Zum Inhalt

HealthOSArzneimittel

Arbeitsbereiche

Nachschlagen

Wirkstoffe & Arzneimittelsicherheit

Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.

Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.

RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.

Quellenpassagen (66)

Wechselwirkungen · Pradaxa

Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-118632 · Präparat HOS-094855

Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily. Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg. Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected. cyclosporine Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b497c2d17a671eadd6d3621f31894d932a018ff0cc8853d598c918ee52245e3c · Zeichen 637–1725 im Abschnitt

Wechselwirkungen · Pradaxa

Pradaxa 110 mg hard capsules · Abschnitt 4.5 · PDF-Seite 44

HOS-118708 · Präparat HOS-094855

Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily. Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg. Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected. cyclosporine Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 638–1714 im Abschnitt

Wechselwirkungen · Pradaxa

Pradaxa 150 mg hard capsules · Abschnitt 4.5 · PDF-Seite 84

HOS-118796 · Präparat HOS-094855

Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily. Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg. Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected. cyclosporine Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 638–1714 im Abschnitt

Wechselwirkungen · Pradaxa

Pradaxa 20 mg coated granules Pradaxa 30 mg coated granules Pradaxa 40 mg coated granules Pradaxa 50 mg coated granules Pradaxa 110 mg coated granules Pradaxa 150 mg coated granules · Abschnitt 4.5 · PDF-Seite 118

HOS-118883 · Präparat HOS-094855

Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and 2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and 2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once daily. Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg. Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected. cyclosporine Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b000b61f23f21217cd1eeb72ccdd6aefcf2bf6361ee5c839ed6c379c8e124d16 · Zeichen 680–1756 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 2.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-120047 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2405–2518 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 35

HOS-120080 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2461–2574 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 15 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 62

HOS-120111 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2685–2798 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 94

HOS-120143 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2685–2798 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 124

HOS-120174 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2463–2576 im Abschnitt

Wechselwirkungen · Xarelto

Xarelto 1 mg/mL granules for oral suspension · Abschnitt 4.5 · PDF-Seite 149

HOS-120205 · Präparat HOS-095079

Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.

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): dronedarone (HOS-086144)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-09-22T13:29:00Z · SHA-256 296cd19bd9d543e8a553e31f26d947abea5c7cc81862818289ca4c4ece9a3aa9 · Passage dc21fecd97ab456e244117d2d84aa8aa567585d47cafea2c505cb1abd4202d39 · Zeichen 2685–2798 im Abschnitt

Wechselwirkungen · Afinitor

Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-210305 · Präparat HOS-154501

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Afinitor (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when (range 2.0-12.6) co-administration of moderate Cmax ↑2.0-fold CYP3A4 inhibitors or PgP (range 0.9-3.5) inhibitors cannot be avoided. If Imatinib AUC ↑ 3.7-fold patients require co-administration Cmax ↑ 2.2-fold of a moderate CYP3A4 or PgP Verapamil AUC ↑3.5-fold inhibitor, dose reduction to 5 mg (range 2.2-6.3) daily or 2.5 mg daily may be Cmax ↑2.3-fold considered. However, there are no (range1.3-3.8) clinical data with this dose Ciclosporin oral AUC ↑2.7-fold adjustment. Due to between (range 1.5-4.7) subject variability the Cmax ↑1.8-fold recommended dose adjustments (range 1.3-2.6) may not be optimal in all Cannabidiol (PgP inhibitor) AUC ↑2.5-fold individuals, therefore close Cmax ↑2.5-fold monitoring of side effects is Fluconazole Not studied. Increased exposure recommended (see sections 4.2 and Diltiazem expected. 4.4). If the moderate inhibitor is Dronedarone Not studied. Increased exposure discontinued, consider a washout expected. period of at least 2 to 3 days Amprenavir, fosamprenavir Not studied. Increased exposure (average elimination time for most expected. commonly used moderate inhibitors) before the Afinitor dose is returned to the dose used prior to initiation of the co-administration. Grapefruit juice or other Not studied. Increased exposure Combination should be avoided. food affecting CYP3A4/PgP expected (the effect varies widely).

