Bicalutamide-GA

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Bicalutamide

Beszerezhető a:

Actavis Pty Ltd

Osztály:

Medicine Registered

Betegtájékoztató

Bicalutamide-GA CMI v6 090907 
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BICALUTAMIDE-GA 
_Bicalutamide _
_ _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some of the 
common questions people ask 
about BICALUTAMIDE-GA. It 
does not contain all the 
information that is known about 
BICALUTAMIDE-GA.  

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-GA 
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-GA IS 
USED FOR 

BICALUTAMIDE-GA 50mg is 
used to treat locally advanced 
prostate cancer. 

BICALUTAMIDE-GA is an anti-
androgen medicine. Androgens 
such as testosterone are natural 
male sex hormones. In some 
types of prostate cancer, 
androgens can help the cancer 
cells to grow. Bicalutamide 
interferes with some of the 
actions of these hormones. 

BICALUTAMIDE-GA MUST ONLY 
BE TAKEN BY MEN.  

YOU MUST FOLLOW ALL THE 
DIRECTIONS GIVEN TO YOU BY YOUR 
DOCTOR. They can differ from the 
information in this leaflet. 

Your doctor can prescribe this 
medicine for another use. 
ALWAYS ASK YOUR DOCTOR IF YOU 
NEED MORE INFORMATION. 

BICALUTAMIDE-GA is not 
known to be addictive. 

BICALUTAMIDE-GA is only 
available with a doctor’s 
prescription. 

BEFORE YOU TAKE 
BICALUTAMIDE-GA 
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE BICALUTAMIDE-
GA IF YOU ARE A WOMAN. WOMEN 
DO NOT GET TREATED WITH 
BICALUTAMIDE-GA. 

DO NOT GIVE BICALUTAMIDE-
GA TO CHILDREN. THERE IS NO 
EXPERIENCE OF TREATING CHILDREN 
WITH BICALUTAMIDE-GA. 

DO NOT TAKE BICALUTAMIDE-
GA IF YOU ARE ALLERGIC TO 
BICALUTAMIDE OR ANY OF THE 
OTHER INGREDIENTS IN 
BICALUTAM

Termékjellemzők

BICALUTAMIDE-GA PI v6 110302 
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BICALUTAMIDE-GA 
_PRODUCT INFORMATION _

NAME OF THE MEDICINE  

Bicalutamide 

Bicalutamide is (RS)-4'-cyano-alpha',alpha',alpha',- trifluoro-3-
(4-fluorophenylsulfonyl)-2- hydroxy-2- 
methylpropiono-m- toluidide. Molecular formula is C18H14F4N2O4S. The
molecular weight is 430.38 
g/mol. CAS: 90357-06-5. The molecular weight is 430.38 g/mol.
Structurally it is represented as: 

DESCRIPTION 

Bicalutamide is a fine white to off white powder. At 37 deg. C it is
practically insoluble in water (4.6 
mg/L), acid (4.6 mg/L at pH 1) and alkali (3.7 mg/L at pH 8). In
organic solvents it is slightly soluble in 
ethanol, sparingly soluble in methanol and freely soluble in acetone
and tetrahydrofuran. 

Bicalutamide-GA tablets also contain: lactose, sodium starch
glycollate, povidone, magnesium 
stearate, hypromellose, macrogol 400, titanium dioxide. 

PHARMACOLOGY 

Bicalutamide is a nonsteroidal antiandrogen 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 drug may result in an
antiandrogen 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 is a racemate with its antiandrogenic activity being
almost exclusively in the R-
enantiomer. 

PHARMACOKINETICS 

_Absorption _

BICALUTAMIDE-GA PI v6 110302 
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Bicalutamide is well absorbed following oral administration. There
is no evidence of any clinically 
relevant effect of food on bioavailability. 
_ _
_Distribution _
Bicalutami