Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 8–9

HOS-132855 · Präparat HOS-097310

8 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Digoxin Potential ↑in plasma concentrations of Careful monitoring of digoxin levels digoxine is recommended. Anticoagulants and antiplatelet drugs Dabigatran Dabigatran: Contraindicated due to an increased AUC: ↑ 2.6-fold bleeding risk (see section 4.3). Cmax: ↑2.5-fold Rivaroxaban Rivaroxaban: Not recommended due to an AUC: ↑ 2.6-fold increased bleeding risk. Cmax: ↑1.7-fold Apixaban Apixaban Not recommended due to an AUC: ↑ 2-fold increased bleeding risk. Cmax: ↑1.6-fold Cilostazol Cilostazol: Careful monitoring AUC: ↑ 2.2 fold A cilostazol dose of 50 mg twice daily is recommended in combination The overall pharmacological activity of with ketoconazole. cilostazol increases 35% when co- administered with ketoconazole. Warfarin and other Potential ↑in plasma concentrations of Careful monitoring coumarin-like drugs warfarin INR (international normalised ratio) monitoring recommended. Edoxaban AUC: ↑ 1.8-fold Dose of edoxaban needs to be Cmax: ↑ 1.8-fold reduced when used concomitantly, please consult edoxaban SmPC. Anticonvulsants Carbamazepine Potential ↑in plasma concentrations of Not recommended. Phenytoin carbamazepine and phenytoin (See also “Effects of other medicinal products on the metabolism of Potential ↓ in plasma concentrations of Ketoconazole Esteve ”). ketoconazole are expected. (CYP3A enzyme induction) Antidiabetics Repaglinide Repaglinide: Careful monitoring. AUC: ↑ 1.2-fold Dose adjustement of repaglinide may Cmax: ↑ 1.2-fold be required. Saxagliptin Saxagliptin: Careful monitoring. AUC: ↑ 2.5-fold Dose adjustment of saxagliptin may Cmax: ↑ 1.6-fold be required. Associated with a decrease in corresponding values for the active metabolite Tolbutamide Tolbutamide: Careful monitoring. AUC: ↑ 1.7-fold Dose adjustment of tolbutamide may be required. Anti-infectives Rifabutin Potential ↑ in plasma concentrations of Not recommended. (See also “Effects Rifampicin rifabutine. of other medicinal products on the Isoniazid Potencial ↓ in plasma concentrations of metabolism of Ketoconazole Esteve ketoconazole are expected. ”) (CYP3A4 enzyme induction)

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): cilostazol (HOS-111550) saxagliptin (HOS-121455) carbamazepine (HOS-085618) rifabutin (HOS-086262) digoxin (HOS-086172) dabigatran (HOS-112096) rivaroxaban (HOS-086236) edoxaban (HOS-086234) apixaban (HOS-112091) isoniazid (HOS-088590) phenytoin (HOS-084531) warfarin (HOS-085950) repaglinide (HOS-086935) tolbutamide (HOS-086568)