MYCOPHENOLATE AN mycophenolate mofetil 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Mycophenolate mofetil

Authorization status:

Registered

Patient Information leaflet

Mycophenolate AN CMI v3.0
1
Mycophenolate AN
Mycophenolate Mofetil 500 mg Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mycophenolate
AN.
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
Mycophenolate AN 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 MYCOPHENOLATE AN IS
USED FOR
Mycophenolate AN contains the
active ingredient mycophenolate
mofetil.
Mycophenolate AN belongs to a
group of medicines called
immunosuppressants.
Immunosuppressants are used to
prevent rejection of transplanted
organs, and work by stopping your
immune system from reacting to
the transplanted organ.
There are many different types of
medicines used to prevent
transplant rejection.
Mycophenolate AN belongs to a
new group of these medicines.
Mycophenolate AN may be used
together with other medicines
known as cyclosporin and
corticosteroids.
Your doctor, however, may have
prescribed Mycophenolate AN for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
MYCOPHENOLATE AN HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
Mycophenolate AN is not addictive.
BEFORE YOU TAKE
MYCOPHENOLATE AN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MYCOPHENOLATE AN IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO MYCOPHENOLATE AN OR
ANY INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of face, lips,
tongue or other parts of
the body
•
rash, itching, hives on the
skin
2. YOU ARE PREGNANT.
Mycophenolate AN is harmful to an
unborn baby when taken by a
pregnant woman.
There have been cases of
miscarriage and severe b

Summary of Product characteristics

MYCOPHENOLATE AN (Mycophenolate mofetil 500 mg tablets)
Mycophenolate AN PI v3.0 Page 1 of 33
PRODUCT INFORMATION
MYCOPHENOLATE AN
(MYCOPHENOLATE MOFETIL 500 MG TABLETS)
NAME OF THE MEDICINE
Mycophenolate mofetil
CAS -128794-94-5
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic
acid.
The chemical name for mycophenolate mofetil is
2-morpholinoethyl(_E_)-6-(1,3-dihydro-4-
hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate.
It has a molecular formula of C
23
H
31
NO
7
and a molecular weight of 433.50.
DESCRIPTION
Mycophenolate mofetil is a white to off-white crystalline powder. It
is freely soluble in
dimethyl
sulfoxide,
tetrahydrofuran,
acetone,
acetonitrile,
dichloromethane,
and
ethyl
acetate;
soluble
in
methanol
and
propylene
carbonate;
sparingly
soluble
in
anhydrous
ethanol; slightly soluble in 2-propanol, diethyl ether, and very
slightly soluble in hexane. It is
practically insoluble in water (43 µg/mL at pH 7.4); the solubility
increases in acidic media
(4.27 mg/mL at pH 3.6).
Mycophenolate AN are available as purple-coloured film-coated tablets
containing 500 mg
of
mycophenolate
mofetil
with
the
excipients
microcrystalline
cellulose,
povidone,
hydroxypropylcellulose,
croscarmellose
sodium,
purified
talc
,
magnesium
stearate
and
opadry complete film coating system 03B50110 purple (PI number:
12853).
PHARMACOLOGY
MECHANISM OF ACTION
Mycophenolic acid (MPA) is a potent, selective, uncompetitive and
reversible inhibitor of
inosine monophosphate dehydrogenase (IMPDH) which inhibits the _ de
novo_ pathway of
guanosine nucleotide synthesis without incorporation into DNA. Based
on Chinese hamster
MYCOPHENOLATE AN (Mycophenolate mofetil 500 mg tablets)
Mycophenolate AN PI v3.0 Page 2 of 33
inosine-5’-monophosphate
dehydrongenase
(IMPDH)
in
complex
with
inosine-5’-
monophosphate
(IMP)
and
mycophenolic
acid
(MPA),
the
mechanism
by
which
mycophenolic acid (MPA) inhibits the enzymatic activity of IMPDH
(human type II) appears
to be related to the ability of mycophenolic acid