual must use a short-acting beta2-agonist, which is commonly known as a rescue inhaler.


Q: How quickly can I expect Arcapta to start working after I use it?

A: Official product information, based on clinical studies, describes Arcapta as having a rapid onset of action. Bronchodilation, which is the widening of the airways, has been observed to typically occur within 5 minutes after a dose is administered.


Q: What is the difference between Arcapta and other inhaled maintenance drugs for COPD?

A: Arcapta is classified as an ultra-long-acting beta2-adrenergic agonist (LABA). This classification means it is designed to provide sustained bronchodilation for a full 24 hours with a single daily dose. This distinguishes its dosing frequency from some older maintenance treatments that may require administration twice a day.


Q: What kind of studies have been done on Arcapta?

A: The core evidence for Arcapta is based on large, multinational Randomized Controlled Trials (RCTs). These studies primarily evaluated objective measurements of lung function, such as the forced expiratory volume in one second (FEV1), as well as patient-reported symptoms and overall health status in adults with COPD over periods of up to one year.


Q: Is there a generic version of Arcapta available?

A: Arcapta (indacaterol maleate) is the brand name product. The current availability status of any generic versions is maintained by regulatory bodies such as the FDA and may change over time.


Q: Does Arcapta cause weight gain or loss?

A: Weight changes were generally not reported among the most common adverse reactions in the main clinical trials. However, some official sources list unusual weight loss or rapid weight gain in the categories of less common or rare effects observed.


Q: Are there any foods or drinks I need to avoid while using Arcapta?

A: Official regulatory information does not formally document any specific outcome-based interactions between Arcapta and common foods, drinks, or alcohol. Patients are generally advised to discuss all aspects of their diet and medication regimen with a healthcare provider.


Q: Can using Arcapta affect my sleep?

A: While common side effects do not typically include sleep disturbances, an effect such as insomnia has been reported in clinical trials. Any changes or difficulties with sleep should be discussed with a healthcare provider.


Q: Why is Arcapta only approved for COPD and not asthma?

A: Arcapta belongs to the Long-Acting Beta2-Adrenergic Agonist (LABA) class. Regulatory authorities note that using medicines from this class alone (monotherapy) in patients with asthma has been associated with an increased risk of serious asthma-related events. Therefore, Arcapta is strictly not indicated for the treatment of asthma.


Q: Will Arcapta interact with medicines for depression or anxiety?

A: Official regulatory documents indicate that co-administration with certain drugs used for depression, such as Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs), may potentiate Arcapta's effects on the heart and blood vessels. Official guidance notes the importance of informing a healthcare provider of all current medications before starting Arcapta.


Q: Is it normal to feel a fast heartbeat when I first start taking Arcapta?

A: As a class effect of Long-Acting Beta2-Agonists, Arcapta may cause heart-related effects such as tachycardia (fast heartbeat) and palpitations. These are listed as uncommon adverse reactions in clinical trials. Regulatory labeling suggests heart-related symptoms should be discussed with a healthcare professional.


Q: Does Arcapta interact with common pain relievers like Tylenol or Advil?

A: Official labeling primarily details interactions with specific drug classes, such as certain cardiovascular or psychological medications. No specific warnings or outcome-based restrictions involving common over-the-counter pain relievers like acetaminophen (Tylenol) or ibuprofen (Advil) are formally documented.


Q: Are there any documented long-term effects of using Arcapta?

A: Clinical trials provided data on effects over periods typically ranging from 12 weeks to one year. Official regulatory information notes that the long-term effects are not fully established beyond the one-year follow-up period studied in the primary research trials.


Q: Are there any specific heart conditions that prevent the use of Arcapta?

A: There are no absolute contraindications (preventions) based on specific heart conditions. However, caution is advised in individuals with pre-existing cardiovascular disorders, such as coronary insufficiency, heart arrhythmias, or high blood pressure, due to the potential for systemic effects.


Q: Can Arcapta be used with a spacer device?

A: Arcapta is a dry powder formulation and is designed to be administered exclusively using the designated NEOHALER inhaler device. Spacer devices are typically used only with other types of inhalers, such as pressurized Metered-Dose Inhalers (MDIs).


Q: Does Arcapta cause anxiety or nervousness?

A: The official list of common side effects does not include anxiety. However, the regulatory labeling does advise caution and monitoring for central nervous system stimulation, which may include symptoms such as nervousness or tremor.


Q: Can using Arcapta cause muscle cramps or spasms?

A: Yes, muscle spasms and musculoskeletal pain are listed as common adverse reactions that were observed in the clinical trial data for Arcapta.


Q: Does Arcapta have a strong taste or smell?

A: While not a common adverse reaction, official documents sometimes note that some long-acting bronchodilators may cause taste disturbance (dysgeusia). Any unusual or strong taste experienced should be discussed with a healthcare provider.


Q: Are there any restrictions on driving or operating machinery while using Arcapta?

A: Official European regulatory documents indicate that, based on the known safety profile, Arcapta is unlikely to affect the ability to drive or operate machines. However, official documents suggest that if effects like dizziness or vision changes are experienced, these activities should be approached with caution.


Q: Can I stop using Arcapta if my COPD symptoms improve?

A: Arcapta is intended for long-term maintenance treatment of COPD. Regulatory information cautions that the abrupt discontinuation of maintenance therapy can potentially lead to a worsening of the underlying chronic condition.


Q: What are the most common reasons people stop taking Arcapta in studies?

A: Official clinical trial data show that the most common reasons participants discontinued using Arcapta were due to the worsening of their COPD (an exacerbation) or due to common adverse events, such as cough.


Q: Is Arcapta considered a 'new' or 'older' medication for COPD?

A: Arcapta (indacaterol) was first approved by the FDA in 2011. Its active ingredient is classified as an ultra-long-acting bronchodilator, representing a later development in the class of Long-Acting Beta2-Agonists.


Q: What if Arcapta doesn't seem to be helping my breathing after a few weeks?

A: If symptoms worsen, or if the drug is no longer controlling symptoms, regulatory labeling indicates this may be a marker of disease deterioration. In this situation, the patient's treatment regimen requires re-evaluation by a healthcare professional at once.


Q: Is Arcapta safe to use with an inhaled corticosteroid?

A: The use of Arcapta with inhaled corticosteroids (ICS) is common in clinical practice. Official documents caution that the co-administration of steroids may increase the risk of certain side effects, such as a drop in blood potassium (hypokalemia), but this is a general warning, not a contraindication.


Q: What population groups were excluded from the main research trials for Arcapta?

A: Research trials often excluded populations whose conditions could complicate the assessment of the drug or increase their risk. This includes patients with certain severe cardiovascular conditions, significant unstable liver or kidney disease, or any history of asthma.

How should Arcapta be stored and disposed of?

How to Store and Dispose of ARCAPTA NEOHALER

Storage Conditions

ARCAPTA NEOHALER (indacaterol inhalation powder) must be kept at controlled room temperature, specifically 25 C (77 F), with permitted fluctuations between 15 C and 30 C (59 F and 86 F). The product must be protected from both moisture and light.

Handling and Packaging

The capsules must remain in their original blister packaging until the moment of use. It is strictly required not to store the capsules inside the NEOHALER inhaler device. Keep ARCAPTA NEOHALER, like all medicines, out of the reach of children.

Disposal Instructions

The empty capsule must be discarded immediately after a dose is taken. For any unused or expired medicine, consult a healthcare professional or pharmacist regarding proper disposal methods.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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