Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 63–64

HOS-134634 · Präparat HOS-097580

63  INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Recommendations concerning co- therapeutic areas Geometric mean change (%) administration For the treatment of Not studied. Concomitant use of A safe and effective dose of sildenafil pulmonary arterial sildenafil or tadalafil for the for the treatment of pulmonary hypertension treatment of pulmonary arterial arterial hypertension co-administered Sildenafil hypertension and boosted darunavir with boosted darunavir has not been Tadalafil may increase plasma concentrations established. There is an increased of sildenafil or tadalafil. potential for sildenafil-associated (CYP3A inhibition) adverse events (including visual disturbances, hypotension, prolonged erection and syncope). Therefore, co- administration of boosted darunavir and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with boosted darunavir is not recommended. PROTON PUMP INHIBITORS Omeprazole # darunavir AUC ↔ Boosted darunavir can be co- 20 mg once daily # darunavir Cmin ↔ administered with proton pump # darunavir Cmax ↔ inhibitors without dose adjustments. SEDATIVES/HYPNOTICS Buspirone Not studied. Sedative/hypnotics are Clinical monitoring is recommended Clorazepate extensively metabolised by when co-administering boosted Diazepam CYP3A. Co-administration with darunavir with these Estazolam boosted darunavir may cause a sedatives/hypnotics and a lower dose Flurazepam large increase in the concentration of the sedatives/hypnotics should be Midazolam (parenteral) of these medicines. considered. Zolpidem If parenteral midazolam is co- If parenteral midazolam is co- administered with boosted administered with boosted darunavir, darunavir it may cause a large it should be done in an intensive care increase in the concentration of this unit (ICU) or similar setting, which benzodiazepine. Data from ensures close clinical monitoring and concomitant use of parenteral appropriate medical management in midazolam with other protease case of respiratory depression and/or inhibitors suggest a possible 3-4 prolonged sedation. Dose adjustment fold increase in midazolam plasma for midazolam should be considered, levels. especially if more than a single dose of midazolam is administered.

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): tadalafil (HOS-086316) protease (HOS-085623) estazolam (HOS-086165) clorazepate (HOS-086164) diazepam (HOS-085904) zolpidem (HOS-086327) buspirone (HOS-086325) sildenafil (HOS-086162) flurazepam (HOS-086166) midazolam (HOS-086167) omeprazole (HOS-085912)