Per inhalation Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg
Indications/Uses
Maintenance treatment in adults w/ moderate to severe COPD who are inadequately treated by a combination of an inhaled corticosteroid & a long-acting β2-agonist or a combination of a long-acting β2-agonist & a long-acting muscarinic antagonist.
Should not be used in patients w/ asthma. Not for acute episodes of bronchospasm, or treatment of acute COPD exacerbation. Discontinue treatment if paradoxical bronchospasm occurs. In the event of COPD deterioration during treatment, re-evaluate patient & treatment regimen should be undertaken. Therapy should not be stopped w/o physician supervision. Patients w/ unstable or life-threatening CV disease; convulsive disorders or thyrotoxicosis & who are unusually responsive to β2-adrenergic agonists; pulmonary TB or w/ chronic or untreated infections; narrow-angle glaucoma or urinary retention. Systemic effects may occur particularly at high doses prescribed for long periods. Visual disturbance may be reported. Possible development of pneumonia in patients w/ COPD. Concomitant use w/ other medicinal products that have the potential to cause hypokalaemia. Monitor plasma glucose upon initiation of treatment in diabetic patients. Not to be used in patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Monitor for systemic corticosteroid-related AR in patients w/ moderate to severe hepatic impairment. Pregnancy & breast-feeding.
Weakened or antagonised effect of β2-adrenergic agonists eg, vilanterol w/ β-adrenergic blockers. Potential for increased systemic exposure to both fluticasone furoate & vilanterol w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, cobicistat-containing products). May potentiate ARs w/ other long-acting muscarinic antagonists or long-acting β2-adrenergic agonists. May potentiate possible hypokalaemic effect of β2-adrenergic agonists w/ methylxanthine derivatives, steroids, or non-K-sparing diuretics.
R03AL08 - vilanterol, umeclidinium bromide and fluticasone furoate ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Sign Out
