AZATHIOPRINE- azathioprine tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Rebel Distributors Corp..

INN (Διεθνής Όνομα):

AZATHIOPRINE

Σύνθεση:

AZATHIOPRINE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. 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. 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 tablets. The combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added be

Περίληψη προϊόντος:

Azathioprine Tablets USP, 50 mg are yellow, round, flat, beveled edge tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "59" and other side is plain and are supplied as follows: NDC 21695-484-75 in bottles of 75 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature] in a dry place and protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AZATHIOPRINE - AZATHIOPRINE TABLET
REBEL DISTRIBUTORS CORP..
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AZATHIOPRINE TABLETS USP
BOXED WARNING
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 is an immunosuppressive antimetabolite. Each uncoated
azathioprine tablet intended for
oral administration contains 50 mg of azathioprine. In addition, each
tablet contains the following
inactive ingredients: croscarmellose sodium, lactose monohydrate,
magnesium stearate, povidone and
starch.
Azathioprine is chemically
6-[(1-methyl-4-nitro-_1H_-imidazol-5-yl)thio]-_1H_-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 a pale yellow, odorless powder. It is insoluble in
water, soluble in dilute solutions of
alkali hydroxides, sparingly soluble in dilute mineral acids, very
slightly soluble in alcohol and in
chloroform. 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.
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.
35
35
Because of extensive metabolism, only a fraction of the radioac