Wechselwirkungen · Isturisa
Isturisa 1 mg film-coated tablets Isturisa 5 mg film-coated tablets Isturisa 10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6
HOS-142180 · Präparat HOS-098768
In a healthy volunteer study (n=24), osilodrostat (30 mg twice daily for 7 days before concomitant administration with a combined oral contraceptive containing 0.03 mg ethinyl oestradiol and 0.15 mg levonorgestrel and continued for another 5 days) did not have a clinically meaningful effect on the AUC and maximum serum concentration (Cmax) of ethinyl estradiol (geometric mean ratio: 1.03 and 0.88, respectively) and AUC of levonorgestrel (geometric mean ratio: 1.02). The Cmax of levonorgestrel fell slightly outside the bioequivalence acceptance range (geometric mean ratio: 0.86; 90% confidence interval : 0.737-1.00). The effects of a longer induction period and an interaction with other hormonal contraceptives have not been studied (see also sections 4.4 and 4.6).
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): levonorgestrel (HOS-089677) ethinyl estradiol (HOS-088135)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-12-12T15:32:00Z · SHA-256 13107ffe0035bb183c6ee6076a8db3da498ecb30795369b80b898d43d73d46cc · Passage 70456348e77ad42d13689e5eea03981e81ad28ead6ec5e6e8221837b94b2af84 · Zeichen 3010–3783 im Abschnitt