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)

Gegenanzeigen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.3 · PDF-Seite 4–5

HOS-132835 · Präparat HOS-097310

4  o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions; o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”.

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): solifenacin (HOS-116433) tolvaptan (HOS-109429) ombitasvir (HOS-110300) colchicine (HOS-086147) everolimus (HOS-086310) fesoterodine (HOS-116432) sirolimus (HOS-085172) ritonavir (HOS-084521) paritaprevir (HOS-110301) irinotecan (HOS-112102) vardenafil (HOS-086163)

Gegenanzeigen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-132840 · Präparat HOS-097310

The list above is not an inclusive list of compounds that may interact with ketoconazole and result in potentially life-threatening reactions.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132841 · Präparat HOS-097310

Concomitant therapy with medicinal products that are contraindicated during treatment with ketoconazole and resulting in potentially life-threatening adverse reactions :

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132842 · Präparat HOS-097310

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 reactionsevents 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; o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”.

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) solifenacin (HOS-116433) 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) tolvaptan (HOS-109429) ergot alkaloids (HOS-108807) disopyramide (HOS-085595) telithromycin (HOS-084523) saquinavir (HOS-084522) ombitasvir (HOS-110300) clarithromycin (HOS-084517) pimozide (HOS-085600) nisoldipine (HOS-114251) colchicine (HOS-086147) everolimus (HOS-086310) fesoterodine (HOS-116432) sirolimus (HOS-085172) ergotamine (HOS-086154) ritonavir (HOS-084521) paritaprevir (HOS-110301) lurasidone (HOS-086148) ranolazine (HOS-086141) irinotecan (HOS-112102) ergonovine (HOS-086153) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167) mizolastine (HOS-085609) vardenafil (HOS-086163)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132843 · Präparat HOS-097310

The list above is not an inclusive list of compounds that may interact with ketoconazole and result in potentially life-threatening reactions.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132844 · Präparat HOS-097310

Medicinal products affecting the absorption of ketoconazole

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132845 · Präparat HOS-097310

Medicinal products affecting gastric acidity impair the absorption of ketoconazole (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132846 · Präparat HOS-097310

Effects of other medicinal products on the metabolism of ketoconazole

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-132847 · Präparat HOS-097310

Ketoconazole is mainly metabolised by cytochrome CYP3A4. Enzyme-inducing medicinal products such as rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine, mitotane and phenytoin may significantly reduce the bioavailability of ketoconazole. Use of ketoconazole with potent enzyme inducers is not recommended.

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): carbamazepine (HOS-085618) rifabutin (HOS-086262) mitotane (HOS-112479) nevirapine (HOS-088064) isoniazid (HOS-088590) phenytoin (HOS-084531)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-132849 · Präparat HOS-097310

7 Potent inhibitors of CYP3A4 (e.g. antivirals such as ritonavir, ritonavir-boosted darunavir and ritonavir- boosted fosamprenavir) may increase the bioavailability of ketoconazole, these medicinal products should be used with caution when co-administered with ketoconazole and patients should be monitored closely for signs and symptoms of adrenal insuficiency. Ketoconazole dose should be adjusted accordingly.

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): darunavir (HOS-086181) fosamprenavir (HOS-086182) ritonavir (HOS-084521)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

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

HOS-132850 · Präparat HOS-097310

Effects of ketoconazole on the metabolism of the other medicinal products

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

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

HOS-132851 · Präparat HOS-097310

- Ketoconazole is a potent inhibitor of CYP3A4 and can inhibit the metabolism of medicinal products metabolised by this enzyme. This can result in an increase and/or prolongation of their effects, including adverse reactions. - In vitro data indicate that ketoconazole is an inhibitor of CYP1A2 and does not significantly inhibit CYP 2A6 and 2E1. At clinically relevant concentrations inhibition of CYP2B6, 2C9/C8, 2C19 and 2D6 by ketoconazole cannot be excluded. - Ketoconazole can inhibit the transport of medicinal products by P-gp, which may result in an increased plasma concentration of these medicinal products. - Ketoconazole inhibits BCRP (Breast Cancer Resistance Protein) in in vitro studies. Data of inhibition indicate that risk of interaction with BCRP substrates cannot be excluded at the systemic level with very high doses of ketoconazole. However, ketoconazole may be an inhibitor of BCRP at the intestinal level at clinically relevant concentrations. Considering the rapid absorption of ketoconazole, intake of BCRP substrates should be postponed for 2 hours after ketoconazole intake.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

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

HOS-132852 · Präparat HOS-097310

Table 1 Interactions and recommendations for co-administration.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

