PMS-FLUTAMIDE TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ixtrih issa

Ingredjent attiv:

FLUTAMIDE

Disponibbli minn:

PHARMASCIENCE INC

Kodiċi ATC:

L02BB01

INN (Isem Internazzjonali):

FLUTAMIDE

Dożaġġ:

250MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

FLUTAMIDE 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

1996-11-25

Karatteristiċi tal-prodott

                                _ _
_pms-FLUTAMIDE Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
PMS-FLUTAMIDE
Flutamide Tablets
250 mg
Non-steroidal antiandrogen
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
SUBMISSION CONTROL NO
: 158262
Date of Revision:
December 18, 2012
_ _
_pms-FLUTAMIDE Product Monograph _
_Page 2 of 31_
PRODUCT MONOGRAPH
NAME OF DRUG
pr
pms-FLUTAMIDE
Flutamide Tablets
250 mg
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 only 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.
_ _
_pms-FLUTAMIDE Product Monograph _
_Page 3 of 31_
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 voluntee
                                
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