Contraindications : התוויות נגד

4.3     Contraindications

-     Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 -     Hypersensitivity to any imidazole antifungal medication 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 (e.g. 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 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”.


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