Mofecon 500 (Mycophenolate Mofetil 500mg Tablets)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MYCOPHENOLATE MOFETIL

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

MYCOPHENOLATE MOFETIL

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

CONCORD BIOTECH LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MOFECON 500 (MYCOPHENOLATE
MOFETIL 500MG TABLETS)
MYCOPHENOLATE MOFETIL (500MG)
1
WHAT IS IN THIS LEAFLET
1.
What Mofecon is used for
2.
How Mofecon works
3.
Before you use Mofecon
4.
How to use Mofecon
5.
While you are using Mofecon
6.
Side effects
7.
Storage and Disposal of Mofecon
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT MOFECON IS USED FOR
Mofecon
is
indicated
to
prevent
the
body
from
rejecting
a
transplanted
organ
in
patients
receiving
kidney,
heart
or
liver
transplants
in
combination
with
drugs
like
ciclosporin and corticosteroids.
Mofecon
is
used
for
treatment
of
kidney
inflammation,
lupus
nephritis
and it should be used together with
other
medicine
known
as
corticosteroids.
HOW MOFECON WORKS
Mofecon
belongs
to
a
drug
class
“immunosuppressant”.
It
reduces
immune response from your body.
BEFORE YOU USE MOFECON
_ _
_- When you must not use it _
Do not take Mofecon
•
If you are allergic (hypersensitive)
to
mycophenolate
mofetil,
mycophenolic acid or any of the
other ingredients listed at the end
of this leaflet.
•
If you are a woman who could be
pregnant and not using effective
contraception
•
If you are pregnant or planning to
become pregnant or think you may
be pregnant
•
If you are breast-feeding
If you are not sure, talk to your doctor
or pharmacist before taking Mofecon.
_- Before you start to use it _
Tell your doctor straight away before
start using Mofecon:
•
If you are pregnant or planning to
become pregnant
•
If you are breast-feeding or plan to
breast-feed
•
If you are a sexually active man
•
If you are allergic
to any other
medicines,
foods,
dyes
or
preservatives
•
If
you
have
any
other
health
problems, especially the following:
- a history of sun spots or skin
cancers.
- a history of low blood counts of
neutrophils (a type of white blood
cell).
- a history of serious stomach or
bowel problems (such as ulcers or
bleeding).
-kidney disease.
-rare
heredit

Ciri produk

MOFECON
TM 500 (MYCOPHENOLATE MOFETIL 500 MG TABLETS)
VIMOF06-var (MY SIN)
DESCRIPTION
Lavender-colored, caplet-shaped, film-coated tablet, debossed with
“C4”
on one side and plain on the other side.
COMPOSITION
Each tablet contains: Mycophenolate mofetil 500mg
_Excipients:_ Microcrystalline cellulose, croscarmellose sodium,
povidone,
magnesium stearate, hypromellose, titanium dioxide, polyethylene
glycol,
iron oxide red, indigo carmine aluminium lake, black iron oxide.
PHARMACODYNAMICS
Mycophenolate mofetil is an immunosuppressive agent. Mycophenolate
mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent,
selective,
uncompetitive
and
reversible
inhibitor
of
inosine
monophosphate
dehydrogenase, and therefore inhibits the _de novo_ pathway of
guanosine
nucleotide synthesis without incorporation into DNA. Because T- and
B-lymphocytes are critically dependent for their proliferation on _ de
novo_
synthesis
of
purines
whereas
other
cell
types
can
utilise
salvage
pathways, MPA has more potent cytostatic effects on lymphocytes than
on
other cells.
PHARMACOKINETICS
ABSORPTION AND DISTRIBUTION
Following oral administration, mycophenolate mofetil undergoes rapid
and
extensive absorption and complete presystemic metabolism to the active
metabolite, MPA. As evidenced by suppression of acute rejection
following
renal transplantation, the immunosuppressant activity of Mofecon is
correlated with MPA concentration. Food had no effect on the extent of
absorption of mycophenolate mofetil. There is a significant amount of
enterohepatic recirculation for mycophenolate mofetil. MPA at
clinically
relevant concentrations is 97% bound to plasma albumin.
BIOTRANSFORMATION AND ELIMINATION
MPA
is
metabolised
principally
by
glucuronyl
transferase
(isoform
UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG). _ In
_
_vivo_, MPAG is converted back to free MPA via enterohepatic
recirculation.
A
minor
acylglucuronide
(AcMPAG)
is
also
formed.
AcMPAG
is
pharmacologically active and is suspected to be responsible for some