Onbrez Breezhaler Special Precautions

Asthma: ONBREZ BREEZHALER should not be used in asthma due to the absence of long-term outcome data in asthma with ONBREZ BREEZHALER.
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of ONBREZ BREEZHALER. If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, ONBREZ BREEZHALER should be discontinued immediately and alternative therapy instituted.
Paradoxical Bronchospasm: As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Onbrez Breezhaler should be discontinued immediately and alternative therapy instituted.
Deterioration of Disease: Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm ie, as a rescue therapy. In case of deterioration of chronic obstructive pulmonary disease (COPD) whilst on treatment with Onbrez Breezhaler, a re-evaluation of the patient and the COPD treatment regimen should be undertaken. An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose is not appropriate.
Systemic Effects: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other β₂-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to β₂-adrenergic agonists.
As with other inhaled β₂-adrenergic drugs, Onbrez Breezhaler should not be used more often or at higher doses than recommended.
Onbrez Breezhaler should not be used in conjunction with other long-acting β₂-adrenergic agonists or medications containing long-acting β₂-adrenergic agonists.
Cardiovascular Effects: Like other β₂-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, Onbrez Breezhaler may need to be discontinued. In addition, β-adrenergic agonists have been reported to produce electrocardiogram changes eg, flattening of the T-wave and ST-segment depression, although the clinical significance of these findings is unknown.
Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see Pharmacology under Actions).
Hypokalaemia: β₂-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see Interactions) which may increase the susceptibility to cardiac arrhythmias.
Hyperglycaemia: Inhalation of high doses of β₂-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with Onbrez Breezhaler, plasma glucose should be monitored more closely in diabetic patients.
During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez Breezhaler at the recommended doses than on placebo. This product has not been investigated in patients with not well-controlled diabetes mellitus.
Effects on the Ability to Drive or Operate Machinery: Onbrez Breezhaler has no or negligible influence on the ability to drive and use machines.