EUFLEX TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

FLUTAMIDE

Tilgængelig fra:

MERCK CANADA INC

ATC-kode:

L02BB01

INN (International Name):

FLUTAMIDE

Dosering:

250MG

Lægemiddelform:

TABLET

Sammensætning:

FLUTAMIDE 250MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0116869001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2015-06-01

Produktets egenskaber

PRODUCT MONOGRAPH
EUFLEX
®
(flutamide 250 mg tablets)
Non-Steroidal Antiandrogen
Merck Canada Inc.
Date of preparation:
16750 route Transcanadienne
January 31, 2011
Kirkland, Quebec H9H 4M7
www.merck.ca
DATE OF REVISION:
OCTOBER 15, 2012
CONTROL #: 157238
®
Registered trademark of Schering-Plough Canada Inc. Used under
license.
EUFLEX
®
(flutamide)
2
PRODUCT MONOGRAPH
EUFLEX
®
(flutamide 250 mg tablets)
THERAPEUTIC CLASSIFICATION
NON-STEROIDAL ANTIANDROGEN
ACTION AND CLINICAL PHARMACOLOGY
Flutamide demonstrates potent antiandrogenic effects by inhibiting
androgen uptake and/or
inhibiting nuclear binding of androgen in target tissues. In adult
male rats, ventral prostate
weights and seminal vesicle weights were markedly reduced by daily
administration of
flutamide.
PHARMACOKINETICS
Analysis of plasma, urine, and feces following a single oral 200 mg
dose of tritium-labelled
flutamide to human volunteers showed that the drug is rapidly and
completely absorbed. It is
excreted mainly in the urine with 4.2% of the dose excreted in the
faeces over 72 hours. The
composition
of
plasma
radioactivity
showed
that
flutamide
is
rapidly
and
extensively
metabolized,
with
flutamide
comprising
2.5%
of
plasma
radioactivity
one
hour
after
administration. At least six metabolites have been identified in
plasma. The major plasma
metabolite is a biologically active alpha-hydroxylated derivative,
which accounts for 23% of
the plasma tritium one hour after drug administration. The major
urinary metabolite is 2-
amino-5-nitro-4-(trifluoromethyl)phenol.
Following a single 250 mg oral dose to normal adult volunteers, low
plasma levels of varying
amounts of flutamide were detected. The biologically active
alpha-hydroxylated metabolite
reaches maximum plasma levels in about two hours, indicating that it
is rapidly formed from
flutamide. The plasma half-life for this metabolite is about 6 hours.
Following multiple oral dosing of 250 mg three times a day in normal
geriatric volunteers,
flutamide
and
its
active
metabolite
approached
steady-s