Glycoair Breezhaler

Glycoair Breezhaler

indacaterol + glycopyrronium

Manufacturer:

Novartis Healthcare

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Indacaterol maleate 110 mcg, glycopyrronium Br 50 mcg
Indications/Uses
Relieve symptoms & reduce exacerbations of COPD in adult patients.
Dosage/Direction for Use
1 cap once-daily inhalation at the same time each day.
Contraindications
Hypersensitivity to indacaterol or glycopyrronium.
Special Precautions
Not to be used for the treatment of asthma & acute episodes of bronchospasm. Discontinue immediately if paradoxical bronchospasm & allergic reactions occur. Patients w/ narrow-angle glaucoma or urinary retention; CV & convulsive disorders or thyrotoxicosis; those unusually responsive to β2-adrenergic agonists; severe COPD, hypokalemia & hyperglycemia. QTc interval prolongation may occur. Do not co-administer w/ products containing other long-acting β-adrenergic agonists or muscarinic antagonists. Severe renal (GFR <30 mL/min/1.73 m2) or hepatic impairment, or end-stage renal disease requiring dialysis. Pregnancy & lactation. Not to be used in 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 effects w/ β-adrenergic blockers (including eye drops). May potentiate effects w/ MAOIs, TCAs or drugs known to prolong QT interval. May potentiate adverse reactions w/ sympathomimetic agents. May potentiate possible hypokalemic effect w/ methylxanthine derivatives, steroids, or non-K-sparing diuretics. Glycopyrronium: Increased total exposure (AUC) & decreased renal clearance w/ cimetidine or other inhibitors or organic cation transport. Anticholinergics.
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
Glycoair Breezhaler powd for inhalation
Packing/Price
(+ inhaler device) 30's; (+ inhaler device) 6's
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