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): indinavir (HOS-084518) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-20T11:21:00Z · SHA-256 678fc33837cd44d2e9320c5c80ffc02496b10803d7810e1b4f6e2d8e517263a0 · Passage 98d9f664e41c1a110308717f9cdec97f696053564a7a56a6d0f4d257ec0e0700 · Zeichen 1007–4534 im Abschnitt

Wechselwirkungen · Signifor

Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-213401 · Präparat HOS-155106

Medicinal products that prolong the QT interval Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also 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): sertindole (HOS-085601) lumefantrine (HOS-114826) sotalol (HOS-085597) dronedarone (HOS-086144) methadone (HOS-086198) fluphenazine (HOS-213409) ketoconazole (HOS-084513) dofetilide (HOS-085598) halofantrine (HOS-085606) ibutilide (HOS-085599) quinidine (HOS-085593) chlorpromazine (HOS-087796) thioridazine (HOS-086281) disopyramide (HOS-085595) procainamide (HOS-086617) clarithromycin (HOS-084517) amisulpride (HOS-087798) pimozide (HOS-085600) erythromycin (HOS-084514) moxifloxacin (HOS-085604) astemizole (HOS-085608) pentamidine (HOS-085605) haloperidol (HOS-085602) amiodarone (HOS-085596) terfenadine (HOS-085607) tiapride (HOS-087799) chloroquine (HOS-109138) mizolastine (HOS-085609)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2024-12-18T10:26:00Z · SHA-256 8d39a4369995f88230d9c38d5acd5d8dc8ac03b6669b211c0130be10866c5ae6 · Passage 993e674cc3557753b51cbd078a1c6936fdf34c610462c4436f89d7e1f9025f1e · Zeichen 677–1481 im Abschnitt

Wechselwirkungen · Signifor

Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection · Abschnitt 4.5 · PDF-Seite 21

HOS-213449 · Präparat HOS-155106

Medicinal products that prolong the QT interval Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also 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): sertindole (HOS-085601) lumefantrine (HOS-114826) sotalol (HOS-085597) dronedarone (HOS-086144) methadone (HOS-086198) fluphenazine (HOS-213409) ketoconazole (HOS-084513) dofetilide (HOS-085598) halofantrine (HOS-085606) ibutilide (HOS-085599) quinidine (HOS-085593) chlorpromazine (HOS-087796) thioridazine (HOS-086281) disopyramide (HOS-085595) procainamide (HOS-086617) clarithromycin (HOS-084517) amisulpride (HOS-087798) pimozide (HOS-085600) erythromycin (HOS-084514) moxifloxacin (HOS-085604) astemizole (HOS-085608) pentamidine (HOS-085605) haloperidol (HOS-085602) amiodarone (HOS-085596) terfenadine (HOS-085607) tiapride (HOS-087799) chloroquine (HOS-109138) mizolastine (HOS-085609)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2024-12-18T10:26:00Z · SHA-256 8d39a4369995f88230d9c38d5acd5d8dc8ac03b6669b211c0130be10866c5ae6 · Passage 993e674cc3557753b51cbd078a1c6936fdf34c610462c4436f89d7e1f9025f1e · Zeichen 734–1538 im Abschnitt

Wechselwirkungen · Dificlir

DIFICLIR 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-213563 · Präparat HOS-155136

Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.4 and 5.2).

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) clarithromycin (HOS-084517) erythromycin (HOS-084514) amiodarone (HOS-085596) cyclosporine (HOS-084512) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2024-09-30T02:00:00Z · SHA-256 959742a7c42d6078ecb8c85078e078e429fa22014919451b98bac25d52c7c281 · Passage f47b6bbe1e365edee37854b52b11fdc85c992c9a1ac178a07dff16a524345c49 · Zeichen 42–635 im Abschnitt

Wechselwirkungen · Dificlir

DIFICLIR 40 mg/ml granules for oral suspension · Abschnitt 4.5 · PDF-Seite 13

HOS-213586 · Präparat HOS-155136

Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).

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): dronedarone (HOS-086144) ketoconazole (HOS-084513) clarithromycin (HOS-084517) erythromycin (HOS-084514) amiodarone (HOS-085596) cyclosporine (HOS-084512) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2024-09-30T02:00:00Z · SHA-256 959742a7c42d6078ecb8c85078e078e429fa22014919451b98bac25d52c7c281 · Passage b59ae59af2b7831e8a72835eab361a0a4e07143198502eb36068061721be3e32 · Zeichen 42–634 im Abschnitt

Wechselwirkungen · Votubia

Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-214256 · Präparat HOS-155312

