TESTOGEL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Testosterone

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

TESTOGEL
® 
CMI  

1 
TESTOGEL
® 
(TES·TOE·GEL) 
_testosterone_ 

_CONSUMER MEDICINE INFORMATION _

WHAT IS IN THIS 
LEAFLET 
This leaflet answers some common 
questions about Testogel. 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 using Testogel 
against the benefits they expect it 
will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
USING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE 
MEDICINE.  
You may need to read it again.

WHAT TESTOGEL IS 
USED FOR 
Testogel is used to replace the 
body’s natural hormone 
testosterone when not enough is 
made by the body. 

Testosterone is a natural hormone, 
known as an androgen, which 
controls normal sexual development 
and function in men. 

Testosterone is essential for the 
development and maintenance of 
the male reproductive organs as 
well as other male characteristics, 
such as facial and body hair growth, 
deep voice, sexual drive, muscle 
mass and body fat distribution. 

Testogel is a testosterone-
containing gel that is applied by 
the patient daily to the skin. The 
testosterone passes from the gel 
through the skin and into the 
bloodstream at a steady rate. 

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY THIS 
MEDICINE HAS BEEN PRESCRIBED 
FOR YOU. 
Your doctor may have prescribed 
it for another reason.

BEFORE YOU USE 
TESTOGEL 
_WHEN YOU MUST NOT USE IT _
DO NOT USE TESTOGEL IF YOU HAVE 
AN ALLERGY TO: 
•  testosterone, the active 
ingredient in Testogel 
•  any of the ingredients listed at 
the end of this leaflet. 

Some of the symptoms of an 
allergic reaction may include: 
•  shortness of breath 
•  w

Summary of Product characteristics

110128 Testogel PI 
1
PRODUCT INFORMATION 

TESTOGEL
TM

(TESTOSTERONE) 

NAME OF THE MEDICINE 

Testosterone is an androgen. Chemically testosterone is 17
β-hydroxyandrost-4-en-3-
one and has the following structural formula: 

O
CH
3
CH
3
H
H
H
OH

Chemical Formula: C
19
 H
28
 O
2

Molecular Weight: 288.4 
CAS No: 58-22-0 

DESCRIPTION 

Testosterone is a white, crystalline powder, odourless or almost
odourless produced 
semisynthetically from plant origin. It is practically insoluble in
water, freely soluble in 
ethanol (96%); slightly soluble in ethyl oleate. 

Testogel is a clear, colourless, hydroalcoholic gel containing 1%
testosterone (25 mg in 
2.5 g or 50 mg in 5 g) and the excipients: isopropyl myristate,
ethanol, carbomer 980, 
sodium hydroxide and purified water. 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 

Testogel is an androgen replacement therapy containing the male
hormone 
testosterone.  

Endogenous androgens, principally testosterone, secreted by the
testes and its major 
metabolite dihydrotestosterone (DHT), are responsible for the
development of the 
external and internal genital organs and for maintaining the secondary
sexual 
characteristics (stimulating hair growth, deepening of the voice,
development of the 
libido); for a general effect on protein anabolism; for development of
skeletal muscle and 
body fat distribution; for a reduction in
urinary nitrogen, sodium, potassium, chloride, 
phosphate and water excretion. 
110128 Testogel PI 
2

Testosterone does not produce testicular development: it reduces
the pituitary secretion 
of gonadotropins. 

The effects of testosterone in some target organs arise after
peripheral conversion of 
testosterone to oestradiol, which binds to oestrogen receptors in the
target cell nucleus 
e.g. the pituitary, fat, brain, bone and testicular Leydig cells. 

PHARMACOKINETICS  

Approximately 10% of the testosterone dose applied on the skin
sur