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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile MedicinalProductInteraction.
Generated Narrative with Details
id: example
description: Inhibitors of CYP3A4 and P-gp\nCoadministration of equixaban with ketoconazole (400 mg once a day), a strong inhibitor of both\nCYP3A4 and P-gp, led to a 2-fold increase in mean equixaban AUC and a 1.6-fold increase in mean\nequixaban Cmax.\nThe use of Eliquis is not recommended in patients receiving concomitant systemic treatment with\nstrong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole,\nitraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir) (see\nsection 4.4).\nActive substances which are not considered strong inhibitors of both CYP3A4 and P-gp,\n(e.g., diltiazem, naproxen, amiodarone, verapamil, quinidine) are expected to increase equixaban\nplasma concentration to a lesser extent. Diltiazem (360 mg once a day), for instance, considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase in mean equixaban AUC and a 1.3-fold increase in Cmax. Naproxen (500 mg, single dose) an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase in mean equixaban AUC and Cmax, respectively. No dose adjustment for equixaban is required when coadministered with less potent inhibitors of CYP3A4 and/or P-gp.
interactant
item: ketoconazole (Details : {http://ema.europa.eu/example/interactant code 'ketoconazole' = 'ketoconazole)
interactant
item: itraconazole (Details : {http://ema.europa.eu/example/interactant code 'itraconazole' = 'itraconazole)
type: StrongInhibitorofCYP3A4 (Details : {http://ema.europa.eu/example/interactionsType code 'StrongInhibitorofCYP3A4' = 'StrongInhibitorofCYP3A4)
effect: Increasedplasmaconcentrations (Details : {http://ema.europa.eu/example/interactionseffect code 'Increasedplasmaconcentrations' = 'Increasedplasmaconcentrations)
management: Coadministration not recommended in patients receiving concomitant systemic treatment strong inhibitors of both CYP3A4 and P-gp (Details )
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.