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ARCAPTA NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients.
Use of a LABA, including ARCAPTA NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma.
Use of a LABA, including ARCAPTA NEOHALER, as monotherapy (without inhaled corticosteroids) for asthma, increases the risk of serious asthma-related events including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with ARCAPTA NEOHALER has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.
ARCAPTA NEOHALER should not be initiated in patients with acutely deteriorating COPD or potentially life-threatening episodes of COPD, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
ARCAPTA NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ARCAPTA NEOHALER should not use another medicine containing a LABA for any reason.
Immediate hypersensitivity reactions may occur with ARCAPTA NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. ARCAPTA NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.
As with other inhaled beta2-adrenergic agonists, ARCAPTA NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, ARCAPTA NEOHALER should be discontinued immediately and alternative therapy instituted.
ARCAPTA NEOHALER, like with other beta2-adrenergic 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. ARCAPTA NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.
As with other beta2-adrenergic agonists, ARCAPTA NEOHALER should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.
As with other beta2-adrenergic agonists, ARCAPTA NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.
ARCAPTA NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
In 6 clinical trials, 48% of ARCAPTA NEOHALER patients reported adverse reactions compared with 43% of placebo patients. The most common adverse events reported in ≥2% of patients taking ARCAPTA NEOHALER, and occurring more frequently than in patients taking placebo, were cough (6.5% vs 4.5%), nasopharyngitis (5.3% vs 2.7%), headache (5.1% vs 2.5%), nausea (2.4% vs 0.9%), and oropharyngeal pain (2.2% vs 0.7%).
The most common serious adverse reactions were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups.
ARCAPTA capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules are only for oral inhalation and should only be used with the NEOHALER device.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
ARCAPTA® NEOHALER® (indacaterol) Inhalation Powder is a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important limitations: ARCAPTA NEOHALER is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.