At the last visit, 78 patients (49.3%) were controlled, 37 patients (23.4%) had partial control with at least 50% decrease of UFC (without normalisation), and 43 patients (27.2%) had unchanged UFC levels. In case of adrenal insufficiency, Ketoconazole HRA treatment should be temporarily discontinued or the dose reduced and, if needed, a corticosteroid substitution therapy added. Serum or plasma and/or salivary cortisol and/or urinary free cortisol levels should be monitored, within one week following Ketoconazole HRA initiation as a minimum, and then periodically thereafter. No formal evaluation of the effect of age on the pharmacokinetics of Ketoconazole HRA has been performed.
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gesetzl. Consistent with the pharmacological action of ketaconazole, effects were observed on adrenal and gonads in rats and dogs.Elevated liver enzymes and histological changes in the liver consisting in dose–related lipofuscin accumulation in hepatocytes were reported in rats and dogs after repeated administration of ketoconazole.Electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QT interval. The SmPC for concomitantly used products must be consulted for the recommendations regarding co-administration with strong CYP3A4 inhibitors.Ketoconazole HRA is a potent inhibitor of CYP3A4: inhibition of CYP3A4 by Ketoconazole HRA can increase patients' exposure to a number of medicinal products which are metabolised through this enzymatic system (see section 4.5).Ketoconazole HRA is also a potent inhibitor of P-gp: inhibition of P-gp by Ketoconazole HRA can increase patients' exposure to medicinal products which are P-gp substrates (see section 4.5).CYP3A4-metabolised and/or P-gp substrates known to prolong the QT interval may be contraindicated with Ketoconazole HRA, since the combination may lead to an increased risk of ventricular tachyarrhythmias, including occurrences of torsade de pointes, a potentially fatal arrhythmia (see section 4.3).Co-administration of Ketoconazole HRA and other medications known to have potentially hepatotoxic effect (eg paracetamol) is not recommended since the combination may lead to increased risk of liver damage.Co-administration of Ketoconazole HRA and pasireotide is not recommended since the combination can lead to QT prolongation in patients with known cardiac rhythm disorders (see section 4.5).Exacerbation or development of inflammatory/autoimmune disorders has been described after Cushing's syndrome remission, including after treatment with ketoconazole. Ketoconazole tersedia dalam bentuk krim 2%, tablet 200 mg, dan sampo. ↑in plasma concentrations of oxycodone have been observedPotential ↑in plasma concentrations of disopyramide and quinidine Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposureContraindicated due to the risk of serious cardiovascular events including QT prolongation (see section 4.3). Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption.
Bei welchen Erkrankungen wird das Arzneimittel angewendet?Wie oft und in welcher Menge wird das Arzneimittel angewendet?In welchen Fällen darf das Arzneimittel nicht angewendet werden?Welche Nebenwirkungen können bei einzelnen Patienten auftreten?Welche Wechselwirkungen mit anderen Arzneimitteln können auftreten?
If these occur, treatment should be stopped immediately and liver function tests should be performed.Due to the known hepatotoxicity of ketoconazole, the treatment must not be initiated in patients with liver enzymes levels above 2 times the upper limit of normal (see section 4.3).- measurement of liver enzymes (ASAT, ALAT, gamma GT and alkaline phosphatase) and bilirubin, should be performed at frequent intervals: o weekly for one month after initiation of the treatment o weekly during one month whenever the dose was increased.