Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EDOXABEN TOSYLATE
KALBE FARMA - Indonesia
EDOXABEN TOSYLATE
15 MG
TABLET SALUT SELAPUT
DUS, 7 BLISTER @ 14 TABLET SALUT SELAPUT
DAICHI SANKYO EUROPE GmbH - Germany
2018-10-15
1 LIXIANA Compositions Each film-coated tablet contains: Edoxaban..................................................................................................................15 mg Edoxaban..................................................................................................................30 mg Edoxaban..................................................................................................................60 mg PHARMACOLOGY MECHANISM OF ACTIONS Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade. Edoxaban inhibits free factor Xa, and prothrombinase activity. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation. Pharmacodynamic effects Edoxaban produces rapid onset of pharmacodynamic effects within 1-2 hours, which corresponds with peak edoxaban exposure (Cmax). The pharmacodynamic effects measured by anti-factor Xa assay are predictable and correlate with the dose and the concentration of edoxaban. As a result of FXa inhibition, edoxaban also prolongs clotting time in tests such as prothrombin time (PT), and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests are expected at the therapeutic dose, however, these changes are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of edoxaban. PHARMACOKINETICS _Absorption _ Edoxaban is absorbed with peak plasma concentrations within 1-2 hours. The absolute bioavailability is approximately 62%. Food increases peak exposure to a varying extent, but has minimal effect on total exposure. Edoxaban was administered with or without food in the ENGAGE AF-TIMI 48 and the Hokusai-VTE studies. Edoxaban is poorly soluble at pH of 6.0 or higher. Co-administration of proton-pump inhibitors had no relevant impact on edoxaban exposure. _Distribution _ Disposition is biphasic. Läs hela dokumentet