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

HOS-132853 · Präparat HOS-097310

Interactions between ketoconazole and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, an no change as “↔”). The degrees of interaction mentioned below are not absolute values and may be dependent on the ketoconazole dose given, i.e. many results are reported following a ketoconazole dose of 200 mg and a stronger interaction may be expected at a higher dose and/or shorter dosing interval. The following list is not an inclusive list of interactions between ketoconazole and other medicinal products

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

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

HOS-132854 · Präparat HOS-097310

Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Analgesic opioid Methadone Potential ↑ in plasma concentrations of Contraindicated due to the increased methadone risk of serious cardiovascular events including QT prolongation and torsade de pointes, or respiratory or CNS depression (see section 4.3). Buprenorphine IV and Buprenorphine: Careful monitoring. sublingual AUC: ↑ 1.5-fold The buprenorphine dose should be Cmax: ↑1.7-fold adjusted. Alfentanil, fentanyl Potential ↑in plasma concentrations of Careful monitoring of adverse alfentanil and fentanyl reactions (respiratory depression, sedation) is recommended. It may be necessary to lower the dose of alfentanil and fentanyl. Oxycodone ↑in plasma concentrations of oxycodone Careful monitoring. have been observed The oxycodone dose may be adjusted. Antiarrhythmics Disopyramide Potential ↑in plasma concentrations of Contraindicated due to the risk of Quinidine disopyramide and quinidine serious cardiovascular events including QT prolongation (see Dronedarone Repeated doses of 200 mg ketoconazole section 4.3). daily resulted in a 17-fold increase in dronedarone exposure

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): alfentanil (HOS-109375) dronedarone (HOS-086144) methadone (HOS-086198) oxycodone (HOS-109487) quinidine (HOS-085593) buprenorphine (HOS-086193) disopyramide (HOS-085595) fentanyl (HOS-086196)

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)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-132857 · Präparat HOS-097310

9 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Telithromycin Telithromycine: Not recommended. Clarithromycin AUC: ↑ 2-fold Contraindicated in patients with Cmax: ↑1.5-fold severe renal impairment due to the Potential ↑in plasma concentrations of risk of QT interval prolongation and clarithromycin serious hepatic adverse reactions (see section 4.3). Isavuconazole AUC: ↑ 5-fold Not recommended due to increased Cmax: ↑ 1.1 -fold risk of isavuconazole adverse reactions, please consult isavuconazole SmPC Praziquantel ↑in plasma concentrations of Careful monitoring. praziquantel have been observed Dose adjustment of praziquantel may be required. Antimigraine Drugs Ergots alkaloids such as Potential ↑in plasma concentrations of Contraindicated due to the increased dihydroergotamine, ergot alkaloids risk of ergotism and other serious ergometrine vasospastic adverse reactions (see (ergonovine), section 4.3). ergotamine, methylergometrine (methylergonovine) Eletriptan Eletriptan: Not recommended. AUC: ↑ 5.9-fold Cmax: ↑ 2.7-fold Antineoplastics Irinotecan Irinotecan: Contraindicated due to an alteration AUC: ↑ 2.1-fold of the metabolism of this medicinal product (see section 4.3). Sunitinib Sunitinib Not recommended due to the risk of Dasatinib AUC: ↑ 1.5-fold increased exposure to these medicinal Lapatinib Cmax: ↑ 1.5-fold products and QT prolongation. Nilotinib Lapatinib: Erlotinib AUC: ↑ 3.6-fold Dabrafenib Nilotinib: Cabozantinib AUC: ↑ 3.0-fold Erlotinib: AUC: ↑ 1.9-fold Cmax: ↑ 1.7-fold Dasatinib ↑in plasma concentrations of Dasatinib have been observed Dabrafenib AUC: ↑ 1.7-fold Cmax: ↑ 1.3-fold Cabozantinib AUC: ↑ 1.4-fold Cmax: ↔ Ibrutinib Ibrutinib: Not recommended as it may increase AUC: ↑ 24-fold ibrutinib-related toxicity. Cmax: ↑ 29-fold

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): praziquantel (HOS-132858) dasatinib (HOS-086217) isavuconazole (HOS-085186) methylergonovine (HOS-086155) dabrafenib (HOS-109452) ergot alkaloids (HOS-108807) telithromycin (HOS-084523) lapatinib (HOS-122565) clarithromycin (HOS-084517) erlotinib (HOS-113527) eletriptan (HOS-132859) sunitinib (HOS-109453) ergotamine (HOS-086154) irinotecan (HOS-112102) ergonovine (HOS-086153) cabozantinib (HOS-109450) nilotinib (HOS-086218) dihydroergotamine (HOS-086152) ibrutinib (HOS-086226)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 10–11

HOS-132860 · Präparat HOS-097310

10 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Crizotinib Crizotinib Not recommended due to the risk of AUC: ↑ 3.2-fold QT interval prolongation and serious Cmax: ↑ 1.4-fold hepatic adverse reactions.

