Trelegy Ellipta

Trelegy Ellipta

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma

Marketer:

GlaxoSmithKline
Concise Prescribing Info
Contents
Each dose Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg (equiv to 74.2 mcg umeclidinium Br), vilanterol trifenatate 25 mcg
Indications/Uses
Maintenance treatment of adults w/ moderate to severe COPD requiring treatment w/ combination of long-acting muscarinic antagonist, long-acting β2-agonist & inhaled corticosteroid.
Dosage/Direction for Use
Recommended & max dose: 1 inhalation once daily at the same time each day.
Contraindications
Hypersensitivity. Patients w/ severe milk-protein allergy.
Special Precautions
Discontinue if paradoxical bronchospasm w/ immediate increase in wheezing after dosing occurs. Not to be used for acute symptom relief ie, as rescue therapy for acute episodes of bronchospasm. CV effects eg, cardiac arrhythmias (atrial fibrillation & tachycardia). Possible systemic effects include hypothalamic‐pituitary‐adrenal suppression, decreased bone mineral density, cataract, glaucoma & central serous chorioretinopathy. Possible pneumonia development in COPD patients. Patients w/ narrow-angle glaucoma or urinary retention; history of prior pneumonia, low BMI & severe COPD; stomach or intestinal ulcers, DM, viral infections; smokers. Monitor patients w/ moderate to severe hepatic impairment for systemic corticosteroid-related adverse reactions. Severe hepatic impairment. Pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Nasopharyngitis. Pneumonia, URTI, bronchitis, pharyngitis, rhinitis, sinusitis, flu, mouth & throat candidiasis, UTI, viral resp tract infection; headache; cough, oropharyngeal pain, dysphonia; constipation; arthralgia, back pain.
Drug Interactions
Weakened or antagonised effect of β2-adrenergic agonists eg, vilanterol w/ β-adrenergic blockers. Increased systemic exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir. Potentiated effect of adrenergic agonists on CV system w/ MAOIs, TCAs or drugs prolonging QTc interval. Not recommended in co-administration w/ other long-acting muscarinic antagonists or β2-adrenergic agonists. Potentiated possible hypokalaemic effect of β2-adrenergic agonists w/ methylxanthine derivatives, steroids or non-K-sparing diuretics.
MIMS Class
Antiasthmatic & COPD Preparations
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 doses) ) 1's
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