Trozet Tablets 2.5mg

Country: Малезија

Језик: Енглески

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

Активни састојак:

LETROZOLE

Доступно од:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Међународно име):

LETROZOLE

Јединице у пакету:

28 mcg/mL; 30 Tablet Tablets; 28 Tablet Tablets

Произведен од:

Fresenius Kabi Oncology Limited

Информативни летак

Consumer Medication Information Leaflet (RiMUP)
1
TROZET
Letrozole Tablets USP 2.5 mg
WHAT IS IN THIS LEAFLET
1. What TROZET is and what
it is used for
2. How does TROZET works
3. What you need to know
before you take TROZET
4. How to take TROZET
5. While you are using
TROZET
6. Possible side effects
7. How to store and dispose
TROZET
8. Product Description
1.
WHAT
TROZET
IS
AND
WHAT IT IS USED FOR?
TROZET
contains
an
active
substance
called
letrozole.
It
belongs to a group of medicines
called aromatase inhibitors. It is
a
hormonal
(or
“endocrine”)
breast
cancer
treatment.
TROZET is used to treat breast
cancer in women who are post-
menopausal
–
thatis,
women
who no longer have periods,
either naturally due to their age
or
after
surgery
or
chemotherapy. It is also used
before
surgery
in
postmenopausal breast cancer
women.
2. HOW TROZET WORKS?
Growth of breast cancer is often
stimulated by estrogens, which
are
female
sex
hormones.
Femara reduces the amount of
estrogen
by
blocking
an
enzyme
(“aromatase”)
involved in the production of
estrogens
and
therefore,
may
block
the
growth
of
breast
cancers that need estrogen to
grow. As a consequence, tumor
cells
slow
or
stop
the
progression and/or spreading to
other parts of the body.
3. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE TROZET?
Follow
all
the
doctor’s
instructions
carefully.
They
may
differ
from
the
general
information
contained
in
this
leaflet.
_- When you must not use it _
•
If
you
are
allergic
(hypersensitive) to letrozole or
to
any
of
the
ingredients
in
Trozet listed in this leaflet. If
you think you may be allergic,
ask your doctor for advice.
• If you still have periods, i.e. if
you have not yet gone through
the menopause.
• If you are pregnant.
• If you are breast-feeding If
any of these conditions apply to
you,
tell
your
doctor
before
taking Trozet.
_PREGNANCY_
You must not take Trozet if you
are pregnant as it may harm
your unborn baby. Your doctor
will
discuss
with
you
the
potential risks of taking Trozet
during
pregnancy.
There
are
report

Карактеристике производа

Page 1 of 7
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
LETROZOLE TABLETS USP 2.5 MG
TROZET
DESCRIPTION:
Letrozole tablets USP for oral administration contains 2.5 mg of
letrozole USP, a nonsteroidal
aromatase inhibitor (inhibitor of estrogen synthesis).
Letrozole is a white to yellowish crystalline powder, freely soluble
in dichloromethane, slightly
soluble in alcohol, sparingly soluble in methanol, and practically
insoluble in water.
Letrozole tablets USP is available as 2.5 mg tablets for oral
administration. It is yellow,
circular, biconvex film coated tablets, debossing with “DB03” on
one side and plain on other
side.
COMPOSITION:
Each Film Coated Tablet contains
Letrozole USP 2.5 mg
_Colour_
: Yellow Iron Oxide and Titanium Dioxide
CHEMICAL STRUCTURE:
It is chemically described as 4,4'-(1H-1, 2,4- Triazol-1-ylmethylene)
dibenzonitrile, and its
structural formula is:
It has a molecular weight of 285.31, empirical formula C17H11N5, and a
melting range of
184°C-185°C.
PHARMACOLOGY:
PHARMACODYNAMICS
The growth of some cancers of the breast is stimulated or maintained
by estrogens. In
postmenopausal women, oestrogens are mainly derived from the action of
the aromatase
enzyme, which convert the adrenal androgens – primarily
androstenedione and testosterone -
to oestrone (E1) and oestradiol (E2). The suppression of oestrogen
biosynthesis in peripheral
tissue and the cancer tissue itself can therefore be achieved by
specifically inhibiting the
aromatase enzyme. Letrozole is a non-steroidal aromatase inhibitor. It
inhibits the aromatase
enzyme by competitively binding to the haem of the cytochrome P450
subunit of enzyme
Page 2 of 7
resulting in a reduction of oestrogen biosynthesis in all tissues. In
healthy postmenopausal
women, single doses of 0.1mg, 0.5mg and 2.5 mg letrozole suppress
serum oestrone and
oestradiol by 75 to 78% and 78% from baseline, respectively. Maximum
suppression is
achieved in 48 to 78 hours. In postmenopausal patient, with advanced
breast cance