AZATHIOPRINE- azathioprine tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Διεθνής Όνομα):

AZATHIOPRINE

Σύνθεση:

AZATHIOPRINE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 USP 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. Azathioprine Tablets USP 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 une

Περίληψη προϊόντος:

Azathioprine Tablets USP, 50 mg Yellow, round, scored tablets (Identified 54 043) NDC 0615-7568-39 Blisterpacks of 30 Tablets. Store between 15°-25°C (59°-77°F). Dispense in a tight, light-resistant container as defined in the USP/NF. PROTECT FROM LIGHT. PROTECT FROM MOISTURE.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AZATHIOPRINE- AZATHIOPRINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
AZATHIOPRINE TABLETS USP, 50 MG
RX ONLY
WARNING: Chronic immunosuppression with this purine antimetabolite
increases_ risk of_
_neoplasia_ in humans. 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. 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.
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.
Azathioprine is chemically 1_H_-Purine,
6-[(1-methyl-4-nitro-1_H_-imidazol-5-yl)thio]-. The structural
formula of azathioprine is:
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 azathioprine, and of mercaptopurine
derived from i