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AZASAN®
(azathioprine) 75 mg, 100 mg Scored Tablets , USP
WARNING
Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. 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. See WARNINGS.
AZASAN® (azathioprine) , an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 75 mg or 100 mg azathioprine and the inactive ingredients lactose monohydrate, pregelatinized starch, povidone, corn starch, magnesium stearate, and stearic acid.
Azathioprine is chemically 1H-purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-. The structural formula of azathioprine is:
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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. The sodium salt of azathioprine is sufficiently soluble to make a 10 mg/mL water solution which is stable for 24 hours at 59° to 77°F (15° to 25°C). 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.
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.
Call your doctor at once if you have a serious side effect such as:
Read All Potential Side Effects and See Pictures of Azasan »
Before taking azathioprine, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood disorders, decreased bone marrow function, history of cancer (such as lymphoma), active infections, certain enzyme disorder (TPMT deficiency).
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.
Since this medication can increase...
Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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