Ultibro Breezhaler

Ultibro Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Indacaterol maleate 143 mcg (equiv to indacaterol 110 mcg), glycopyrronium Br 63 mcg (equiv to glycopyrronium 50 mcg)
Indications/Uses
Relief of symptoms & reduce exacerbations in patients w/ COPD.
Dosage/Direction for Use
Special Precautions
Severe renal impairment including end-stage renal disease. Concomitant use w/ drugs containing other long-acting β-adrenergic agonists or long-acting muscarinic antagonists. Not for treatment of asthma & acute episodes of bronchospasm. Discontinue upon signs of allergy reactions, angioedema, (eg, difficulty in breathing or swallowing, swelling of tongue, lips & face), urticaria or skin rash & paradoxical bronchospasm; upon increase in pulse rate, BP &/or symptoms of CV effects. Narrow-angle glaucoma or urinary retention. CV disorders (CAD, acute, MI, cardiac arrhythmias, HTN), convulsive disorders or thyrotoxicosis, patients unusually responsive to β2-adrenergic agonists. Hypokalemia in patients w/ severe COPD. Monitor blood glucose in diabetic patients. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Upper resp tract infection; nasopharyngitis, UTI, sinusitis, rhinitis. Dizziness, headache. Cough, oropharyngeal pain including throat irritation. Dyspepsia, dental caries. Musculoskeletal pain. Pyrexia, chest pain.
Drug Interactions
May weaken antagonize the effect of β2-adrenergic agonists. QT interval may be potentiated w/ MAOI's, TCAs or drugs known to prolong QT interval. Concomitant use w/ other sympathomimetic agents may potentiate adverse effects. Potentiated possible hypokalemic effects of β2-adrenergic agonists w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Inhaled anticholinergics 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
5 × 6's
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