FLUTICASONE-VILANTEROL (Generic for BREO ELLIPTA)

Fluticasone Furoate 200mcg/1actuation, Inhalation powder

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not eat grapefruit or drink grapefruit juice while taking Fluticasone without talking to your doctor or healthcare professional. Side effects from Fluticasone may get worse. Call your doctor or healthcare professional as soon as possible if you have side effects like roundness of the face, high blood pressure, extreme irritability, fainting, stomach pain, or water retention.

· Notes for Professionals: Instruct patients using inhaled fluticasone propionate products to avoid grapefruit juice. Patients using fluticasone furoate products should be aware of the potential for increased adverse effects if they regularly consume grapefruit juice. Increased systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression, may occur. Fluticasone is a CYP3A4 substrate; grapefruit juice is a strong CYP3A4 inhibitor. In drug interaction studies, coadministration with strong inhibitors increased plasma fluticasone propionate exposure resulting in 45% to 86% decreases in serum cortisol AUC. A strong inhibitor increased fluticasone furoate exposure by 1.33-fold with a 27% reduction in weighted mean serum cortisol; this change does not necessitate dose adjustment of fluticasone furoate.

Vilanterol 25mcg/1actuation, Inhalation powder

Caffeine-containing Foods/Beverages

· Severity: Moderate

· Notes for Consumers: Caffeine-sensitive persons may experience nausea, nervousness, palpitations, problems with sleep, rapid heartbeat, or other side effects. Some patients may need to limit or avoid excessive caffeine intake from foods, beverages, dietary supplements or medicines. Caffeine containing items include coffee, teas, colas, chocolate and some dietary supplements or non-prescription medicines.

· Notes for Professionals: Caffeine may enhance the cardiac inotropic effects of beta-agonists.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>