Wechselwirkungen · Daxas
Daxas 500 micrograms film-coated tablets · Abschnitt 4.5 · PDF-Seite 17
HOS-122858 · Präparat HOS-095587
A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2. Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase-4 (PDE4) inhibitory activity. Therefore, following administration of roflumilast, the total PDE4 inhibition is considered to be the combined effect of both roflumilast and roflumilast N-oxide. Interaction studies with CYP1A2/3A4 inhibitor enoxacin and the CYP1A2/2C19/3A4 inhibitors cimetidine and fluvoxamine, resulted in increases of the total PDE4 inhibitory activity of 25%, 47% and 59%, respectively. The tested dose of fluvoxamine was 50 mg. A combination of roflumilast with these active substances might lead to an increase of exposure and persistent intolerability. In this case, roflumilast treatment should be reassessed (see section 4.4).
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): cimetidine (HOS-085835) enoxacin (HOS-111703) lead (HOS-085592) fluvoxamine (HOS-085908)
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Version 2025-10-07T12:30:00Z · SHA-256 c9483b9b45da34f36b9555fd877e4e90626a238a341771b848d1c6fda96d3345 · Passage c0556a1ff166ece5c2fc355485d0046c7b1a1fe9793f731048420573676cb224 · Zeichen 57–899 im Abschnitt