Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium




Concise Prescribing Info
Indacaterol 110 mcg, glycopyrronium Br 50 mcg
Once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients w/ COPD.
Dosage/Direction for Use
Special Precautions
Discontinue use if hypersensitivity reactions & paradoxical bronchospasm occurs. Not to be used for asthma & acute bronchospasm episodes. Narrow-angle glaucoma; urinary retention; CV disorders (eg, CAD, acute MI, cardiac arrhythmias, HTN); known or suspected QT interval prolongation or patients treated w/ medicinal products affecting QT interval; unstable ischaemic heart diseases, left ventricular failure; hypokalemia; hyperglycemia; convulsive disorders or thyrotoxicosis, patients unusually responsive to β2-adrenergic agonists. Not to be used concomitantly w/ long-acting β-adrenergic agonists & muscarinic antagonists. Not to be used in galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe hepatic & renal impairment; ESRD requiring dialysis. Pregnancy & lactation. Paed <18 yr.
Adverse Reactions
Upper resp tract infection. Nasopharyngitis, UTI, sinusitis, rhinitis; hypersensitivity; hyperglycaemia, DM; dizziness, headache; cough, oropharyngeal pain including throat irritation; dyspepsia, dental carries; bladder obstruction & urinary retention; pyrexia, chest pain.
Drug Interactions
Weakened or antagonised effect by β2-adrenergic blockers. Not recommended w/ anticholinergics. Potentiated adverse events w/ sympathomimetics. Potentiated hypokalaemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics.
MIMS Class
Antiasthmatic & COPD Preparations
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.
Ultibro Breezhaler inhalation powd cap
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