EXEMESTANE AN exemestane 25mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

exemestane

Доступно од:

Southern Cross Pharma Pty Ltd

INN (Међународно име):

Exemestane

Статус ауторизације:

Registered

Информативни летак

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C: Products/ExemestaneAN/CMI 14Feb14
Page
1 of 3
EXEMESTANE AN
_Exemestane _
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START EXEMESTANE AN.
What is in this leaflet
This leaflet answers some common
questions about Exemestane AN.
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 taking Exemestane
AN against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
What Exemestane AN is
used for
Exemestane AN is used to treat
breast cancer in women who no
longer have their menstrual
periods, either naturally due to
their age (after menopause) or
because they have had their
ovaries surgically removed.
Exemestane AN is used to reduce
the risk of recurrence or spreading
of the breast cancer. It is also used
when the cancer has not
responded or has returned after
treatment with another medicine
or medicines.
_ _
_How Exemestane AN works _
Exemestane AN is an aromatase
inactivator. It works by
significantly reducing the supply of
oestrogen to cancer cells.
This stops the growth of those
cancer cells which need oestrogen,
a natural female sex hormone, to
grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EXEMESTANE
AN HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Exemestane AN is only available
with a doctor's prescription. It is
not addictive.
Before you take it
_When you must not take it _
DO NOT TAKE EXEMESTANE AN AND
TALK TO YOUR DOCTOR IF YOU THINK
YOU MAY HAVE AN ALLERGY TO:

exemestane, the active
ingredient in Exemestane AN

any of the other ingredients in
Exemestane AN listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty

Карактеристике производа

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Page 1 of 12
PRODUCT INFORMATION
EXEMESTANE AN
NAME OF THE MEDICINE
PROPRIETARY NAME:
Exemestane AN tablets
NON PROPRIETARY NAME:
Exemestane tablets
CHEMICAL NAME
: 6-methylenandrosta-1,4-diene-3,17-dione.
The chemical structure of exemestane is:
Molecular formula: C
20
H
24
O
2
MW: 296.4
CAS number: 107868-30-4
DESCRIPTION
Exemestane is a white or yellowish white powder, which is freely
soluble in N,N-
dimethylformamide, soluble in methanol and practically insoluble in
water. Due to the
very low solubility in water, the drug is micronised.
EXCIPIENTS
Microcrystalline
cellulose,
crospovidone,
polysorbate
80,
mannitol,
anhydrous
colloidal silica, magnesium stearate, sucrose, acacia, purified talc,
titanium dioxide,
shellac, beeswax white, and carnauba wax yellow.
PHARMACOLOGY
PHARMACODYNAMICS.
Exemestane is an irreversible, steroidal aromatase inactivator,
structurally related to
the natural substrate androstenedione. In postmenopausal women,
oestrogens are
produced primarily from the conversion of androgens into oestrogens
through the
aromatase enzyme in peripheral tissues. Oestrogen deprivation through
aromatase
C:Products/ExemestaneAN/PI _14022014_1
Page 2 of 12
inhibition is an effective and selective treatment for hormone
dependent breast cancer
in postmenopausal women. Exemestane acts by binding irreversibly to
the active site
of the enzyme causing its inactivation. Such a type of inactivation is
also known as
“suicidal inhibition”.
In
postmenopausal
women,
exemestane
significantly
lowered
serum
oestrogen
concentrations starting from a 5 mg dose, reaching maximal suppression
(80 to 90%)
with a dose of 10 to 25 mg. In postmenopausal breast cancer patients
treated with the
25 mg daily dose, whole body aromatisation was reduced by 98%.
Exemestane does not possess any progestogenic or oestrogenic activity.
A slight
androgenic activity, probably due to the 17-hydro derivative, has been
observed
mainly,
at
high
doses.
In
trials
with
multiple
daily
doses,
exemestane
had
no