Onbrez Breezhaler

Onbrez Breezhaler

indacaterol

Manufacturer:

Novartis Indonesia

Marketer:

Wellesta
Concise Prescribing Info
Contents
Indacaterol maleate
Indications/Uses
Maintenance bronchodilator treatment of airflow obstruction in adult patients w/ COPD.
Dosage/Direction for Use
Adult Recommended dose: 150 mcg once-daily inhalation at the same time of the day each day. May be increased on medical advice. Max dose: 300 mcg once-daily.
Special Precautions
Do not use in asthma due to absence of long-term outcome data. May increase risk of asthma-related serious adverse events w/ long-acting β2-adrenergic agonists when used for the treatment of asthma. Discontinue immediately if hypersensitivity reactions, paradoxical bronchospasm & CV effects (eg, increase in pulse rate & BP) occur. Not indicated for the treatment of acute bronchospasm episodes eg, rescue therapy. CV disorders (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. Not to be used more often or at higher doses than recommended. Not to be used in conjunction w/ other long-acting β2-adrenergic agonists-containing medications. Hypokalemia, hyperglycemia. Monitor plasma glucose in diabetic patients. May inhibit labor due to relaxant effect on uterine smooth muscle. Pregnancy & lactation. Not to be used in childn <18 yr.
Adverse Reactions
Nasopharyngitis, URTI. Sinusitis; diabetes, hyperglycemia; headache, dizziness; ischemic heart disease, palpitations; cough, oropharyngeal pain including throat irritation, rhinorrhea; pruritus/rash; muscle spasm, musculoskeletal pain; chest pain, peripheral edema.
Drug Interactions
MAOIs, TCAs or drugs that prolong QT interval may potentiate effect & increase risk of ventricular arrhythmia. Concomitant administration of other sympathomimetic agents may potentiate AR. Methylxanthine derivatives, steroids or non-K-sparing diuretics may potentiate possible hypokalaemic effect. Weakened or antagonised effect by β-adrenergic blockers (including eye drops). Increased AUC & Cmax w/ potent & specific inhibitors of CYP3A4 & P-gp (ie, ketoconazole, erythromycin, verapamil & ritonavir).
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
(+ inhaler) 3 × 10's
Form
Onbrez Breezhaler inhalation powd cap 300 mcg
Packing/Price
(+ inhaler) 3 × 10's
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