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Relvar Ellipta

Relvar Ellipta Dosage/Direction for Use

Manufacturer:

GlaxoSmithKline

Distributor:

GlaxoSmithKline
Full Prescribing Info
Dosage/Direction for Use
Asthma: Adults and adolescents aged 12 years and over: One inhalation of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100 mcg/25 mcg once daily.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta).
However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
A starting dose of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100/25 micrograms should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta2-agonist. If patients are inadequately controlled on Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100/25 micrograms, the dose can be increased to 200/25 micrograms, which may provide additional improvement in asthma control.
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 200/25 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Patients with asthma should be given the strength of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone furoate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Children aged under 12 years: The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
No data are available.
COPD: Adults aged 18 years and over: One inhalation of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100/25 micrograms once daily.
Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 200/25 micrograms is not indicated for patients with COPD. There is no additional benefit of the 200/25 micrograms dose compared to the 100/25 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions.
Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Relvar Ellipta.
Paediatric population: There is no relevant use of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) in the paediatric population in the indication for COPD.
Special populations: Elderly patients (>65 years): No dose adjustment is required in this population.
Renal impairment: No dose adjustment is required in this population.
Hepatic impairment: Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC).
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
For patients with moderate or severe hepatic impairment the maximum dose is 100/25 micrograms.
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