Trelegy Ellipta

Per 100/62.5/25 mcg inhalation Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg. Per 200/62.5/25 mcg inhalation Fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg

Long-term, once-daily, maintenance treatment of asthma in patients ≥18 yr who are inadequately controlled w/ a maintenance combination of a medium- or high-dose ICS & LABA. 100/62.5/25 mcg inhalation: Long-term, once-daily, maintenance treatment of COPD (including chronic bronchitis &/or emphysema) & COPD exacerbations in adult patients who are inadequately treated by a combination of inhaled corticosteroid (ICS)/long-acting β₂-adrenergic agonist (LABA) or a combination of long-acting muscarinic antagonist (LAMA)/LABA.

Adult ≥18 yr Asthma Recommended dose: 1 inhalation of 100/62.5/25 mcg or 200/62.5/25 mcg once daily administered at the same time each day. COPD Recommended & max dose: 1 inhalation of 100/62.5/25 mcg once daily administered at the same time each day. Patient w/ moderate or severe hepatic impairment Max dose: 100/62.5/25 mcg.

Hypersensitivity. Patients w/ severe hypersensitivity to milk proteins.

Discontinue treatment in case of hypersensitivity reactions or paradoxical bronchospasm. Do not use for the relief of acute symptoms of COPD or asthma (ie, as rescue therapy for acute episodes of bronchospasm). Do not initiate in patients w/ acutely deteriorating COPD or asthma. Do not use more often or at higher doses than recommended. Rinse mouth w/ water (w/o swallowing) after inhalation to reduce the risk of oropharyngeal candidiasis. Antimuscarinic effects; caution in patients w/ narrow angle glaucoma or urinary retention. Risk of CV effects (eg, tachycardia, arrhythmia, palpitations, myocardial ischemia, angina pectoris, HTN or hypotension, ECG changes). Possible systemic effects include Cushing's syndrome, Cushingoid features, hypothalamic-pituitary-adrenal axis suppression, growth retardation in childn & adolescents (in asthma), decrease in bone mineral density (BMD), cataracts, glaucoma, & central serous chorioretinopathy. Observe patients post-op or during periods of stress for evidence of inadequate adrenal response. Risk of death due to adrenal insufficiency in asthma patients during & after transfer from systemic to inhaled corticosteroids. Transfer of patients from systemic to inhaled corticosteroid may unmask allergic conditions previously suppressed by systemic therapy. Assess BMD prior to treatment initiation & periodically thereafter. β-adrenergic agonists may produce significant hypokalemia &/or transient hyperglycemia. Monitor serum K levels in patients predisposed to low levels of serum K. Additional blood glucose monitoring is recommended in diabetic patients. Risk of systemic eosinophilic conditions. Increased susceptibility to infections. Increased risk of pneumonia. Do not co-administer w/ other medicines containing a LABA (eg, salmeterol, formoterol fumarate, indacaterol, olodaterol) or a LAMA (eg, tiotropium, glycopyrronium, aclidinium, umeclidinium). Caution in patients w/ convulsive disorders or thyrotoxicosis & in those who are unusually responsive to sympathomimetic amines. Occurrence of headache or blurred vision may influence the ability to drive or use machinery. Monitor patients w/ hepatic impairment for corticosteroid-related systemic effects. Umeclidinium has not been evaluated in subjects w/ severe hepatic impairment. Consider use during pregnancy & lactation only if potential benefit justifies potential risk. Do not use in patients <18 yr. 200/62.5/25 mcg inhalation: Not indicated for COPD treatment.

Asthma: Nasopharyngitis, URTI, bronchitis, viral resp tract infection, sinusitis, viral URTI, pharyngitis, UTI, rhinitis, flu, pneumonia, resp tract infection; headache; back pain; oropharyngeal pain, cough, dysphonia. COPD: Constipation; URTI, pneumonia, oral candidiasis, bronchitis, flu, sinusitis, UTI, pharyngitis, rhinitis, nasopharyngitis, viral resp tract infection; back pain, arthralgia; headache; cough, oropharyngeal pain.

Potentiated effect on QT interval w/ MAOIs, TCAs, or drugs known to prolong the QT interval. Potentiated undesirable effects w/ other sympathomimetic agents. Potentiated hypokalemic effect of adrenergic agonists w/ xanthine derivatives, oral corticosteroids (eg, prednisone), or non-K-sparing diuretics. Weakened or antagonized effect of vilanterol w/ β-adrenergic blockers (including eye drops). Inhibited metabolism of & increased systemic exposure to fluticasone furoate & vilanterol w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, ritonavir, indinavir, lopinavir, nelfinavir, saquinavir, clarithromycin, atazanavir, cobicistat-containing products). Altered systemic exposure to umeclidinium & vilanterol w/ P-gp inhibitors. Potential for additive interaction w/ anticholinergics. Caution w/ concomitant use of ASA & corticosteroids in hypoprothrombinemia.

Antiasthmatic & COPD Preparations

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.

P₁S₁S₃