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Votubia (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when co-administration (range 2.0-12.6) of moderate CYP3A4 inhibitors or Cmax ↑2.0-fold PgP inhibitors cannot be avoided. (range 0.9-3.5) Imatinib AUC ↑ 3.7-fold For patients with renal Cmax ↑ 2.2-fold angiomyolipoma associated with Verapamil AUC ↑3.5-fold TSC: (range 2.2-6.3) If patients require co-administration Cmax ↑2.3-fold of a moderate CYP3A4 or PgP (range1.3-3.8) inhibitor, dose reduction to 5 mg or Ciclosporin oral AUC ↑2.7-fold 2.5 mg daily may be considered. (range 1.5-4.7) However, there are no clinical data Cmax ↑1.8-fold with this dose adjustment. Due to (range 1.3-2.6) between subject variability the Cannabidiol (PgP inhibitor) AUC ↑2.5-fold recommended dose adjustments may Cmax ↑2.5-fold not be optimal in all individuals, Fluconazole Not studied. Increased exposure therefore close monitoring of side Diltiazem expected. effects is recommended. If the Dronedarone Not studied. Increased exposure moderate inhibitor is discontinued, expected. consider a washout period of at least Amprenavir, fosamprenavir Not studied. Increased exposure 2 to 3 days (average elimination time expected. for most commonly used moderate inhibitors) before the Votubia dose is returned to the dose used prior to initiation of the co-administration (see also Therapeutic drug monitoring in section 4.2).

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): indinavir (HOS-084518) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-20T17:40:00Z · SHA-256 252b066ec590fdab1f3eb7eccacdb5c7e91ec79421c970096d1b5261820faba4 · Passage 874bc02290752e0fb541064d49638c0e5fad0c860b7d55032749ccc1bff1dcda · Zeichen 1008–4464 im Abschnitt

Wechselwirkungen · Votubia

Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 38

HOS-214306 · Präparat HOS-155312

Active substance by Interaction – Change in Recommendations concerning interaction Everolimus AUC/Cmax co-administration Geometric mean ratio (observed range) Potent CYP3A4/PgP inhibitors Ketoconazole AUC ↑15.3-fold Concomitant treatment of Votubia (range 11.2-22.5) and potent inhibitors is not Cmax ↑4.1-fold recommended. (range 2.6-7.0) Itraconazole, posaconazole, Not studied. Large increase in voriconazole everolimus concentration is Telithromycin, expected. clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin AUC ↑4.4-fold Use caution when co-administration (range 2.0-12.6) of moderate CYP3A4 inhibitors or Cmax ↑2.0-fold PgP inhibitors cannot be avoided. (range 0.9-3.5) Imatinib AUC ↑ 3.7-fold If patients require co-administration Cmax ↑ 2.2-fold of a moderate CYP3A4 or PgP Verapamil AUC ↑3.5-fold inhibitor, reduce the daily dose by (range 2.2-6.3) approximately 50%. Further dose Cmax ↑2.3-fold reduction may be required to manage (range1.3-3.8) adverse reactions (see sections 4.2 Ciclosporin oral AUC ↑2.7-fold and 4.4). Everolimus trough (range 1.5-4.7) concentrations should be assessed at Cmax ↑1.8-fold least 1 week after the addition of a (range 1.3-2.6) moderate CYP3A4 or PgP inhibitor. Cannabidiol (PgP inhibitor) AUC ↑2.5-fold If the moderate inhibitor is Cmax ↑2.5-fold discontinued, consider a washout Fluconazole Not studied. Increased exposure period of at least 2 to 3 days Diltiazem expected. (average elimination time for most Dronedarone Not studied. Increased exposure commonly used moderate inhibitors) expected. before the Votubia dose is returned Amprenavir, fosamprenavir Not studied. Increased exposure to the dose used prior to initiation of expected. the co-administration. The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4). Grapefruit juice or other Not studied. Increased exposure Combination should be avoided. food affecting CYP3A4/PgP expected (the effect varies widely).

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): indinavir (HOS-084518) diltiazem (HOS-086288) nefazodone (HOS-084519) atazanavir (HOS-086180) nelfinavir (HOS-084520) dronedarone (HOS-086144) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) cannabidiol (HOS-090609) imatinib (HOS-110212) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) saquinavir (HOS-084522) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521) posaconazole (HOS-085622) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-11-20T17:40:00Z · SHA-256 252b066ec590fdab1f3eb7eccacdb5c7e91ec79421c970096d1b5261820faba4 · Passage ddc95e209a3f4d8e5376fa36e344d27d483981c2f805f567ef2fb4a51b8f3e0c · Zeichen 1012–4524 im Abschnitt

Gegenanzeigen · Lojuxta

Lojuxta 2 mg hard capsules Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules · Abschnitt 4.3 · PDF-Seite 5–6

