Indacaterol Maleate

Indacaterol Maleate is a long-acting β2-adrenergic agonist used for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD. It acts locally in the lung as a bronchodilator and stimulates intracellular adenyl cyclase to relax bronchial smooth muscle. It is not approved for the treatment of asthma.

• Long-term maintenance bronchodilator treatment of airflow obstruction in COPD patients (including chronic bronchitis and/or emphysema)

Adult Dose (Inhalation):

• Recommended dose: Inhale contents of one 75 mcg, 150 mcg, or 300 mcg capsule once daily using device
• Max: 300 mcg once daily
• Do not swallow capsules

Geriatric: No dosage adjustment required

Renal Impairment: No dosage adjustment required

Hepatic Impairment: Mild-moderate: No adjustment; severe: No data available

Child Dose: Safety and efficacy not established

Most Common:

• Cough
• Nasopharyngitis
• Headache
• Nausea
• Oropharyngeal pain
• Runny nose
• Dizziness

Others: Hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritus

Precautions:

• LABA monotherapy increases risk of serious asthma-related events
• Not approved for asthma; do not use in asthma patients (without long-term control medication)
• Do not use to treat acute symptoms
• If paradoxical bronchospasm occurs, discontinue
• Caution in cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes mellitus
• Caution with MAO inhibitors, tricyclic antidepressants or drugs that prolong QT interval

Contraindications:

• Hypersensitivity to Indacaterol or any ingredients
• All LABA contraindicated in asthma without long-term asthma control medication

Drug Interactions:

• Potentiated adverse effects with other sympathomimetic agents
• Methylxanthine derivatives, steroids or non-potassium-sparing diuretics may potentiate hypokalemic effect
• Beta-blockers may interfere with effect of Indacaterol

Food Interactions: It is unsafe to consume alcohol with Indacaterol Maleate.

Use in Pregnancy: Category C; no adequate and well-controlled studies; use only if potential benefit justifies potential risk to fetus.

Use in Lactation: It is not known whether Indacaterol is excreted in human milk; detected in milk of lactating rats; caution should be exercised.

Renal Impairment: No dosage adjustment required.

Hepatic Impairment: Mild-moderate: No dosage adjustment; severe: No data available.

Overdose: May cause angina, hypertension or hypotension, tachycardia (up to 200 bpm), arrhythmias, nervousness, headache, tremor, dry mouth, palpitations, muscle cramps, nausea, dizziness, fatigue, hypokalemia, hyperglycemia, metabolic acidosis, insomnia; cardiac arrest and death may occur.