Wechselwirkungen · Pradaxa
Pradaxa 150 mg hard capsules · Abschnitt 4.5 · PDF-Seite 84
HOS-118796 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily. Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg. Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected. cyclosporine Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 638–1714 im Abschnitt