Indicated for:

Maintenance Treatment of COPD:

• Long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). 

ARCAPTA NEOHALER is not indicated to treat acute deteriorations of COPD.

ARCAPTA NEOHALER is not indicated to treat asthma. The safety and effectiveness of ARCAPTA NEOHALER in asthma have not been established. 

Long-acting beta₂-adrenergic agonists (LABA) increase the risk of asthma-related death.

ARCAPTA NEOHALER is contraindicated with use of a long-acting beta₂-adrenergic agonist (LABA),  without an inhaled corticosteroid, in patients with asthma. 

Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.

ARCAPTA NEOHALER should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. ARCAPTA NEOHALER has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta₂-agonist.

When beginning ARCAPTA NEOHALER, patients who have been taking inhaled, short-acting beta₂ agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing ARCAPTA NEOHALER, the healthcare provider should also prescribe an inhaled, short-acting beta₂-agonist and instruct the patient on how it should be used. Increasing inhaled beta₂-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.

As with other inhaled beta2-adrenergic drugs, ARCAPTA NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

ARCAPTA NEOHALER, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

ARCAPTA NEOHALER, like other beta₂-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, ARCAPTA NEOHALER may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown.

As with other inhaled beta₂-agonists, ARCAPTA NEOHALER may produce paradoxical bronchospasm that may be life-threatening.

Beta₂-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

Clinically notable decreases in serum potassium or changes in blood glucose were infrequent during clinical studies with long-term administration of ARCAPTA NEOHALER with the rates similar to those for placebo controls.

ARCAPTA NEOHALER, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. Doses of the related beta₂-agonist albuterol, when administered intravenously, have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.

ARCAPTA NEOHALER has not been investigated in patients whose diabetes mellitus is not well controlled.

Indacaterol, as with other beta₂-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may have an increased risk of ventricular arrhythmias.

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of ARCAPTA NEOHALER.

The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.

Beta-adrenergic receptor antagonists (beta-blockers) and ARCAPTA NEOHALER may interfere with the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers.

Co-administration of indacaterol 300 mcg (single dose) with verapamil (80 mg t.i.d for 4 days) showed 2-fold increase in indacaterol.

Co-administration of indacaterol inhalation powder 300 mcg (single dose) with erythromycin (400 mg q.i.d for 7 days) showed a 1.4-fold increase in indacaterol.

Co-administration of indacaterol inhalation powder 300 mcg (single dose) with ketoconazole (200 mg b.i.d for 7 days) caused a 1.9-fold increase in indacaterol.

Co-administration of indacaterol 300 mcg (single dose) with ritonavir (300 mg b.i.d for 7.5 days) resulted in a 1.7-fold increase in indacaterol.

If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of ARCAPTA NEOHALER may be potentiated.

There are no adequate and well-controlled studies with ARCAPTA NEOHALER in pregnant women. Animal studies: benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle.

It is not known that the active component of ARCAPTA NEOHALER, indacaterol, is excreted in human milk. Because many drugs are excreted in human milk and because indacaterol has been detected in the milk of lactating rats, caution should be exercised when ARCAPTA NEOHALER is administered to nursing women. 

GoToSource

• Dosage greater than once-daily inhalation of the contents of one 75 mcg ARCAPTA capsule using the NEOHALER inhaler. GoToSource 

• Asthma. GoToSource

• Acute obstructive pulmonary disease. GoToSource 

• Use in patients under the age of 18. GoToSource

Asthma-related deaths. GoToSource

Contact dermatitis. GoToSource

QT interval prolongation. GoToSource

Exacerbation of COPD, nasopharyngitis (swelling of nasal passages and back of throat), headache, upper respiratory tract infection, insomnia (sleep disorder), anxiety, tremor, palpitations (rapid or irregular heartbeat), tachycardia (rapid heart rate) and cardiac arrest. GoToSource

Hyperglycemia (high blood sugar). GoToSource

Constipation. GoToSource

Lawsuits filed for heart attacks and strokes.