Ultibro110 mcg+50 mcg

Indacaterol & Glycopyrronium combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Combined bronchodilators

Glycopyrronium: Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine's effect on muscarinic receptors in the airway smooth muscleIndacaterol: Long-acting β2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

Indacaterol 110 µg and Glycopyrronium 50 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule once daily with the ConviHaler device.Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.

For inhalation use only. The capsules must not be swallowed.

Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs, beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact with Indacaterol.

Hypersensitivity to indacaterol, glycopyrronium or to any of the excipients of Indacaterol & Glycopyrronium. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication Indacaterol or glycopyrrolate is not indicated for the treatment of asthma Use in children: This should not be used in patients <18 years.

Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Indacaterol and Glycopyrronium combination is as a twice daily maintenance bronchodilator should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Indacaterol and Glycopyrronium combination inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.

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.

Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.

Renal Impairment: This can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk.Hepatic Impairment: This can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of Ultibro 110 mcg+50 mcg Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients.Elderly: Indacaterol & Glycopyrronium Breezhaler can be used at the recommended dose in elderly patients

Combined bronchodilators

Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8 hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56 and its empirical formula is C24H28N2O3.C4H4O4. Indacaterol Maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in N methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol. Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.

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. 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.