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It is long-acting betaR 2R- higher than placebo) are nasopharyngitis and hypertension. (3T6.13T) adrenergic agonist (LABA), and glycopyrrolate, an anticholinergic, indicated To report SUSPECTED ADVERSE REACTIONS, contact Sunovion for the long-term, maintenance treatment of airflow obstruction in patients Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or with chronic obstructive pulmonary disease (COPD).
Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. It is also long acting due to its high affinity to the lipid raft domains in the airway membrane so it slowly dissociates from the receptors. Indacaterol also has a high intrinsic efficacy so it is also very rapid acting - onset of action occurs within 5 minutes.
The pharmacological effects of beta2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic monophosphate). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that indacaterol has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3-receptors. This selectivity profile is similar to formoterol. The clinical significance of these findings is unknown.
Maintenance therapy in chronic obstructive pulmonary disease
Adult: Available preparations:
Indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg per inhalation cap
1 cap bid via inhaler device.
Indacaterol 85 mcg and glycopyrrolate 54 mcg per inhalation cap
1 cap once daily via inhaler device.
ndacaterol: May potentiate hypokalaemic effect with xanthine derivatives, steroids, diuretics. May potentiate CV effects with MAOIs, TCA, QTc-prolonging agents. May cause sever bronchospasm with β-blockers.
Glycopyrronium: Increased adverse effects with other anticholinergic drugs.
Monotherapy for the treatment of asthma, acute bronchospasm, acute episodes of COPD.
Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.
There is a limited amount of data from the use of Indacaterol and Glycopyrronium combination in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Lactation: Indacaterol and Glycopyrronium combination should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. High doses of Glycopyrronium may lead to anticholinergic signs and symptoms.
Indacaterol 27.5 µg & Glycopyrronium 15.6 µg