AZATHIOPRINE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Glenmark Pharmaceuticals, Inc

INN (Alþjóðlegt nafn):

AZATHIOPRINE

Samsetning:

AZATHIOPRINE 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

INDICATIONS AND USAGE: 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 Tablets on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine isTablets 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 added benefit or unexpected adverse effects. The use of azathioprine with these agents cannot be recommended. CONTRAINDICATIONS: 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.

Vörulýsing:

HOW SUPPLIED: Azathioprine Tablets, USP, 50 mg are capsule-shaped, yellow, scored tablets, bottles of 100 (NDC 68462-502-01). 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.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

AZATHIOPRINE- AZATHIOPRINE TABLET
GLENMARK PHARMACEUTICALS, INC
----------
AZATHIOPRINE TABLETS, 50MG
WARNING: _MALIGNANCY_Chronic immunosuppression with Azathiorprine
Tablets, 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, an immunosuppressive antimetabolite, is
available in tablet form for
oral administration. Each scored tablet contains 50 mg azathioprine
and the inactive
ingredients lactose monohydrate, pregelatinized starch, povidone, corn
starch,
magnesium stearate, and stearic acid.
Azathioprine is chemically 1H-purine, 6-[(1-methyl-4-nitro-
1H-imidazol-5-yl)thio]-1 _H_-
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. 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 of the drug. Because of extensive metabolism,
only a fraction
of the radioactivity is present as az