AZATHIOPRINE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Amneal Pharmaceuticals NY LLC

INN (International namn):

AZATHIOPRINE

Sammansättning:

AZATHIOPRINE 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 studied for either added benefit or unexpected adverse effects. The use of azathioprine tablets with these agents cannot be recommended. Azathioprine tablets should not be given to patients who have shown hypersensitivity to the drug. Azathioprine tablets should not be used for treating rheumatoid arthritis in pregnant women. Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan, or others) may have a prohibitive risk of malignancy if treated with azathioprine tablets.

Produktsammanfattning:

Azathioprine Tablets USP, 50 mg is supplied as yellow round tablet, scored on one side and product identification code "54 043" debossed on the other side. Bottles of 100:                                                 NDC 60219-1076-1 Azathioprine Tablets USP, 75 mg is supplied as yellow round tablets, scored on one side and debossed with "AA 44" on the other side. Bottles of 100:                                                   NDC 60219-2036-1 Azathioprine Tablets USP, 100 mg is supplied as yellow round tablets, scored on one side and debossed with "AA 45" on the other side. Bottles of 100:                                                   NDC 60219-2037-1 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AZATHIOPRINE- AZATHIOPRINE TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
AZATHIOPRINE TABLETS, USP
(50 MG, 75 MG AND 100 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, 75 mg or 100 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 ra