INTACAPE 500MG TABLETS

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

CAPECITABINE

थमां उपलब्ध:

ACCORD HEALTHCARE SDN.BHD.

INN (इंटरनेशनल नाम):

CAPECITABINE

पैकेज में यूनिट:

120tablet Tablets; 120tablet Tablets

द्वारा बनाया गया:

INTAS PHARMACEUTICALS LIMITED

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INTACAPE 500MG TABLETS
_Capecitabine Tablets (500 mg_
_)_
WHAT IS IN THIS LEAFLET?
1.
What INTACAPE is used for
2.
How INTACAPE works
3.
Before you use INTACAPE
4.
How to take INTACAPE
5.
While you are using
INTACAPE
6.
Side effects
7.
Storage and disposal of
INTACAPE
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT INTACAPE IS USED FOR
INTACAPE is a prescription
medicine used to treat people with:
□
breast cancer that has spread
to other parts of the body
(metastatic) together with
another medicine called
docetaxel after treatment with
certain other anticancer
medicines have not worked.
□
breast cancer that has spread
to other parts of the body and
has not improved after
treatment with taxanes and
anthracyclines, or who cannot
receive any more treatment
with certain anti-cancer
medicines.
□
After surgery of stage III
cancer of the colon (Dukes’ C
stage.
□
cancer of the colon or rectum
(colorectal) that has spread to
other parts of the body
(metastatic).
□
As 1
st
line treatment for
patients with cancer of the
foodpipe (esophagus) or
stomach in combination with
drugs belonging to the class
platinums.
It is not known if INTACAPE is
safe and effective in children.
HOW INTACAPE WORKS
INTACAPE belongs to the group
of medicines called "cytostatic
medicines", which stop the growth
of cancer cells. INTACAPE
contains capecitabine, which itself
is not a cytostatic medicine. Only
after being absorbed by the body is
it changed into an active anti-
cancer medicine (more in tumour
tissue than in normal tissue).
BEFORE YOU USE INTACAPE
When you must not take it
Do not take INTACAPE if you:
□
have severe kidney problems.
□
are allergic to capecitabine, 5-
fluorouracil, or any of the
ingredients in INTACAPE.
See the end of this leaflet for a
complete list of ingredients in
INTACAPE.
□
Talk to your doctor before
taking INTACAPE if you are
not sure if you have any of the
conditions listed above.
Before you start to

उत्पाद विशेषताएं

PACKAGE INSERT
INTACAPE 500 mg Tablets (Capecitabine Tablets USP 500 mg)
A)
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each film coated tablet contains:
Capecitabine USP 500 mg
B)
PRODUCT DESCRIPTION
Peach coloured, oblong shaped, biconvex, film coated tablets, debossed
with ‘500’ on one
side and plain on other side.
C)
PHARMACODYNAMICS/ PHARMACOKINETICS
_Pharmacodynamic properties _
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which
functions as an orally
administered
precursor
of
the
cytotoxic
moiety
5-fluorouracil
(5-FU).
Capecitabine
is
activated via several enzymatic steps. The enzyme involved in the
final conversion to 5-FU,
thymidine phosphorylase (ThyPase), is found in tumour tissues, but
also in normal tissues,
albeit usually at lower levels. In human cancer xenograft models
capecitabine demonstrated a
synergistic effect in combination with docetaxel, which may be related
to the upregulation of
thymidine phosphorylase by docetaxel.
There
is
evidence
that
the
metabolism
of
5-FU
in
the
anabolic
pathway
blocks
the
methylation reaction of deoxyuridylic acid to thymidylic acid, thereby
interfering with the
synthesis of deoxyribonucleic acid (DNA). The incorporation of 5-FU
also leads to inhibition
of RNA and protein synthesis. Since DNA and RNA are essential for cell
division and
growth, the effect of 5-FU may be to create a thymidine deficiency
that provokes unbalanced
growth and death of a cell. The effects of DNA and RNA deprivation are
most marked on
those cells which proliferate more rapidly and which metabolise 5-FU
at a more rapid rate.
_Pharmacokinetic properties _
The pharmacokinetics of capecitabine have been evaluated over a dose
range of 502-3514
mg/m2/day. The parameters of capecitabine, 5'-deoxy-5-fluorocytidine
(5'-DFCR) and 5'-
deoxy-5-fluorouridine (5'-DFUR) measured on days 1 and 14 were
similar. The AUC of 5-
FU
was
30%-35%
higher
on
day
14.
Capecitabine
dose
reduction
decreases systemic
exposure to 5-FU more than dose-proportionally, due to non-linear
pharmacokinetics for the