Glycoair Breezhaler Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Indacaterol maleate 110 mcg, glycopyrronium Br 50 mcg

Indications/Uses

Relieve symptoms & reduce exacerbations of COPD in adult patients.

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Dosage/Direction for Use

1 cap once-daily inhalation at the same time each day.

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Overdosage

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Contraindications

Hypersensitivity to indacaterol or glycopyrronium.

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Special Precautions

Do not use as treatment of asthma & acute episodes of bronchospasm. May increase the risk of asthma-related serious adverse events, including asthma-related deaths if used as treatment for asthma. Discontinue immediately if paradoxical bronchospasm & allergic reactions occur. Patients w/ narrow-angle glaucoma or urinary retention; CV (eg, CAD, acute MI, cardiac arrhythmias, HTN) & convulsive disorders or thyrotoxicosis; those unusually responsive to β₂-adrenergic agonists. Severe COPD, hypokalemia & hyperglycemia. Closely monitor plasma glucose upon initiation of treatment. ECG changes eg, flattening of T wave, prolongation of QT interval, & ST segment depression 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 ESRD requiring dialysis. Pregnancy & lactation. Do not use in childn <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI. 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.

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Drug Interactions

Indacaterol: May weaken or antagonize effects w/ β₂-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 of organic cation transport. Co-administration w/ anticholinergics.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Glycoair Breezhaler detailed prescribing information

Storage

View Glycoair Breezhaler storage conditions for details to ensure optimal shelf-life.

Description

View Glycoair Breezhaler description for details of the chemical structure and excipients (inactive components).

Action

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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.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Glycoair Breezhaler powd for inhalation

Packing/Price

(+ inhaler device) 30's; (+ inhaler device) 6's

Glycoair Breezhaler

indacaterol + glycopyrronium bromide

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc