Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis Indonesia

Marketer:

Wellesta
Concise Prescribing Info
Contents
Indacaterol 110 mcg, glycopyrronium 50 mcg
Indications/Uses
Once-daily maintenance bronchodilator treatment to relieve symptoms & reduce exacerbations in patients w/ moderate to very severe COPD still symptomatic despite treatment w/ indacaterol or glycopyrronium alone or the combination of salmeterol/fluticasone. Once-daily maintenance bronchodilator treatment to relieve symptoms in patients w/ moderate to severe COPD still symptomatic despite treatment w/ tiotropium alone.
Dosage/Direction for Use
1 cap once daily inhalation at the same time of the day each day.
Contraindications
Hypersensitivity to indacaterol or glycopyrronium.
Special Precautions
Not to be administered concomitantly w/ other long-acting β-adrenergic agonists or long-acting muscarinic antagonists. Not for the treatment of asthma &/or acute episodes of bronchospasm. Discontinue immediately if hypersensitivity &/or paradoxical bronchospasm occurs. Narrow-angle glaucoma or urinary retention; CV disorders (eg, CAD, acute MI, cardiac arrhythmias, HTN); convulsive disorders or thyrotoxicosis, patients unusually responsive to β2-adrenergic agonists. Not to be used more often or at higher doses than recommended. Discontinue upon increase in pulse rate, BP &/or symptoms of CV effects. Hypokalemia may be potentiated by hypoxia & concomitant treatment which may increase susceptibility to cardiac arrhythmias in patients w/ severe COPD. May increase plasma glucose w/ high dose. Closely monitor plasma glucose in diabetic patients upon initiation. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal impairment or ESRD requiring dialysis. Pregnancy & lactation. May inhibit labor due to relaxant effect on uterine smooth muscle. Not to be used in 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 carries; bladder obstruction & urinary retention; pyrexia, chest pain.
Drug Interactions
Indacaterol: Weakened or antagonized effect by β2-adrenergic blockers. Not to be given together w/ β-adrenergic blockers (including eye drops). 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.
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
Packing/Price
(+ 1 inhaler) 1 × 6's; (+ 1 inhaler) 2 × 6's; (+ 1 inhaler) 3 × 10's; (+ 1 inhaler) 5 × 6's
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