HOS-127350 · Präparat HOS-096397

5 • Concomitant use of Lojuxta with strong or moderate CYP3A4 inhibitors (e.g. antifungal azoles such as itraconazole, fluconazole,ketoconazole, voriconazole, posaconazole; macrolide antibiotics such as erythromycin or clarithromycin; ketolide antibiotics such as telithromycin; human immunodeficiency virus (HIV) protease inhibitors; the calcium channel blockers diltiazem and verapamil, and the anti-arrhythmic dronedarone [see section 4.5]). • Pregnancy (see section 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): diltiazem (HOS-086288) dronedarone (HOS-086144) protease (HOS-085623) ketoconazole (HOS-084513) calcium (HOS-085615) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) posaconazole (HOS-085622) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-06-25T14:24:00Z · SHA-256 56c36935b5cda4380e359902f1acbc5ec5bb081beeb96ca75e5ad86521fcd98c · Passage d1a615988ceef3f41eccdcddf2bc16d1d15b751ee1b63121323cddc7b93c7452 · Zeichen 504–1012 im Abschnitt

Wechselwirkungen · Lojuxta

Lojuxta 2 mg hard capsules Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules · Abschnitt 4.5 · PDF-Seite 10

HOS-127353 · Präparat HOS-096397

Table 3: Interactions between lomitapide and other medicinal products and other forms of interaction Medicinal Effects on lomitapide levels Recommendation concerning products co-administration with lomitapide Inhibitors of Strong and moderate inhibitors Strong and moderate inhibitors CYP3A4 When lomitapide 60 mg was Use of strong or moderate inhibitors of co-administered with ketoconazole CYP3A4 is contraindicated with Lojuxta. If 200 mg twice daily, a strong treatment with antifungal azoles (e.g. inhibitor of CYP3A4, lomitapide itraconazole, ketoconazole, fluconazole, area under the curve (AUC) voriconazole, posaconazole); the increased approximately 27-fold and antiarrhythmic dronedarone; macrolide maximum plasma concentration antibiotics (e.g. erythromycin, (Cmax) increased approximately clarithromycin); ketolide antibiotics (e.g. 15-fold. telithromycin); HIV protease inhibitors; the calcium channel blockers diltiazem and Interactions between moderate verapamil is unavoidable, therapy with CYP3A4 inhibitors and lomitapide Lojuxta should be suspended during the have not been studied. course of treatment (see sections 4.3 and 4.4). Moderate CYP3A4 inhibitors are predicted to have a substantial Grapefruit juice is a moderate inhibitor of impact on lomitapide CYP3A4 and is expected to substantially pharmacokinetics. Concomitant use increase exposure to lomitapide. Patients of moderate CYP3A4 inhibitors are taking Lojuxta should avoid consumption of expected to increase lomitapide grapefruit juice. exposure by 4-10 fold based on the results of the study with the strong CYP3A4 inhibitor ketoconazole and on historical data for the model CYP3A4 probe midazolam.

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): diltiazem (HOS-086288) dronedarone (HOS-086144) protease (HOS-085623) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) calcium (HOS-085615) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) posaconazole (HOS-085622) midazolam (HOS-086167) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2026-06-25T14:24:00Z · SHA-256 56c36935b5cda4380e359902f1acbc5ec5bb081beeb96ca75e5ad86521fcd98c · Passage 852fb3071d15cfb76a8df59bf01a4b218ea890f9df6fe33e79bcb064e54c8028 · Zeichen 82–2545 im Abschnitt

Wechselwirkungen · Lixiana

Lixiana 15 mg film-coated tablets Lixiana 30 mg film-coated tablets Lixiana 60 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-127803 · Präparat HOS-096471

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitors ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil resulted in increased plasma concentrations of edoxaban. Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily. Concomitant use of edoxaban with quinidine, verapamil, or amiodarone does not require dose reduction based on clinical data (see section 4.2). The use of edoxaban with other P-gp inhibitors including human immunodeficiency virus (HIV) protease inhibitors has not been studied.

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): dronedarone (HOS-086144) protease (HOS-085623) ketoconazole (HOS-084513) quinidine (HOS-085593) erythromycin (HOS-084514) amiodarone (HOS-085596) verapamil (HOS-090602)

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-08-27T13:11:00Z · SHA-256 5fd1fde6f72bf5d3892ddc2d35b116dd396f6657ffdfad7faca24bdcd927d334 · Passage 6a74087b198ddb5b29fb7a742e89d3cad69035714c3241bb8d7c59b44124da45 · Zeichen 260–959 im Abschnitt

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.