ANDRODERM testosterone 24.3 mg per patch transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

testosterone, Quantity: 24.3 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: ethanol; sodium hydroxide; glyceryl monooleate; methyl laurate; carbomer copolymer (type B); glycerol; purified water; ethyl acetate; toluene; acrylates/VA copolymer

Administration route:

Transdermal

Units in package:

5 patches, 30 patches

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for testosterone replacement therapy for confirmed testosterone deficiency in males.

Product summary:

Visual Identification: A SKIN COLOURED PATCH, ELLIPTICAL WITH DISTINCT HEAT SEAL RINGS. PACKAGE IN A HEAT SEALED POUCH.; Container Type: Sachet; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-04-10

Patient Information leaflet

ANDRODERM
®
_Testosterone (tes-TOS-te-rone)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
Androderm
®
. 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 possible risks of you using
Androderm
®
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANDRODERM
® IS
USED FOR
Androderm
®
is used to replace
testosterone in males when the body
is unable to produce enough of its
own. Testosterone is a hormone that
is necessary for the normal
development and maintenance of
male reproductive tissues and other
characteristic male traits.
Androderm
®
is a testosterone
transdermal delivery patch. This
means that when the patch is applied
to the skin, the testosterone passes
from the patch, through the skin and
into the bloodstream.
The testosterone in Androderm
®
is
identical to the naturally occurring
testosterone present in the body.
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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
There is not enough information to
recommend the use of this medicine
for children below the age of 15
years.
BEFORE YOU USE
ANDRODERM
®
_WHEN YOU MUST NOT USE IT_
DO NOT USE ANDRODERM
® IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
testosterone
•
any of the ingredients listed at the
end of this leaflet.
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

Summary of Product characteristics

Version 11
1
AUSTRALIAN PRODUCT INFORMATION – ANDRODERM
®
(TESTOSTERONE) TRANSDERMAL PATCH
1
NAME OF THE MEDICINE
Testosterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The structure of testosterone (17

-hydroxyandrost-4-en-3-one) is given below. The molecular
weight of the compound is 288.4. Testosterone is a white crystalline
powder, or colourless or
yellowish-white crystals, practically insoluble in water, freely
soluble in alcohol and in methylene
chloride, practically insoluble in fatty oils.
Androderm® provides continuous delivery of testosterone for 24 hours
following application to
intact, non-scrotal skin (e.g. back, abdomen, thighs, upper arms).
Two strengths of Androderm® Transdermal Patch are available which
deliver _in vivo_ 2.5 mg or 5 mg
of testosterone per day across skin of average permeability.
The Androderm® 2.5 mg/day Transdermal Patch has a 7.5 cm
2
active surface area and contains 12.2
mg testosterone USP. The Androderm® 5 mg/day Transdermal Patch has a
15 cm
2
active surface
area and contains 24.3 mg testosterone USP.
Excipients with known effect: ethanol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Androderm® is a transdermal drug delivery system consisting of a self
adhesive patch surrounding a
central drug reservoir of testosterone dissolved in an alcohol-based
gel.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Androderm® is indicated for testosterone replacement therapy for
confirmed testosterone
deficiency in males.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual dose is one Androderm® 5 mg/day Transdermal Patch applied
nightly (approximately
10.00pm) and worn for 24 hours, providing approximately 5 mg
testosterone per day.
The dose can be adjusted up to 7.5 mg/day (i.e., one 5 mg/day and one
2.5 mg/day patches or three
2.5 mg/day patches) nightly or down to 2.5 mg/day (i.e., one 2.5
mg/day patch) nightly depending
on the serum testosterone measured in the morning after the
application. Measurement of serum
Version 11