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ULTIBRO BREEZHALER should not be administered concomitantly with products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, drug classes to which the components of ULTIBRO BREEZHALER belong (see Interactions).
Not for Acute Use: ULTIBRO BREEZHALER is not indicated for the treatment of acute episodes of bronchospasm.
Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are components of ULTIBRO BREEZHALER. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips and face), urticaria or skin rash, ULTIBRO BREEZHALER should be discontinued immediately and alternative therapy instituted.
Paradoxical Bronchospasm: As with other inhalation therapy, administration may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy must be instituted.
Anticholinergic effects related to glycopyrronium: Like other anticholinergic containing drugs, indacaterol/glycopyrronium (Ultibro Breezhaler) should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Patients should be advised about signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using it and to contact their doctor immediately should any of these signs or symptoms develop.
Patients with severe renal impairment: For patients with severe renal impairment (estimated glomerular filtration rate below 30 mL/min/1.73 m2) including those with end-stage renal disease requiring dialysis, it should be used only if the expected benefit outweighs the potential risk (see Pharmacology under Actions). These patients should be monitored closely for potential adverse drug reactions.
Systemic effects of beta-agonists: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of indacaterol/glycopyrronium (Ultibro Breezhaler) at the recommended dose, as with other compounds containing a beta2-adrenergic agonist, it 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 beta2-adrenergic agonists.
As with other drugs containing an inhaled beta2-adrenergic agonist, it should not be used more often or at higher doses than recommended.
Cardiovascular effects of beta-agonists: Like other drugs containing a beta2-adrenergic agonist, it 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, the drug may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of QT interval, and ST segment depression, although the clinical significance of these findings is unknown.
Therefore, long-acting beta2-adrenergic agonists (LABA) or LABA containing products such as ULTIBRO BREEZHALER should be used with caution in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval.
Hypokalaemia with beta-agonists: Beta2-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, hypokalemia may be potentiated by hypoxia and concomitant treatment (see Interactions) which may increase the susceptibility to cardiac arrhythmias.
Clinically relevant effects of hypokalemia have not been observed in clinical studies of indacaterol/glycopyrronium (Ultibro Breezhaler) at the recommended therapeutic dose (see Pharmacology under Actions).
Hyperglycaemia with beta-agonists: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with indacaterol/glycopyrronium (Ultibro Breezhaler), plasma glucose should be monitored more closely in diabetic patients. During long-term clinical studies ([ENLIGHTEN] and [RADIATE]), more patients on indacaterol/glycopyrronium (Ultibro Breezhaler) experienced clinically notable changes in blood glucose (4.9%) than on placebo (2.7%). It has not been investigated in patients for whom diabetes mellitus is not well controlled.
General disorders: Ultibro Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency orglucose-galactose malabsorption should not take this medicine.
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