Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
azathioprine, Quantity: 50 mg
Strides Pharma Science Pty Ltd
Azathioprine
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; mannitol; maize starch; povidone; croscarmellose sodium; sodium stearylfumarate; hypromellose; macrogol 400
Oral
100 tablets
(S4) Prescription Only Medicine
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 thrombocytopenic purpura.
Visual Identification: A Light yellow, circular, biconvex tablet engraved "AZA" breakline "50" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-06-05
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 read_full_document