AZATHIOPRINE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Aphena Pharma Solutions - Tennessee, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Renal Homotransplantation: 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 on these variables has not been tested in controlled trials. Rheumatoid Arthritis : 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. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been

Resumen del producto:

Azathioprine Tablets USP, 50 mg Yellow, round, scored tablets (Identified 54 043) NDC 60219-1076-1: Bottles of 100 tablets. Storage Store between 15° to 25°C (59° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. PROTECT FROM LIGHT. PROTECT FROM MOISTURE.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

AZATHIOPRINE- AZATHIOPRINE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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AZATHIOPRINE TABLETS USP, 50 MG
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, USP, an immunosuppressive antimetabolite, is available
in tablet form for oral
administration. Each scored tablet contains 50 mg azathioprine, USP
and the inactive ingredients
anhydrous lactose, magnesium stearate, povidone, pregelatinized starch
(corn starch), and stearic acid.
Azathioprine, USP is chemically 1_H_-Purine,
6-[(1-methyl-4-nitro-1_H_-imidazol-5-yl)thio]-. The
structural formula of azathioprine, USP 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 insoluble in water, but may be dissolved with
addition of one molar equivalent of
alkali. Azathioprine, USP 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-azathioprine and decays with a half-life of 5 hours. This is not an
estimate of
the half-life of azathioprine itself, but is the decay rate for all
S-containing metabolites of the drug.
Because of extensive metabolism, only a fraction of the radioactivity
is prese