Testosterone Implants

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Testosterone

Patient Information leaflet

TESTOSTERONE IMPLANTS

_Testosterone_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Testosterone
Implants. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving
Testosterone Implants 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.
You may wish to read it again.
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
WHAT TESTOSTERONE
IMPLANTS ARE USED FOR
Testosterone Implants are used to
treat confirmed testosterone
deficiency in males.
The active substance of Testosterone
Implants is testosterone. In men,
testosterone is produced by the
testicles. It is necessary for the
normal growth, development and
function of the male sex organs and
for secondary male sex
characteristics. It is also necessary
for the growth of body hair, the
development of bones and muscles,
and it stimulates the production of
red blood cells It also makes men's
voices deepen. Preparations
containing testosterone are used to
replace testosterone in a person who
has low or no natural testosterone (a
condition known as hypogonadism).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
A doctor's prescription is required to
obtain this medicine.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU USE
TESTOSTERONE IMPLANTS
_WHEN YOU MUST NOT BE GIVEN_
_IT_
•
If you have or have had a tumour
of your prostate or breast or are
suspected to have one of these
tumours.
•
If you are allergic to one or more

Summary of Product characteristics

Testosterone Implants V3 

 1  

PRODUCT INFORMATION 

TESTOSTERONE IMPLANTS 

NAME OF THE MEDICINE 

TESTOSTERONE IMPLANTS 100MG OR 200MG 

_Molecular formula:_ C
19
H
28
O
2
    _Molecular mass:_ 288.4   
_CAS No:_ 58-22-0 
_Chemical name:_ 17

-hydroxyandrost-4-en-3-one 

DESCRIPTION 

Testosterone is a white, crystalline powder, odourless or almost
odourless produced semi-synthetically 
from plant origin. It is practically insoluble in water,
freely soluble in ethanol (96%) and slightly soluble 
in ethyl oleate. Its melting point is 152
0
 C to 156
0
 C. 

Testosterone Implants are for
subcutaneous use. Testosterone Implants are white to pale
yellow, 
opaque or translucent and have a common cylindrical shape with a
diameter of 4.5 mm and a length 
of 6 mm (100 mg) or 12 mm (200 mg), individually packed in
sealed glass tubes, with white snap rings 
and secured by two cotton-wool plugs.    

Testosterone implants is made of 100 mg testosterone. 
Testosterone implants is made of 200 mg testosterone.  

PHARMACOTHERAPEUTIC GROUP: Androgens. ATC code G03B A03 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 

Testosterone Implant inserted once every 5-6
months delivers plasma levels of testosterone and 
dihydrotestosterone in
the normal physiological range of healthy males.
In males with primary 
(hypergonadotropic) hypogonadism treatment
with Testosterone Implants results in a normalisation of 
gonadotropin levels.  

In hypogonadal men, treatment
with Testosterone Implants results in an improvement
of testosterone 
deficiency symptoms. Moreover, treatment
increases bone mineral density and lean body mass, and 
decreases body fat mass. Treatment also improves sexual function,
including libido and erectile 
function. Treatment decreases serum LDL-C, HDL-C and triglycerides,
increases haemoglobin and 
h