IMAZAN azathioprine 25mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
azathioprine, Quantity: 25 mg
Available from:
Strides Pharma Science Pty Ltd
INN (International Name):
Azathioprine
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; mannitol; maize starch; povidone; croscarmellose sodium; sodium stearylfumarate; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; iron oxide black; macrogol 400; macrogol 8000; sunset yellow FCF aluminium lake; carmine; indigo carmine aluminium lake
Administration route:
Oral
Units in package:
100 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Azathioprine is used as an immunosuppressant/antimetabolite either alone or, more commonly, in combination with the other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. Azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. Azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: Severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis,/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia and chronic refractory idiopathic thromocytopenic purpura.
Product summary:
Visual Identification: A peach coloured, film coated, circular, biconvex tablet, engraved "AZA 25" on one face, the other face is plain.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 1 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Registered
Authorization date:
2012-06-05
Patient Information leaflet
IMAZAN™
Consumer Medicine Information
Azathioprine 25 mg and 50 mg tablets
_ _
_ _
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME OF THE COMMON QUESTIONS ABOUT IMAZAN. 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 IMAZAN against
the benefits the medicine is expected to 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 IMAZAN IS USED FOR
IMAZAN contains azathioprine. This belongs to a group of medicines
called immune suppressants which
work by reducing the body’s own natural immunity.
IMAZAN is used to treat patients who have received an organ transplant
to help prevent their body from
rejecting the transplanted organs (e.g. a heart or kidney).
IMAZAN is also used to suppress the body’s immunity to treat
“autoimmune” conditions like rheumatoid
arthritis, systemic lupus erythematosus or chronic active hepatitis..
IMAZAN may also be used to treat other conditions as determined by
your doctor.
IMAZAN IS A VERY POWERFUL MEDICINE. NEVER LET ANYONE ELSE TAKE YOUR
MEDICINE EVEN IF HIS OR HER
CONDITION SEEMS SIMILAR TO YOURS.
HAVE REGULAR CHECK UPS WITH YOUR DOCTOR.
IMAZAN TABLETS ARE NOT ADDICTIVE.
BEFORE YOU TAKE IMAZAN
_ _
_WHEN YOU MUST NOT TAKE IT: _
IF YOU ARE FEMALE AND YOU ARE PREGNANT OR THERE IS A CHANCE THAT YOU
MAY BECOME PREGNANT; OR IF
YOU ARE MALE AND THERE IS A CHANCE THAT YOU MAY FATHER A CHILD.
IMAZAN is not recommended during pregnancy. IT MAY CAUSE BIRTH DEFECTS
IF EITHER THE MALE OR
FEMALE ARE USING IT AT THE TIME OF CONCEPTION.
Your partner should take adequate contraceptive precautions while you
are taking IMAZAN.
IF YOU ARE BREASTFEEDING OR ARE PLANNING TO BREASTFEED.
IMAZAN passes into breast milk and may cause serious side effects to
your baby.
IF YOU ARE TAKING ANY OTHER MEDICINES OR DRUGS.
Read the complete document
Summary of Product characteristics
Page 1 of 11
PRODUCT INFORMATION
IMAZAN
25 MG & 50 MG
TABLETS
NAME OF THE MEDICINE
The active ingredient in IMAZAN is azathioprine.
Chemical structure:
_ _
Chemical formula:C
9
H
7
N
7
O
2
S
CAS no.: 446-86-6
Chemical name:
6-[(1-methyl-4-nitro-1_H_-imidazol-5-yl)thio]-7_H_-purine.
Molecular weight: 277.3.
DESCRIPTION
Azathioprine is a pale yellow powder. It is practically insoluble in
water or ethanol (96%). It is
soluble in dilute solutions of alkali hydroxides and sparingly soluble
in dilute mineral acids.
IMAZAN tablets also contain the following ingredients:
microcrystalline cellulose,
croscarmellose sodium, mannitol, povidone, sodium stearylfumarate,
maize starch and
25 mg only: Opadry Buff OY-3682, Opadry Buff OY-3690 and Opadry
OY-1315G.
50 mg only: Opadry clear OY-7240.
PHARMACOLOGY
Azathioprine is an imidazole derivative of 6-mercaptopurine (6-MP). It
is rapidly broken
down _in-vivo _into 6-MP and a methylnitro-imidazole moiety. The 6-MP
readily crosses cell
membranes and is converted intracellularly into a number of purine
thioanalogues, which
include the main active nucleotide, thioinosinic acid. The rate of
conversion varies from
one person to another. Nucleotides do not transverse cell membranes
and therefore do
not circulate in body fluids.
Irrespective of whether it is given directly or is derived _in-vivo
_from azathioprine, 6-MP is
eliminated mainly as the inactive oxidised metabolite thiouric acid.
This oxidation is
brought about by xanthine oxidase, an enzyme that is inhibited by
allopurinol. The
activity of the methylnitroimidazole moiety has not been defined
clearly. However, in
Page 2 of 11
several systems it appears to modify the activity of azathioprine as
compared with that of
6-MP.
The determination of azathioprine or 6-MP plasma concentrations has no
prognostic
value as regards effectiveness or toxicity of these compounds.
While the precise mode of action remains to be elucidated, some
suggested mechanisms
include:
The release of 6-MP which acts as a purine antimetabolite;
The
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