MYCOKEM CAPSULES 250MG (MYCOPHENOLATE MOFETIL CAPSULES USP)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MYCOPHENOLATE MOFETIL

Boleh didapati daripada:

Ascend Laboratories Sdn Bhd

INN (Nama Antarabangsa):

MYCOPHENOLATE MOFETIL

Unit dalam pakej:

10capsule Capsules; 100capsule Capsules

Dikeluarkan oleh:

Alkem Laboratories Limited

Risalah maklumat

MYCOKEM CAPSULE 250 MG (MYCOPHENOLATE
MOFETIL CAPSULES USP)
Mycophenolate Mofetil (250
mg)
_Con_
_sumer_
_ Medicine Information Leaflet (RiMUP)_
Page 1
WHAT IS IN THIS LEAFLET
1. What Mycokem is used for
2. How Mycokem works
3. Before you use Mycokem
4. How to use Mycokem
5. While you are using it
6. Side effects
5. Storage and disposal of Mycokem
6. Product description
7. Manufacturer
and
Product
Registration Holder
8. Date of revision
WHAT
MYCOKEM
IS USED FOR
MYCOKEM CAPSULE are used to
prevent
your
body
rejecting
a
transplanted kidney, heart or liver.
MYCOKEM CAPSULE is
used
together with other medicines known
as ciclosporin and corticosteroids.
HOW MYCOKEM WORKS
These hard gelatin capsules contain
250mg
of
the
active
ingredient
Mycophenolate Mofetil. This belongs
to
a
group
of
medicines
called
“immunesuppressants”.
These
medication
works
by
lowering
your
body's immune system activity.
BEFORE YOU USE MYCOKEM
_When you must not use it_:
-MYCOKEM CAPSULE should not
be given to women of child bearing
potential
who
are
not
using
highly
effective contraception
-MYCOKEM
CAPSULE
treatment
should not be initiated in women of
child
bearing
potential
without
providing a pregnancy test result to
rule out unintended use in pregnancy
-MYCOKEM CAPSULE should not
be
used
during
pregnancy
unless
there
is
no
suitable
alternative
treatment
to
prevent
transplant
rejection
-MYCOKEM CAPSULE should not
be
given
to
women
who
are
breastfeeding.
If any of the above apply to you (or
you are not sure), talk to your doctor
straight
away
before
taking
MYCOKEM CAPSULE.
_Taking other medicines_
Please
inform
your
doctor
or
pharmacist
if
you
are
taking/using
other medicines or have
recently taken/used other medicines,
even if these were obtained without
a
prescription.
Are
you
taking
medicines that contains
-Acyclovir, Ganciclovir (for treatment
of viral infection)
-colestyramine (for
the
treatment
of
patients with high blood cholesterol)
-
rifampicin,
norfloxacin,
metronidazole,
ciprofloxacin,
amoxicillin
+
clavulanic
acid
(antibiotic)

Ciri produk

MYCOKEM CAPSULES 250 mg
MYCOPHENOLATE MOFETIL CAPSULES USP
NAME OF PRODUCT
MYCOKEM CAPSULES 250 MG
DESCRIPTION AND COMPOSITION:
MYCOKEM CAPSULES 250 MG:
White to off white granular powder filled in size "1" blue coloured
cap, brown coloured body hard gelatin capsules imprinted "266" on body
with
black ink.
Each hard gelatin capsule contains:
Mycophenolate Mofetil Ph. Eur. .... 250 mg
PHARMACODYNAMICS
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
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
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
Mycokem is correlated with MPA concentration. The mean bioavailability
of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to
IV mycophenolate mofetil. Mycophenolate mofetil is not measurable
systemically in plasma following oral administration.
Distribution
As a result of enterohepatic recirculation, secondary increases in
plasma MPA concentration are usually observed at approximately 6 –
12
hours post-dose. A reduction in the AUC of MPA of approximately 40% is
associated with the co-administration of cholestyramine (4 g TID),
indicating that there is a significant amount of enterohepatic
recirculation. MPA at clinically relevant concentrations is 97% bound
to plasma
albumin.
Biotransformation
MPA is metabolised principally by gl