FLUDARA

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

FLUDARABINE PHOSPHATE

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

FLUDARABINE PHOSPHATE

Dosis:

10 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 4 BLISTER @ 5 TABLET SALUT SELAPUT

Diproduksi oleh:

DELPHARM LILLE SAS - France

Tanggal Otorisasi:

2021-06-17

Karakteristik produk

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