Wechselwirkungen · Tracleer
Tracleer 32 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 31
HOS-109979 · Präparat HOS-093279
Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case. As a result, a significantly reduced effect of bosentan is expected when it is co-administered with rifampicin. Concomitant use of rifampicin and Tracleer is not recommended. Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John’s wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.
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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) lead (HOS-085592) bosentan (HOS-086291) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-10-25T15:01:00Z · SHA-256 eddfcd40df26bd01c2c7847da53c544c94e0bafb8bcc62374b5c7788669470bc · Passage a30be20bb22004903f151f7e54a6dd8796bf6a4aaf6a5fc5d7df9c1a1589bcfd · Zeichen 3191–3913 im Abschnitt