Cyprone

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CYPRONE
1
CYPRONE
_Cyproterone acetate_
CONSUMER PRODUCT INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine.
It does not contain all of the
available information.  It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Cyprone against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CYPRONE IS USED
FOR
Cyprone is used for a number of
conditions, as follows:-
*
in the treatment of women who
have a problem with facial or
chest hair, are balding, or have
severe acne
*
in the treatment of men with
cancer of the prostate gland
*
to reduce the sex drive of men
with sexual deviations
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CYPRONE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Cyprone for another purpose.
Cyprone is a hormone preparation
that works by reducing the effects
and the levels of male sex hormones
in the body.  [These male sex
hormones are also produced by
women in small amounts, and if the
body produces too much or is overly
sensitive, then masculine features can
occur in women].
Cyprone is available only with a
doctor's prescription.
There is no evidence that Cyprone is
addictive.
BEFORE YOU TAKE
CYPRONE
Female patients should be aware that
the long-term effects of Cyprone on
fertility are not known.
Male patients should be aware that
Cyprone causes a decrease in sperm
count. It may take 3 to 20 months for
the sperm count to return to normal
once therapy has been stopped.
Patients should be aware that there
have been reports of liver damage
including liver failure, tumours and
bleeding into the liver in patients
receiving high doses of cyproterone
acetate.  Consu

Summary of Product characteristics

CYPRONE  
YPRONE  
_Cyproterone Acetate _
_Cyproterone Acetate _
PRODUCT INFORMATION 
PRODUCT INFORMATION 

NAME OF THE MEDICINE 

The active ingredient of Cyprone tablets is cyproterone acetate. 

The chemical name for cyproterone acetate is 6-chloro-17-hydroxy-1
α,2α-methylenepregna-4,6-diene-3,20- 
dione acetate.  Its structural formula is:  
O
Cl
Me
H
Me
OAc
H
2
C
H
H
O
CH
3

Molecular formula: C
24
H
29
ClO
4

  Molecular 
weight: 
416.94 

CAS Registry No.: 
427-51-0 

DESCRIPTION

Cyproterone acetate is a white to pale yellow, odourless crystalline
powder. It is practically insoluble in water. 

Each Cyprone tablet contains 50 mg of cyproterone acetate.  

The tablets also contain the following inactive excipients: lactose,
maize starch, povidone, colloidal anhydrous 
silica and magnesium stearate.  _The tablets are gluten free._ 

PHARMACOLOGY

Cyproterone acetate is a synthetic antiandrogenic
hormone preparation. It is believed to prevent the effect of 
endogenously produced and exogenously administered androgens at the
target organs by means of competitive 
inhibition.  The stimulating effect of male sex hormones on androgen
dependent structures and functions is 
weakened or counteracted by cyproterone acetate. 

Cyproterone acetate also exerts a progestational and antigonadotrophic
effect. 

Treatment with cyproterone acetate in men results in a reduction
of sexual drive and potency and inhibition of 
gonadal function.  These changes are reversible
following discontinuation of therapy. The function of androgen 
dependent target organs, such as the prostate, is restricted. 

Prostatic carcinoma and its metastases are in general androgen
dependent. Cyproterone acetate exerts a direct 
antiandrogenic action on the tumour and its metastases, and in
addition it exerts a negative feedback effect on the 
hypothalamic receptors, thereby leading to a reduction in
gonadotrophin release, and hence to di