AZATHIOPRINE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Amneal Pharmaceuticals NY LLC

INN (Међународно име):

AZATHIOPRINE

Састав:

AZATHIOPRINE 50 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Azathioprine Tablets USP, 50 mg Yellow, round, scored tablets (Identified 54 043). Bottle of 100 Tablets:                                                 NDC 69238-1076-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT FROM LIGHT. PROTECT FROM MOISTURE.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

AZATHIOPRINE- AZATHIOPRINE TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
AZATHIOPRINE TABLETS, USP
(50 MG)
RX ONLY
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, 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 is chemically 1_H_-Purine,
6-[(1-methyl-4-nitro-1_H_-imidazol-5-yl)thio]-. 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 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 present as azathiopr