Relvar Ellipta Dosage/Direction for Use

RELVAR ELLIPTA is for inhalation only.
Asthma: Patients should be made aware that RELVAR ELLIPTA must be used regularly, even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta₂-agonist should be taken for immediate relief.
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.
Adults and Adolescents Aged 12 Years and Over: The recommended dose of RELVAR ELLIPTA is: One inhalation of RELVAR ELLIPTA 100/25 micrograms once daily or one inhalation of RELVAR ELLIPTA 200/25 micrograms once daily.
A starting dose of RELVAR ELLIPTA 100/25 micrograms should be considered for patients who require a low to mid dose of inhaled corticosteroid in combination with a long acting beta₂-agonist.
RELVAR ELLIPTA 200/25 micrograms should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a long acting beta₂-agonist.
If patients are inadequately controlled on RELVAR ELLIPTA 100/25 micrograms, consider increasing the dose to 200/25 micrograms, which may provide additional improvement in asthma control.
Children: The safety and efficacy of RELVAR ELLIPTA has not been established in children less than 12 years of age.
COPD: Adults: The recommended dose of RELVAR ELLIPTA is: One inhalation of RELVAR ELLIPTA 100/25 micrograms once daily.
RELVAR ELLIPTA 200/25 micrograms is not indicated for patients with COPD.
Children: The use in children is not relevant given the COPD indication for this product.
Special Population: Asthma and COPD: Elderly: No dosage adjustment is required in patients over 65 years (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
Renal Impairment: No dose adjustment is required for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: A clinical pharmacology study in subjects with mild, moderate and severe hepatic impairment showed up to 3-fold increase in systemic exposure to fluticasone furoate (AUC) (see Pharmacology: Pharmacokinetics under Actions).
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 (see Pharmacology: Pharmacokinetics under Actions).
Administration: RELVAR ELLIPTA should be administered once daily either morning or evening but at the same time every day.
After inhalation, the patient should rinse their mouth with water without swallowing.