AZATHIOPRINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

AZATHIOPRINE

Composition:

AZATHIOPRINE 50

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azathioprine tablets, USP 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, USP 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, USP 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

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: NDC 68382-003-01 in bottles of 100 tablets NDC 68382-003-05 in bottles of 500 tablets Store at 20°C to 25° C (68°F 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
ZYDUS PHARMACEUTICALS USA 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
S-aza