AZATHIOPRINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Glenmark Pharmaceuticals, Inc

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

INDICATIONS AND USAGE: Azathioprine is 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 is 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 is 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

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AZATHIOPRINE- AZATHIOPRINE TABLET
GLENMARK PHARMACEUTICALS, INC
----------
AZATHIOPRINE TABLETS, 50 MG
WARNING: _MALIGNANCY_Chronic immunosuppression with this 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 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]-. 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 azathioprine. Usual doses produce
blood levels of