AZATHIOPRINE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aphena Pharma Solutions - Tennessee, LLC

INN (nemzetközi neve):

AZATHIOPRINE

Összetétel:

AZATHIOPRINE 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 add

Termék összefoglaló:

Azathioprine Tablets USP, 50 mg are round, yellow, flat faced tablets debossed with A to the left of the score and Z to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1005-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AZATHIOPRINE- AZATHIOPRINE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 tablets. See WARNINGS.
DESCRIPTION
Azathioprine tablets USP, an immunosuppressive antimetabolite, is
available in tablet form for oral
administration. Each scored tablet contains 50 mg azathioprine, USP
and the inactive ingredients corn
starch, lactose monohydrate, magnesium stearate, 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:
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.
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