Onbrez Breezhaler

Onbrez Breezhaler

indacaterol

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Indacaterol maleate
Indications/Uses
Maintenance bronchodilator treatment of airflow obstruction in adult patients w/ COPD.
Dosage/Direction for Use
150 mcg once-daily inhalation at the same time daily. Max: 300 mcg once daily.
Special Precautions
Discontinue use if hypersensitivity reactions & paradoxical bronchospasm occur. Not to be used in asthma. Not for initial treatment of acute bronchospasm episodes ie, rescue therapy. CV disorders (eg, CAD, acute MI, cardiac arrhythmias, HTN), convulsive disorders or thyrotoxicosis, patients unusually responsive to β2-adrenergic agonists; known or suspected QT interval prolongation or patients treated w/ medicinal products affecting QT interval. Hypokalemia, hyperglycemia. Not to be used in conjunction w/ long-acting β2-adrenergic agonists-containing medications. Pregnancy & lactation. Severe hepatic impairment. Not to be used in ped <18 yr.
Adverse Reactions
Nasopharyngitis, upper resp tract infection. Sinusitis; diabetes, hyperglycaemia; headache, dizziness; ischaemic heart disease, palpitations; cough, oropharyngeal pain, rhinorrhea; pruritus/rash; muscle spasm, musculoskeletal pain; chest pain, peripheral oedema.
Drug Interactions
Pharmacodynamic interactions & increased risk of ventricular arrhythmias w/ antihistamines (eg, terfenadine, mizolastine), antiarrhythmics (eg, quinidine), phenothiazines, erythromycin, ritonavir, TCAs. Exacerbated adverse CV effects w/ sympathomimetics. Potentiated action on CV system w/ MAOIs, TCAs. Negative impact on cardiac tolerance w/ levodopa, levothyroxine, oxytocin. Potentiated hypokalemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Weakened or antagonised effect by β-adrenergic blockers.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AC18 - indacaterol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Onbrez Breezhaler inhalation powd cap 150 mcg
Packing/Price
30's
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