TESTOGEL testosterone 1% gel bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

testosterone, Quantity: 0.0125 g

Available from:

Besins Healthcare Australia Pty Ltd

INN (International Name):

Testosterone

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: ethanol; isopropyl myristate; purified water; carbomer 980; sodium hydroxide

Administration route:

Transdermal

Units in package:

2 x 88 g bottles, 1 x 88 g bottle (60 doses), 1 x 88g bottle (as starter pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Product summary:

Visual Identification: Transparent or slightly opalescent gel; Container Type: Bottle; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-11-07

Patient Information leaflet

TESTOGEL
®
CMI v0920
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
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT USE TESTOGEL IF YOU HAVE
OR ARE SUSPECTED TO HAVE:
•
prostate cancer
•
breast cancer in males
TESTOGEL MUST NOT BE USED BY
CHILDREN UNDER THE AGE OF 18
YEARS.
The safety

Summary of Product characteristics

0720 Testogel PI AUST R 96129 AUST R 96131 AUST R 227563
1
AUSTRALIAN PRODUCT INFORMATION – TESTOGEL™ (TESTOSTERONE)
1.
NAME OF THE MEDICINE
Testosterone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Testogel contains 1% testosterone.
Testogel
also
contains
the
excipients:
isopropyl
myristate,
ethanol, carbomer
980,
sodium hydroxide and purified water.
Excipient with known effect: Ethanol
3.
PHARMACEUTICAL FORM
Testogel
is
a
clear,
colourless,
hydroalcoholic
transdermal
gel
containing
1%
testosterone.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Testogel
is
indicated
for
use
as
testosterone
replacement
therapy
for
male
hypogonadism when testosterone deficiency has been confirmed by
clinical features and
biochemical tests.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULT MEN
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone which
equates to four
pump actuations, two 25 mg sachets* or one 50 mg sachet) applied once
daily at about
the same time, preferably in the morning. The daily dose should be
adjusted by the
doctor depending on the clinical or laboratory response in individual
patients, not
exceeding 10 g of gel per day. The adjustment of dosage should be
achieved by 2.5 g of
gel steps.
Lower doses may be required in renal or hepatic impairment.
Steady state plasma testosterone concentrations are reached by the end
of the 2
nd
day
of treatment with Testogel. In order to adjust the testosterone dose,
serum testosterone
concentrations must be measured in the morning before application from
the 3
rd
day on
after starting treatment (one week seems reasonable). The dose may be
reduced if the
plasma
testosterone
concentrations
are
raised
above
the
desired
level.
If
the
0720 Testogel PI AUST R 96129 AUST R 96131 AUST R 227563
2
concentrations are low, the dosage may be increased, not exceeding 10
g of gel per
day.
METHOD OF ADMINISTRATION
Transdermal use.
The application should be administered by the patient himself, onto
clean, dry, healthy
skin over either shoulder or either arm or abdomen.
If u