Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-132828 · Präparat HOS-097310

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - Hypersensitivity to any imidazole antifungal medicinal product; - Acute or chronic liver disease and/or if pre-treatment liver enzymes levels are above 2 times the upper limit of normal (see sections 4.2 and 4.4): - Pregnancy (see section 4.6); - Breastfeeding (see section 4.6); - Congenital or documented acquired QTc prolongation ; - Concomitant therapy with any of the following medicinal products which may interact and result in potentially life-threatening adverse reactions (see section 4.5): o CYP3A4 metabolised HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin and lovastatin) due to an increased risk of skeletal muscle toxicity including rhabdomyolysis; o eplerenone due to an increased risk of hyperkalemia and hypotension; o substances that may have their plasma concentrations increased and have QT prolonging potential: methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran due to an increased bleeding risk; o triazolam, oral midazolam and alprazolam due to potential for prolonged or increased sedation and respiratory depression; o ergot alkaloids (eg dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) due to an increased risk of ergotism and other serious vasospastic adverse reactions; o lurasidone; o quetiapine due to an increased risk of toxicity; o telithromycin and clarithromycin in patients with severe renal impairment due to an increased risk of hepatotoxicity and QT interval prolongation; o felodipine, nisoldipine due to an increased risk of oedema and congestive heart failure;

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) quetiapine (HOS-086150) methylergonovine (HOS-086155) dronedarone (HOS-086144) methadone (HOS-086198) lovastatin (HOS-086157) eplerenone (HOS-089050) atorvastatin (HOS-086304) felodipine (HOS-108908) alprazolam (HOS-086171) halofantrine (HOS-085606) simvastatin (HOS-086158) quinidine (HOS-085593) dabigatran (HOS-112096) ergot alkaloids (HOS-108807) imidazole (HOS-117862) disopyramide (HOS-085595) telithromycin (HOS-084523) saquinavir (HOS-084522) clarithromycin (HOS-084517) pimozide (HOS-085600) nisoldipine (HOS-114251) ergotamine (HOS-086154) ritonavir (HOS-084521) lurasidone (HOS-086148) ranolazine (HOS-086141) ergonovine (HOS-086153) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167) mizolastine (HOS-085609)