Not for acute use. Not indicated for treatment of acute episodes of bronchospasm ie, as rescue therapy. May produce paradoxical bronchospasm w/ immediate wheezing & shortness of breath after dosing & may be life threatening. Discontinue treatment immediately if paradoxical bronchospasm occurs. Do not stop treatment abruptly in case of disease deterioration. CV effects eg, cardiac arrhythmias (atrial fibrillation & tachycardia). Patients w/ clinically significant uncontrolled & severe CV disease eg, unstable ischemic heart disease, acute MI, cardiomyopathy, cardiac arrhythmias, & severe heart failure; known or suspected prolongation of QTc interval, either congenital or induced by medicinal products. Systemic effects including Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract & glaucoma may occur w/ any inhaled corticosteroid, particularly at high doses prescribed for long periods. Consider potential effects on bone density particularly in patients on high doses for prolonged periods that have co existing risk factors for osteoporosis. Visual disturbance w/ systemic & topical corticosteroid use. Consider ophth evaluation if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Risk of impaired adrenal function in patients transferring from oral steroids, &/or those who have required high dose corticosteroid therapy or prolonged treatment at highest recommended dose of inhaled corticosteroids. Increased incidence of pneumonia, including pneumonia requiring hospitalisation, in patients w/ COPD receiving inhaled corticosteroids. Potentially serious hypokalaemia may result from β
2-agonist therapy & produce adverse CV effects. Hypokalaemia may be potentiated by hypoxia in severe COPD; concomitant use w/ other medicinal products which can induce hypokalaemia eg, xanthine derivatives, steroids & diuretics. Inhalation of high doses of β
2-adrenergic agonists may produce increases in plasma glucose; monitor blood glucose during treatment. Patients w/ thyrotoxicosis; symptomatic prostatic hyperplasia, urinary retention or w/ narrow-angle glaucoma due to anticholinergic activity. Stop use if signs &/or symptoms of acute narrow-angle glaucoma develop. Not recommended w/ other anticholinergic containing medicinal products. Severe renal & hepatic impairment, or ESRD requiring dialysis. Pregnancy & lactation. No relevant use in childn & adolescents <18 yr.
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