Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per cap Indacaterol 110 mcg, glycopyrronium 50 mcg. Each delivered dose (via mouthpiece of the inhaler): Indacaterol 85 mcg, glycopyrronium 43 mcg
Indications/Uses
Maintenance bronchodilator treatment to relieve symptoms in adult patients w/ COPD. Reduction of exacerbations of COPD in patients w/ a history of exacerbations.
Dosage/Direction for Use
Contraindications
Hypersensitivity. Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
Special Precautions
Not for the treatment of asthma & acute episodes of bronchospasm. Discontinue immediately if hypersensitivity & paradoxical bronchospasm occurs. Use w/ caution in patients w/ narrow-angle glaucoma, urinary retention; CV disorders (CAD, acute MI, cardiac arrhythmia, HTN), unstable ischaemic heart disease, left ventricular failure, history of long QT syndrome or MI, convulsive disorders or thyrotoxicosis. May produce significant hypokalaemia or hyperglycaemia. Be alert for signs & symptoms of prostatic hyperplasia or bladder-neck obstruction (eg, difficulty passing urine, painful urination). Monitor plasma glucose in diabetic patients. Concomitant use w/ long-acting β-adrenergic agonists or muscarinic antagonists. May affect ability to drive or operate machinery. Severe renal & hepatic impairment. May inhibit labor due to a relaxant effect on uterine smooth muscle. Pregnancy & lactation. Childn <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 caries; bladder obstruction & urinary retention; pyrexia, chest pain.
Drug Interactions
Indacaterol: Weakened or antagonized effect w/ β-adrenergic blockers. Potentiated effects on QT interval w/ TCAs, MAOIs, or drugs known to prolong the QT interval. Potentiated adverse effects w/ sympathomimetic agents. Potentiated possible hypokalaemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Glycopyrronium: Co-administration w/ anticholinergics is not recommended.
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.
Presentation/Packing
Form
Ultibro Breezhaler inhalation powd cap 110 mcg/50 mcg
Packing/Price
30's
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