Adult Dosing
Maintenance treatment of COPD
- 75 mcg capsule qd by oral inhalation with Neohaler device
- Administer once daily at the same time of the day; if a dose is missed, take the next dose as soon as it is remembered
Notes:- Do not swallow the capsule
- Do not administer more than once daily every day
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Immediate hypersensitivity reactions have been reported with therapy. If allergic reactions such as swelling of tongue, lips and face, urticaria and difficulties in breathing or swallowing occurs discontinue the therapy and seek alternative therapy
- A large placebo-controlled study in asthma patients receiving long-acting beta2-adrenergic agonists (LABA) showed an increased risk of asthma-related deaths. However, no data available to determine whether the rate of death in patients with COPD is increased by LABA
- Safety and efficacy of indacaterol in patients with asthma have not been established and is not indicated for the treatment of asthma [US Black Box Warning]
- Therapy should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. Also, indacaterol should not be used for the relief of acute symptoms, such as for the treatment of acute episodes of bronchospasm. Treat acute symptoms with an inhaled short-acting beta2-agonist
- Significant cardiovascular adverse effects and fatalities may occur with excessive use of inhaled sympathomimetic drugs. Hence, do not use inhaled beta2-adrenergic drugs at higher doses than recommended or in conjunction with other agents containing long-acting beta2-agonists, as it may lead to overdosage
- Therapy may produce paradoxical bronchospasm that may be life-threatening. Discontinue the drug immediately if paradoxical bronchospasm occurs and initiate alternative therapy
- Indacaterol may produce a clinically significant cardiovascular effect as manifested by increases in pulse rate, systolic or diastolic blood pressure, or symptoms; discontinue therapy if such effects occur
- ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression have been associated with beta-agonists; therefore, use therapy cautiously in patients with cardiovascular disorders, especially cardiac arrhythmias, coronary insufficiency, and hypertension
- Significant hypokalemia, which has the potential to produce adverse cardiovascular effects, has been reported with beta2-agonists. However, this hypokalemia is usually transient and does not require any supplementation
- Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose
Cautions: Use cautiously in
- Concomitant use with beta-blockers
- Concomitant use with other beta-agonists
- Diabetes mellitus
- Convulsive disorders
- Thyrotoxicosis
- Hypokalemia
Supplemental Patient Information
- Advise patients to promptly notify their physician if they experience worsening of symptoms, significant decrease in lung function, decreasing effectiveness of short-acting beta2-agnosits, or need for more inhalations than usual of inhaled, short-acting beta2-agonists
- Instruct patients not to use more than the recommended once daily dose of indacaterol
Pregnancy Category:C
Breastfeeding: Safety unknown. It is not known whether indacaterol is excreted in human milk. Manufacturer advises caution.
