Ultibro Breezhaler

Per cap Indacaterol 110 mcg, glycopyrronium 50 mcg. Each delivered dose (via mouthpiece of the inhaler): Indacaterol 85 mcg, glycopyrronium 43 mcg

Maintenance bronchodilator treatment to relieve symptoms in patients w/ COPD. Reduction of exacerbations of COPD in patients w/ a history of exacerbations.

Inhalation 1 cap once daily using the provided inhaler, administered at the same time of the day each day.

Hypersensitivity. Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Not for the treatment of asthma &/or acute episodes of bronchospasm. Discontinue immediately if hypersensitivity &/or paradoxical bronchospasm occurs. Use w/ caution in patients w/ narrow-angle glaucoma or urinary retention; CV disorders (CAD, acute MI, cardiac arrhythmias, HTN); known or suspected QT interval prolongation or patients treated w/ medicinal products affecting the QT interval; unstable ischaemic heart disease, left ventricular failure, history of MI, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or w/ prolonged QTc (>450 ms); convulsive disorders or thyrotoxicosis; unusually responsive to β₂-adrenergic agonists. May produce significant hypokalaemia. Inhalation of high doses may produce increases in plasma glucose. Closely monitor plasma glucose in diabetic patients upon treatment initiation. Be alert for signs & symptoms of prostatic hyperplasia or bladder-neck obstruction (eg, difficulty passing urine, painful urination). Do not administer concomitantly w/ other long-acting β-adrenergic agonists or muscarinic antagonists. Patients w/ severe renal impairment or ESRD requiring dialysis; severe hepatic impairment. Pregnancy & lactation. May inhibit labor due to a relaxant effect on uterine smooth muscle. Do not use in childn <18 yr.

URTI. Nasopharyngitis, UTI, sinusitis, rhinitis; hypersensitivity; hyperglycaemia & DM; dizziness, headache; cough, oropharyngeal pain including throat irritation; dyspepsia, dental caries; bladder obstruction & urinary retention; pyrexia, chest pain.

Indacaterol: Weakened or antagonized effect w/ β-adrenergic blockers. Potentiated effects on QT interval w/ MAOIs, TCAs, or drugs known to prolong the QT interval. Potentiated adverse effects w/ other sympathomimetic agents. Potentiated possible hypokalaemic effect w/ methylxanthine derivatives, steroids, or non-K-sparing diuretics. Glycopyrronium: Co-administration w/ inhaled anticholinergics is not recommended.

Antiasthmatic & COPD Preparations

R03AL04 - indacaterol and glycopyrronium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.

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