Indacaterol

Indications

Indacaterol is used for: Indacaterol Maleate is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with, chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Adult Dose

Inhalation Maintenance therapy in chronic obstructive pulmonary disease Adult: As inhal cap: Inhale 75-150 mcg once daily using inhaler. Max: 300 mcg once daily. Hepatic impairment No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment No dose adjustment is required for patients with renal impairment.

Administration

Contra Indications

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients.

Precautions

Not intended for treatment of asthma and acute deterioration of COPD. Patient w/ acutely deteriorating COPD, thyrotoxicosis, seizure disorders, DM, hypokalaemia, CV disorders esp coronary insufficiency, cardiac arrhythmias or HTN. Pregnancy and lactation. Lactation: Unknown whether distributed in human breast milk; use caution

Pregnancy-Lactation

Pregnancy Category: C Beta-agonists are known to inhibit uterine contractility Lactation: Unknown whether distributed in human breast milk; use caution

Interactions

Potentiated adverse effects w/ other sympathomimetic agents; possible hypokalaemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists. Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp.

Adverse Effects

Side effects of Indacaterol : >10% Post-inhalation cough (24% compared with 7% on placebo) 1-10% Cough (6.5%), Nasopharyngitis (5.3%), Headache (5.1%), Nausea (2.4%), Oropharyngeal pain (2.2%) Potentially Fatal: Asthma-related deaths.

Mechanism of Action

Indacaterol is a long acting β2-adrenergic agonist. It relaxes the bronchial smooth muscle by selective action on β2-receptor which acts locally in the lungs and w/ little effect on heart rate.