Wechselwirkungen · Tracleer
Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9
HOS-109936 · Präparat HOS-093279
Ketoconazole: Co-administration for 6 days of bosentan 62.5 mg twice daily with ketoconazole, a potent CYP3A4 inhibitor, increased the plasma concentrations of bosentan approximately 2-fold. No dose adjustment of Tracleer is considered necessary. Although not demonstrated through in vivo studies, similar increases in bosentan plasma concentrations are expected with the other potent CYP3A4 inhibitors (such as itraconazole or ritonavir). However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.
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) itraconazole (HOS-084516) ritonavir (HOS-084521) bosentan (HOS-086291)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-10-25T15:01:00Z · SHA-256 eddfcd40df26bd01c2c7847da53c544c94e0bafb8bcc62374b5c7788669470bc · Passage 952d7c2c68ef8030b7abcf275fd2bcf42069f7e4a3bd6fa57570b72d26500dbe · Zeichen 7461–8135 im Abschnitt