Imuran


IMURAN

(azathioprine) 50-mg Scored Tablets



WARNING



MALIGNANCY



Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN. See WARNINGS.



DESCRIPTION



IMURAN (azathioprine), an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 50 mg azathioprine and the inactive ingredients lactose, magnesium stearate, potato starch, povidone, and stearic acid.



Azathioprine is chemically 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine. The structural formula of azathioprine is:



IMURAN (azathioprine) Structural Formula Illustration

It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound.



Azathioprine is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide.



For Consumers

What are the possible side effects of azathioprine (Azasan, Imuran)?



Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.



Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:



fever, night sweats, weight loss, tiredness;

feeling full after eating only a small amount;

pain in your upper stomach that may spread to your shoulder;

easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or

nausea,...

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