Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUDARABINE PHOSPHATE
AVENTIS PHARMA - Indonesia
FLUDARABINE PHOSPHATE
10 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 5 TABLET SALUT SELAPUT
DELPHARM LILLE SAS - France
2021-10-21
Fludara/Fludarabine phosphate 10 mg/Film coated tablets 1 Important information, please read carefully! COMPOSITION EACH FILM-COATED TABLET CONTAINS 10 MG FLUDARABINE PHOSPHATE. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antineoplastic agents, purine analogues ATC code: L01B B05 Fludara contains fludarabine phosphate, a fluorinated nucleotide analogue of the antiviral agent vidarabine, 9-ß-D- arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine phosphate is rapidly dephosphorylated to 2F-ara-A which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2F-ara-ATP. This metabolite has been shown to inhibit ribonucleotide reductase, DNA polymerase , and , DNA primase and DNA ligase thereby inhibiting DNA synthesis. Furthermore, partial inhibition of RNA polymerase II and consequent reduction in protein synthesis occur. While some aspects of the mechanism of action of 2F-ara-ATP are as yet unclear, it is assumed that effects on DNA, RNA and protein synthesis all contribute to inhibition of cell growth with inhibition of DNA synthesis being the dominant factor. In addition, in vitro studies have shown that exposure of CLL lymphocytes to 2F-ara-A triggers extensive DNA fragmentation and cell death characteristic of apoptosis. PHARMACOKINETIC PROPERTIES PLASMA AND URINARY PHARMACOKINETICS OF FLUDARABINE (2F-ARA-A) The pharmacokinetics of fludarabine (2F-ara-A) has been studied after intravenous administration by rapid bolus injection, short-term infusion and following continuous infusion as well as after peroral dosing of fludarabine phosphate (Fludara, 2F- ara-AMP). • Distribution and metabolism 2F-ara-AMP is a water-soluble prodrug of fludarabine (2F-ara-A), which is rapidly and quantitatively dephosphorylated in the human organism to the nucleoside fludarabine (2F-ara-A). After single dose infusion of 25 mg 2F-ara-AMP per m² to CLL patients for 30 Baca dokumen lengkapnya