BICALUTAMIDE AN bicalutamide 50mg film-coated tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Bicalutamide

Dostupné s:

Juno Pharmaceuticals Pty Ltd

INN (Mezinárodní Name):

Bicalutamide

Informace pro uživatele

_Bicalutamide AN tablets – Consumer Medicine Information _
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_Bicalutamide AN CMI v2.0 _
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_Page 1 _
BICALUTAMIDE AN TABLETS
_Bicalutamide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about
BICALUTAMIDE
AN.
It
does
not
contain
all
the
information that is known about
BICALUTAMIDE AN.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor will have
weighed the risks of you taking
BICALUTAMIDE AN against the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT BICALUTAMIDE
AN IS USED FOR
BICALUTAMIDE AN is used in
combination
with
other
medicines
to
treat
advanced
prostate cancer.
BICALUTAMIDE
AN
is
an
antiandrogen
medicine.
Androgens such as testosterone
are natural male sex hormones.
In
some
types
of
prostate
cancer, androgens may help the
cancer cells to grow.
BICALUTAMIDE
AN
interferes
with some of the actions of these
hormones.
BICALUTAMIDE AN should only
be taken by men.
FOLLOW ALL DIRECTIONS GIVEN TO
YOU BY YOUR DOCTOR.
They
may
differ
from
the
information in this leaflet. Your
doctor
may
prescribe
this
medicine for another use. Ask
your
doctor
if
you
want
more
information.
BICALUTAMIDE
AN
is
not
addictive.
BEFORE YOU TAKE
BICALUTAMIDE AN
_WHEN YOU MUST NOT USE IT _
DO
NOT
TAKE
BICALUTAMIDE
AN IF YOU ARE A WOMAN.
Women are not normally treated
with BICALUTAMIDE AN.
DO
NOT
GIVE
BICALUTAMIDE
AN TO CHILDREN.
There is no experience of its use
in children.
DO
NOT
TAKE
BICALUTAMIDE
AN
IF
YOU
ARE
ALLERGIC
TO
BICALUTAMIDE
OR
ANY
OF
THE
OTHER
INGREDIENTS
IN
BICALUTAMIDE AN.
DO
NOT
TAKE
BICALUTAMIDE
AN IF YOU ARE TAKING CISAPRIDE
OR
THE
ANTIHISTAMINES,
TERFENADINE AND ASTEMIZOLE.
DO
NOT
TAKE
BICALUTAMIDE
AN AFTER THE USE BY (EXPIRY)
DATE PRINTED ON THE PACK.
It may have no effect at all or an
unexpected effect if you take it
after

Charakteristika produktu

_Bicalutamide AN tablets Product Information _
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_Amneal Pharma Australia Pty Ltd _
Bicalutamide AN PI v 2.0
Page 1
BICALUTAMIDE AN
_(BICALUTAMIDE 50MG TABLETS) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Bicalutamide.
CHEMICAL
NAME:
(_RS_)-4'-Cyano-α’,
α’,
α’,-trifluoro-3-(4-fluorophenylsulfonyl)-2-hydroxy-2-
methylpropiono-_m_-toluidide
MOLECULAR FORMULA: C
18
H
14
F
4
N
2
O
4
S
MOLECULAR WEIGHT: 430.38 g/mol
CAS REGISTRY NUMBER: 90357-06-5
DESCRIPTION
Bicalutamide is a fine white to off-white powder. At 37
o
C it is practically insoluble in
water
(4.6 mg/litre), acid (4.6 mg/litre at pH 1) and alkali (3.7 mg/litre
at pH 8). In organic
solvents it is slightly soluble in ethanol, sparingly soluble in
methanol and freely
soluble in
acetone and tetrahydrofuran.
Bicalutamide AN tablets are white film-coated tablets containing 50 mg
bicalutamide. Each
tablet contains the following excipients: lactose, sodium starch
glycollate type A, povidone,
magnesium stearate, hypromellose, macrogol 400 and titanium dioxide.
PHARMACOLOGY
Bicalutamide is a non-steroidal anti-androgen, devoid of other
endocrine activity. It binds
to
androgen receptors without activating gene expression, and thus
inhibits the androgen
stimulus.
This inhibition impairs the growth and encourages apoptosis in
androgen-
dependent tumour
cells and regression of prostatic tumours. In a subset of patients who
experience disease
progression while receiving bicalutamide, discontinuation of the
medicine may result in an
‘anti-androgen withdrawal syndrome’, which manifests as a
fall in prostate specific antigen
(PSA) level. It is unknown whether this phenomenon
translates to a prolongation of tumour
response or survival.
_Bicalutamide AN tablets Product Information _
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_Amneal Pharma Australia Pty Ltd _
Bicalutamide AN PI v 2.0
Page 2
Bicalutamide is a racemate with its antiandrogenic activity being
almost exclusively in
the (R)-
enantiomer.
PHARMACOKINETICS
_Absorption_
Bicalutamide is well absorbed following oral