NTP-BICALUTAMIDE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BICALUTAMIDE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

L02BB03

INN (nume internaţional):

BICALUTAMIDE

Dozare:

50MG

Forma farmaceutică:

TABLET

Compoziție:

BICALUTAMIDE 50MG

Calea de administrare:

ORAL

Unități în pachet:

30/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0127996001; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2015-08-06

Caracteristicilor produsului

PRODUCT MONOGRAPH
Pr
NTP-BICALUTAMIDE
(bicalutamide)
50 mg Tablets
Non-Steroidal Antiandrogen
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165861
Date of Preparation:
July 12, 2013
2
PRODUCT MONOGRAPH
Pr
NTP-BICALUTAMIDE
(bicalutamide)
50mg Tablets
Non-Steroidal Antiandrogen
CLINICAL PHARMACOLOGY
NTP-BICALUTAMIDE (bicalutamide) is a non-steroidal antiandrogen,
devoid of other
endocrine activity. Bicalutamide competitively inhibits the action of
androgens by binding to
cytosol androgen receptors in target tissue. This inhibition results
in regression of prostatic
tumours. NTP-BICALUTAMIDE is a racemate and the (R)-enantiomer is
primarily
responsible for the antiandrogenic activity of NTP-BICALUTAMIDE.
PHARMACOKINETICS AND METABOLISM
The
absorption,
distribution,
metabolism
and
excretion
of
bicalutamide
has
been
investigated after administration of a single 50 mg oral dose to
volunteers. The results
indicated that the dose was extensively absorbed and was excreted
almost equally in urine
(36%) and faeces (43%) over a 9 day collection period. There is no
evidence of any
clinically significant effect of food on bioavailability. Steady state
plasma concentrations of
3
the (R)-enantiomer of approximately 9
F
g/ml are observed during daily administration of 50
mg doses of bicalutamide. At steady state, the active (R)-enantiomer
accounts for 99% of
the circulating plasma bicalutamide concentration. Bicalutamide is
highly protein bound
(racemate 96%, R-enantiomer 99.6%). On daily administration, the
(R)-enantiomer
accumulates
about
10-fold
in
plasma,
consistent
with
an
elimination
half-life
of
approximately one week. The (S)-enantiomer is very rapidly cleared
relative to the
(R)-enantiomer. The pharmacokinetics of the (R)-enantiomer are
unaffected by age, renal
impairment or mild to moderate hepatic impairment. Patients with
severe hepatic
impairment eliminate the (R)-enantiomer from plasma more slowly.
Bicalutamide is
extensively metabolized via both oxidation and glucuronid