AZATHIOPRINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

REMEDYREPACK INC.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 studied for either added benefit or unexpected adverse effects. The use of azathioprine with these agents cannot be recommended. Azathioprine should not be given to patients who have shown hypersensitivity to the drug. Azathioprin 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.

Proizvod sažetak:

Azathioprine Tablets, USP 50 mg are overlapping circular-shaped, yellow to off white uncoated tablet, scored, debossed with "AZA" on left side of score line and "50" on right side of the score line, and plain on the other side. They are supplied as follows: NDC: 70518-3544-00 NDC: 70518-3544-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20°C to 25°C (68° to 77°F), (see USP Controlled Room Temperature) in a dry place and protect from light. Dispense in tight, light-resistant container as defined in the USP. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

AZATHIOPRINE- AZATHIOPRINE TABLET
REMEDYREPACK INC.
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AZATHIOPRINE TABLETS, USP
SCORED TABLETS
PRODUCT INFORMATION
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 25 mg, 50 mg, 75 mg and
100 mg
azathioprine and the inactive ingredients croscarmellose sodium,
lactose monohydrate,
magnesium stearate, maize starch and povidone K30.
Azathioprine is chemically 6-[(1-methyl-4-nitro-1
_H_-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.
FDA approved dissolution test specifications differ from USP.
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 extens