Wechselwirkungen · Relvar Ellipta
Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed · Abschnitt 4.5 · PDF-Seite 8
HOS-128384 · Präparat HOS-096557
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid undesirable effects, in which case patients should be monitored for systemic corticosteroid undesirable effects. A repeat dose CYP3A4 drug interaction study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and the strong CYP3A4 inhibitor ketoconazole (400 mg). Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively. The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol. Co-administration increased mean vilanterol AUC(0-t) and Cmax 65% and 22%,
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ketoconazole (HOS-084513) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-04-10T11:43:00Z · SHA-256 ae80777ab6b52d24a5268a5989d61a006f952cc42bf17fad0fcab526c332f7e3 · Passage d8ff920988a7bf80c1610a387c44593574fcb11c18d023c171437263cbaa3bc3 · Zeichen 689–1706 im Abschnitt