Relvar Ellipta

Relvar Ellipta

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
100/25 mcg inhalation powd Fluticasone furoate 100 mcg, vilanterol trifenatate 25 mcg. 200/25 mcg inhalation powd Fluticasone furoate 200 mcg, vilanterol trifenatate 25 mcg
Indications/Uses
Regular treatment of asthma in adult & adolescent ≥12 yr & not adequately controlled w/ inhaled corticosteroid & "as needed" inhaled short-acting β2-agonist. Symptomatic treatment of adult w/ COPD w/ FEV1 <70% predicted normal w/ exacerbation history despite regular bronchodilator therapy.
Dosage/Direction for Use
Adult & adolescent ≥12 yr 1 inhalation of 100/25 mcg or 200/25 mcg once daily. Starting dose: 100/25 mcg, increase to 200/25 mcg. COPD Adult 1 inhalation of 100/25 mcg once daily. Patient w/ moderate or severe hepatic impairment Max: 100/25 mcg.
Contraindications
Hypersensitivity. Patient w/ severe milk-protein allergy.
Special Precautions
Do not use to treat acute asthma symptoms or an acute exacerbation in COPD. Discontinue immediately if paradoxical bronchospasm occurs. Cardiac arrhythmias (eg, supraventricular tachycardia & extrasystoles). Systemic effects may occur w/ inhaled corticosteroids particularly at high doses prescribed for long periods. Patient w/ pulmonary TB or in patients w/ chronic or untreated infections. Visual disturbances may occur. History of or w/ risk factors for DM. Pneumonia in patients w/ COPD & asthma. Immunosuppression. Concomitant use of long-acting β2-adrenergic agonists. Hepatic impairment. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Headache; nasopharyngitis. Pneumonia, upper resp tract infection, bronchitis, influenza, candidiasis of mouth & throat; oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia; abdominal pain; arthralgia, back pain, fractures; pyrexia.
Drug Interactions
Weakened or antagonized effect w/ β-adrenergic blockers. Increased systemic exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Potentiated adverse reactions w/ other sympathomimetic drugs.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AK10 - vilanterol and fluticasone furoate ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Relvar Ellipta inhalation powd 100 mcg/25 mcg
Packing/Price
30's
Form
Relvar Ellipta inhalation powd 200 mcg/25 mcg
Packing/Price
30's
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