Relvar Ellipta

Relvar Ellipta

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 100/25 mcg inhalation Predispensed fluticasone furoate 100 mcg, vilanterol trifenatate 25 mcg (delivered dose of fluticasone furoate 92 mcg, vilanterol trifenatate 22 mcg). Per 200/25 mcg inhalation Predispensed fluticasone furoate 200 mcg, vilanterol trifenatate 25 mcg (delivered dose of fluticasone furoate 184 mcg, vilanterol trifenatate 22 mcg)
Indications/Uses
Regular treatment of asthma in adults & adolescents ≥12 yr not adequately controlled w/ inhaled corticosteroid & "as needed" inhaled short-acting β2-agonist. 100/25 mcg inhalation: Symptomatic treatment of adults w/ COPD w/ FEV1 <70% predicted normal w/ an exacerbation history despite regular bronchodilator therapy.
Dosage/Direction for Use
Asthma Adult & adolescent ≥12 yr 1 inhalation of 100/25 mcg once daily, may be increased up to max: 200/25 mcg once daily. COPD Adult ≥18 yr 1 inhalation of 100/25 mcg once daily. Moderate or severe hepatic impairment Max: 100/25 mcg once daily.
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not to be used in symptomatic treatment of acute asthma or acute COPD exacerbation. Severe CV disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low serum K levels. Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression; pulmonary TB or patients w/ chronic or untreated infections. Pneumonia in patients w/ COPD or asthma. History of DM. High-dose & long-term use. Concomitant use w/ β-blockers, P-gp & CYP3A4 (eg, ketoconazole, ritonavir) inhibitors or sympathomimetic drugs. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation. Growth retardation in childn & adolescents. Childn <12 yr. 200/25 mcg inhalation: Not to be used in patients w/ COPD.
Adverse Reactions
Headache; nasopharyngitis. Pneumonia, upper resp tract infection, bronchitis, flu, mouth & throat candidiasis; oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia; abdominal pain; arthralgia, back pain, fractures, muscle spasms; pyrexia.
Drug Interactions
Weakened or antagonized effect by β-blockers. Increased systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole, ritonavir. Potentiated AR 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 100/25 mcg
Packing/Price
30's
Form
Relvar Ellipta inhalation powd 200/25 mcg
Packing/Price
30's
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