CAPECITABINE MYX capecitabine 150 mg film-coated tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

Capecitabine

থেকে পাওয়া:

Accord Healthcare Pty Ltd

INN (আন্তর্জাতিক নাম):

Capecitabine

তথ্য লিফলেট

V 0.1
1
CAPECITABINE MYX
_capecitabine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Capecitabine MYX.
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 Capecitabine
MYX against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CAPECITABINE
MYX IS USED FOR
Capecitabine MYX contains the
active ingredient capecitabine.
Capecitabine MYX belongs to a
group of medicines called anti-
neoplastic agents. Within this group,
Capecitabine MYX belongs to a class
of medicines called fluoropyrimidine
analogues.
Capecitabine MYX is used to treat
cancer of the bowel and rectum
(colorectal), breast and stomach and
food pipe (oesophagus). It may be
prescribed alone or in combination
with other medicines used to treat
cancer, such as chemotherapy
medicines.
The medicine contained in
Capecitabine MYX, is converted by
the liver and cancer cells to another
medicine called 5-fluorouracil (also
called 5-FU).
It is 5-FU that acts to kill or stop the
growth of cancer cells.
Your doctor may have prescribed
Capecitabine MYX for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY CAPECITABINE MYX
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Capecitabine MYX is not addictive.
BEFORE YOU TAKE
CAPECITABINE MYX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CAPECITABINE MYX IF:
1.
YOU HAVE HAD AN ALLERGY TO
•
CAPECITABINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
•
5-FLUOROURACIL (ALSO CALLED 5-
FU), A MEDICINE USED TO TREAT
CANCER
•
OTHER FLUOROPYRIMIDINE
MEDICINES
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face

পণ্য বৈশিষ্ট্য

Product Information
V2.0
1
CAPECITABINE MYX
(CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG)
NAME OF THE MEDICINE
Capecitabine
(CAS Registry Number: 154361-50-9)
The chemical name for capecitabine is
5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]- cytidine
with the molecular formula C
15
H
22
FN
3
O
6
and a molecular weight of 359.35.
DESCRIPTION
Capecitabine is an oral, antineoplastic agent belonging to the
fluoropyrimidine carbamate
class. It was rationally designed as an orally administered precursor
of 5’-deoxy-5-
fluorouridine (5’-DFUR), which is selectively activated to the
cytotoxic moiety, fluorouracil,
in tumours. Capecitabine is a white to off-white crystalline powder
with an aqueous
solubility of 26 mg/mL at 20°C.
Capecitabine MYX is supplied as oblong shaped, biconvex film-coated
tablets for oral
administration. Each light peach coloured tablet contains 150 mg
capecitabine and each
peach coloured tablet contains 500 mg capecitabine. The inactive
ingredients in Capecitabine
MYX are lactose anhydrous, cellulose microcrystalline, croscarmellose
sodium,
hypromellose, and magnesium stearate. The peach or light peach film
coating contains
hypromellose, purified talc, titanium dioxide and iron oxide yellow
and iron oxide red.
PHARMACOLOGY
Capecitabine itself is non-cytotoxic; however, it is selectively
activated to the cytotoxic
moiety, fluorouracil (5-FU), by thymidine phosphorylase in tumours.
PHARMACODYNAMICS
BIOACTIVATION
Capecitabine is a fluoropyrimidine carbamate derivative that was
designed as an orally
administered, tumour-activated and tumour-selective cytotoxic agent.
Capecitabine is
noncytotoxic
_in vitro_
.
Capecitabine is absorbed unchanged from the gastrointestinal tract,
metabolised primarily
in
the liver by the 60 kDa carboxylesterase to
5’-deoxy-5-fluorocytidine (5’-DFCR), which is
then converted to 5’-DFUR by cytidine deaminase, principally located
in the liver and
tumour tissue. Further metabolism of 5’-DFUR to the
pharmacologically active
agent 5-FU
occurs mainly at the sit