EXETAS 25MG TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EXEMESTANE

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

EXEMESTANE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LTD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
1
Exetas 25 mg Tablets
Exemestane Tablets (25 mg)
What is in this leaflet
1.
What Exetas 25mg Tablets
is used for.
2.
How Exetas works.
3.
Before you use Exetas
4.
How to take Exetas.
5.
While you are using Exetas
6.
Side effects.
7.
After using Exetas
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision.
What Exetas 25mg Tablets is
used for
Exetas
25mg
Tablets
is
indicated
for
the
adjuvant
treatment
of
postmenopausal
women with oestrogen receptor
positive
invasive
early
breast
cancer, following 2 – 3 years of
initial
adjuvant
tamoxifen
therapy.
Exetas
is
indicated
for
the
treatment
of
advanced
breast
cancer in women with natural or
induced
postmenopausal
status
whose
disease
has
progressed
following
anti-oestrogen
therapy. Efficacy has not been
demonstrated
in
patients
with
oestrogen
receptor
negative
status.
How Exetas works
Exetas belongs to a group of
medicines known as aromatase
inhibitors. These drugs interfere
with
a
substance
called
aromatase,
which
is
needed
to
make the female sex hormones,
estrogens,
especially
in
postmenopausal
women.
Reduction in oestrogen levels in
the
body
is a
way
of
treating
hormone
dependent
breast
cancer.
Before you use Exetas
-When you must not take it

You
are
allergic
to
exemestane
or
any
of
the
other ingredients of Exetas
tablets.

You still have periods, i.e. if
you
have
not
yet
gone
through the menopause.

You are pregnant

You are breast-feeding
-Before you start to take it

Before
treatment
with
Exetas,
your
doctor
may
want to take blood samples
to make sure you have
reached the menopause.

Tell your doctor if you have
problems with your liver or
kidneys

Tell your doctor if you have
a
history
of
osteoporosis
(thinning or wasting of
bones) or bone fractures.
-Taking other medicines

Please tell your doctor or
pharmacist
if
you
are
taking or have recently
taken any other medicines,
including
medicines
obtained
without
a
prescription.
Children and adolescents (b

Ciri produk

EXETAS 25 MG TABLET
Exemestane Tablets 25 mg
COMPOSITION:
EACH FILM COATED TABLET CONTAINS:
Exemestane
25 mg
DOSAGE FORM: Tablet
PRODUCT DESCRIPTION
White to off –white , round, biconvex film coated tablets debossed
with
‘E25’ on one side and plain on the other.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
group:
steroidal
aromatase
inhibitor;
anti-
neoplastic agent
ATC: L02BG06
Exemestane
is
an
irreversible,
steroidal
aromatase
inhibitor,
structurally
related
to
the
natural
substrate
androstenedione.
In
post-menopausal women, oestrogens are produced primarily from the
conversion
of
androgens
into
oestrogens
through
the
aromatase
enzyme
in
peripheral
tissues.
Oestrogen
deprivation
through
aromatase
inhibition
is
an
effective
and
selective
treatment
for
hormone dependent breast cancer in postmenopausal women. In
postmenopausal women, Exemestane p.o. significantly lowered serum
oestrogen concentrations starting from a 5 mg dose, reaching maximal
suppression (>90%) with a dose of 10-25 mg. In postmenopausal
breast cancer patients treated with the 25 mg daily dose, whole body
aromatization 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 multiple daily
doses
trials,
Exemestane
had
no
detectable
effects
on
adrenal
biosynthesis of cortisol or aldosterone, measured before or after ACTH
challenge, thus demonstrating its selectivity with regard to the other
enzymes involved in the steroidogenic pathway. Glucocorticoid or
mineralocorticoid replacement are therefore not needed.
PHARMACOKINETIC PROPERTIES
ABSORPTION:
After
oral
administration
of
Exemestane
tablets,
exemestane
is
absorbed
rapidly.
The
fraction
of
the
dose
absorbed
from
the
gastrointestinal tract is high. The absolute bioavailability in humans
is
unknown, although it is anticipated to be limited by an extensive
first
pass effect. A similar effect resulted in an absolute bioavailability
in rats
and d