AZATHIOPRINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AZATHIOPRINE

Composition:

AZATHIOPRINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine tablets on these variables has not been tested in controlled trials. Azathioprine tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine tablets. The combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added be

Product summary:

Azathioprine Tablets USP, 50 mg are yellow, round, flat, beveled edge tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "59" and other side is plain and are supplied as follows: Bottles of 180 Bottles of 270 NDC 54868-5310-6 NDC 54868-5310-5 Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature] in a dry place and protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZATHIOPRINE - AZATHIOPRINE TABLET
PHYSICIANS TOTAL CARE, INC.
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AZATHIOPRINE TABLETS, USP
BOXED WARNING
WARNING - MALIGNANCY
Chronic immunosuppression with azathioprine, 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 azathioprine. See WARNINGS.
DESCRIPTION
Azathioprine is an immunosuppressive antimetabolite. Each uncoated
azathioprine tablet intended for
oral administration contains 50 mg of azathioprine. In addition, each
tablet contains the following
inactive ingredients: croscarmellose sodium, lactose monohydrate,
magnesium stearate, povidone and
starch.
Azathioprine is chemically
6-[(1-methyl-4-nitro-_1H_-imidazol-5-yl)thio]-_1H_-purine. The
structural
formula of azathioprine is:
It is an imidazolyl derivative of 6-mercaptopurine and many of its
biological effects are similar to those
of the parent compound.
Azathioprine, USP is a pale yellow, odorless powder. It is insoluble
in water, soluble in dilute
solutions of alkali hydroxides, sparingly soluble in dilute mineral
acids, very slightly soluble in alcohol
and in chloroform. 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.
CLINICAL PHARMACOLOGY
Azathioprine is well absorbed following oral administration. Maximum
serum radioactivity occurs at 1
to 2 hours after oral
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