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): crizotinib (HOS-116818)

Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-132861 · Präparat HOS-097310

Monitoring of QT-prolongation if used concomitantly. Bortezomib Bortezomib: Careful monitoring. Busulfan AUC: ↑ 1.4-fold Dose adjustment of each medicinal Docetaxel Imatinib: product may be required. Imatinib AUC: ↑ 1.4-fold Cabazitaxel Cmax: ↑ 1.3-fold ↑in plasma concentrations of docetaxel have been observed Potential ↑in plasma concentrations of busulfan Cabazitaxel AUC: ↑ 1.3-fold Paclitaxel Paclitaxel: Careful monitoring. No change in plasma concentration were Dose adjustment of paclitaxel shown with paclitaxel concentrate. No may be required. studies were performed with albumin bound nanoparticules. Vincristine, vinblastine Potential ↑in plasma concentrations of Careful monitoring as it may cause (vinca alkaloids) vinca alkaloids. an earlier onset and/or an increased severity of side-effects. Antipsychotics, Anxiolytics and Hypnotics Triazolam AUC: ↑ have been observed Contraindicated due to the risk of Alprazolam Cmax: ↑ have been observed potentially prolonged or increased Midazolam oral sedation and respiratory depression (see section 4.3). Lurasidone Lurasidone: Contraindicated due to the increased AUC: ↑ 9 fold risk of adverse reactions (see section Cmax: ↑ 6 fold 4.3). Pimozide Potential ↑in plasma concentrations of Contraindicated due to the risk of pimozide. serious cardiovascular events including QT prolongation (see section 4.3). Sertindole Potential ↑in plasma concentrations of Contraindicated due to the risk of QT sertindole. prolongation (see section 4.3). Quetiapine Quetiapine: Contraindicated as it may increase AUC: ↑ 6.2-fold quetiapine-related toxicity (see Cmax: ↑ 3.4-fold section 4.3). Haloperidol Potential ↑in plasma concentrations of Not recommended due to the haloperidol. increased risk of QT prolongation and extrapyramidal symptoms. It may be necessary to reduce haloperidol dosage. Reboxetine Reboxetine: Not recommended because of AUC: ↑ 1.5-fold of both enantiomers reboxetine narrow’s therapeutic margin. Midazolam IV Midazolam: Careful monitoring. AUC: ↑ 1.6-fold Dose adjustment of midazolam IV may be required. 11 Medicinal product by Expected effect on drug levels Recommendation for co- therapeutic area administration Buspirone Potential ↑in plasma concentrations of Careful monitoring. buspirone. Dose adjustement of buspirone may be required. Aripiprazole Aripiprazole Careful monitoring. AUC: ↑ 1.6-fold Aripiprazole dose should be reduced Cmax: ↑ 1.4-fold to approximatively one-half of its prescribed dose. Risperidone Potential ↑in AUC of risperidone: Careful monitoring. Dose adjustment of risperidone may be required. Antivirals products Saquinavir Saquinavir: Contraindicated due to the risk of QT (saquinavir/ritonavir AUC: ↔ prolongation (see section 4.3). 1000/100 mg bid) Cmax: ↔ Ketoconazole AUC: ↑ 2.7-fold Cmax:↑ 1.5-fold (CYP3A4 enzyme inhibition by ritonavir) Paritaprevir: Contraindicated due to the increased AUC: ↑2.2-fold risk of adverse reactions (see section Cmax: ↑1.7-fold 4.3).

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): aripiprazole (HOS-129408) sertindole (HOS-085601) quetiapine (HOS-086150) busulfan (HOS-115553) reboxetine (HOS-132863) alprazolam (HOS-086171) vinblastine (HOS-086220) risperidone (HOS-086280) vincristine (HOS-086219) imatinib (HOS-110212) docetaxel (HOS-084505) saquinavir (HOS-084522) bortezomib (HOS-110227) pimozide (HOS-085600) cabazitaxel (HOS-124028) buspirone (HOS-086325) paclitaxel (HOS-087959) haloperidol (HOS-085602) ritonavir (HOS-084521) paritaprevir (HOS-110301) lurasidone (HOS-086148) triazolam (HOS-086168) midazolam (HOS-086167)