GN-AZATHIOPRINE azathioprine 25mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Send request.
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 rheumetoid 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:
Licence status A
Authorization date:
2012-06-05
Summary of Product characteristics
Page 1 of 11
PRODUCT INFORMATION
GN-AZATHIOPRINE
25 MG & 50 MG
TABLETS
NAME OF THE MEDICINE
The active ingredient in GN-AZATHIOPRINE 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.
GN-AZATHIOPRINE 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 puri
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