Trelegy Ellipta

Trelegy Ellipta

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per inhalation Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg
Indications/Uses
Maintenance treatment to prevent & relieve symptoms associated w/ moderate to severe COPD in patients not adequately treated by inhaled corticosteroid & long-acting β2-agonist combination or long-acting β2-agonist & long-acting muscarinic antagonist combination.
Dosage/Direction for Use
Recommended & max dose: 1 inhalation once daily (same time each day).
Contraindications
Hypersensitivity. Patients w/ severe milk-protein allergy.
Special Precautions
Not recommended in patients w/ asthma. Not to be used for acute symptom relief ie, rescue therapy for bronchospasm acute episodes. Discontinue immediately if paradoxical bronchospasm occurs. Patients w/ unstable or life-threatening CV disease; pulmonary TB or w/ chronic or untreated infections; narrow-angle glaucoma or urinary retention. Systemic effects may occur particularly at high doses for long periods. Possible pneumonia development in COPD patients; risk factors include current smokers, patients w/ prior pneumonia history, low BMI, severe COPD; re-evaluate treatment if pneumonia occurs. Blurred vision or other visual disturbances. Increased blood glucose levels in patients w/ DM history or risk factors. May affect ability to drive & use machines. Moderate to severe hepatic impairment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Pneumonia, upper resp tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, flu, nasopharyngitis, mouth & throat candidiasis, UTI; headache; cough, oropharyngeal pain; constipation; arthralgia, back pain.
Drug Interactions
May weaken or antagonise effects of β2-adrenergic agonists (eg, vilanterol) w/ β-adrenergic blockers. Caution during concurrent use w/ non-selective & selective β-blockers. Potentially, increased systemic exposure to both fluticasone furoate & vilanterol w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). May potentiate AR w/ other long-acting muscarinic antagonists or long-acting β2-adrenergic agonists.
ATC Classification
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.
Presentation/Packing
Form
Trelegy Ellipta 100/62.5/25 mcg inhalation powd
Packing/Price
30's
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