Fytosid Injection (20mgml)

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

ETOPOSIDE

Dostępny od:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Nazwa):

ETOPOSIDE

Sztuk w opakowaniu:

5ml mL

Wyprodukowano przez:

Fresenius Kabi Oncology Limited

Charakterystyka produktu

1
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
ETOPOSIDE INJECTION
FYTOSID INJECTION (20MG/ML)
DESCRIPTION:
A clear, almost colourless to pale yellow, solution, free from visible
particles. The solution after
dilution should appear in clear, almost colourless to pale yellow.
COMPOSITION:
Each ml contains:
Etoposide
20.0 mg
Benzyl Alcohol
30.0 mg
Dehydrated Alcohol
30.5% v/v
CHEMICAL STRUCTURE:
The structural formula of Etoposide is as follows:
The chemical name of etoposide is 4'-demethylepipodophyllotoxin
9-[4,6-O-(R)-ethylidene-β-D-
glucopyranoside].
Molecular formula: C
29
H
32
O
13
Relative molecular mass: 588.56.
PHARMACOLOGY:
MECHANISM OF ACTION
Etoposide
is
a
semisynthetic
derivative
of
podophyllotoxin
used
in
the
treatment
of
certain
neoplastic diseases. Podophyllotoxins inhibit mitosis by blocking
microtubular assembly. Etoposide
inhibits cell cycle progression at a premitotic phase (late S and G2).
It does not interfere with the
synthesis of nucleonic acids.
2
PHARMACOKINETICS
Distribution
The mean volumes of distribution at steady state range from 18 to 29
liters. Etoposide shows low
penetration into the CSF.
_In vitro_
, etoposide is highly protein bound (97%) to human plasma
proteins. Etoposide binding ratio correlates directly with serum
albumin in cancer patients and
normal volunteers. Unbound fraction of etoposide correlates
significantly with bilirubin in cancer
patients.
Following intravenous infusion, the C
max
and AUC values exhibit marked intra- and inter-subject
variability.
Biotransformation
The
hydroxyacid
metabolite
[4'
dimethyl-epipodophyllic
acid-9-(4,6
0-ethylidene-β-D-
glucopyranoside)], formed by opening of the lactone ring, is found in
the urine of adults and
children. It is also present in human plasma, presumably as the trans
isomer. Glucuronide and/or
sulphate conjugates of etoposide are also excreted in human urine. In
addition, O-demethylation of
the dimethoxy phenol ring occurs through the CYP450 3A4 isoenzyme
pathway to produce the
cor