Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per cap Indacaterol maleate 110 mcg, glycopyrronium bromide 50 mcg. Each delivered dose (via mouthpiece of the inhaler): Indacaterol maleate 85 mcg, glycopyrronium bromide 43 mcg
Indications/Uses
Once-daily maintenance bronchodilator treatment to relieve symptoms & reduce exacerbations in adults w/ COPD.
Dosage/Direction for Use
Special Precautions
Not to be administered w/ other long-acting β-agonists or long-acting muscarinic-antagonists. Not to be used in asthma. Not for acute use; do not use as rescue therapy. Discontinue immediately & institute alternative therapy if hypersensitivity & paradoxical bronchospasm occurs. Narrow-angle glaucoma & urinary retention. CV disorders (CAD, acute MI, cardiac arrhythmias, HTN); convulsive disorders or thyrotoxicosis; in patients who are unusually responsive to β2-adrenergic agonists. Clinically significant CV effect as measured by increases in pulse rate, BP, &/or symptoms, ECG changes. Significant hypokalemia in some patients, which has the potential to produce adverse CV effects. Hypokalemia may be potentiated by hypoxia & concomitant treatment which may increase susceptibility to cardiac arrhythmias in patients w/ severe COPD. Hyperglycemia. Closely monitor plasma glucose in diabetic patients. Severe hepatic & renal impairment or end-stage renal disease requiring dialysis. May inhibit labor due to relaxant effect on uterine smooth muscle. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Upper resp tract infection. Nasopharyngitis, UTI, sinusitis, rhinitis; hypersensitivity; hyperglycemia & DM; dizziness, headache; cough, oropharyngeal pain including throat irritation; dyspepsia, dental caries; bladder obstruction & urinary retention; pyrexia, chest pain.
Drug Interactions
Indacaterol: May weaken or antagonize the effect w/ β-adrenergic blockers. Potentiated QT interval w/ MAOIs, TCAs or drugs known to prolong QT interval. May potentiate undesirable effects w/ other sympathomimetic agents (alone or as part of combination therapy). May potentiate possible hypokalemic effect w/ methylxanthine derivatives, steroids, or non-K-sparing diuretics. Glycopyrronium: Not recommended w/ co-administration of inhaled anticholinergic-containing drugs.
ATC Classification
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.
Presentation/Packing
Form
Ultibro Breezhaler inhalation powd cap
Packing/Price
(+ inhaler) 30's; (+ inhaler) 6's
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