TESTOGEL testosterone 1% 2.5g sachets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

testosterone, Quantity: 0.025 g

Available from:

Besins Healthcare Australia Pty Ltd

Pharmaceutical form:

Gel

Composition:

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

Administration route:

Transdermal

Units in package:

1, 2, 7, 10, 14, 28, 30, 50, 60, 90, 100 x2.5g sachets

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: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-01-07

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