AZATHIOPRINE AN azathioprine 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

azathioprine, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals 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:

Licence status A

Authorization date:

2012-06-05