Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)
Ascend Laboratories, LLC
ORAL
PRESCRIPTION DRUG
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 be
Azathioprine Tablets, USP 25 mg are round, yellow to off white uncoated tablet, scored, debossed with "AZA" on upper side of score line and "25" on lower side of the score line, and plain on the other side. They are supplied as follows: Bottle of 100: NDC 67877-492-01 Bottle of 500: NDC 67877-492-05 Bottle of 1000: NDC 67877-492-10 Carton of 14 (1 x 14) Unit-dose Tablets: NDC 67877-492-14 Carton of 100 (10 x 10) Unit-dose Tablets: NDC 67877-492-38 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: Bottle of 100: NDC 67877-493-01 Bottle of 500: NDC 67877-493-05 Bottle of 1000: NDC 67877-493-10 Carton of 100 (10 x 10) Unit-dose Tablets: NDC 67877-493-38 Azathioprine Tablets, USP 75 mg are capsule shaped, yellow to off white uncoated tablet, scored, debossed with "AZA" on left side of score line and "75" on right side of the score line, and plain on the other side. They are supplied as follows: Bottle of 100: NDC 67877-494-01 Bottle of 500: NDC 67877-494-05 Bottle of 1000: NDC 67877-494-10 Carton of 100 (10 x 10) Unit-dose Tablets: NDC 67877-494-38 Azathioprine Tablets, USP 100 mg are capsule shaped, yellow to off white uncoated tablet, scored, debossed with "AZA" on left side of score line and "100" on right side of the score line, and plain on the other side. They are supplied as follows: Bottle of 100: NDC 67877-495-01 Bottle of 500: NDC 67877-495-05 Bottle of 1000: NDC 67877-495-10 Carton of 100 (10 x 10) Unit-dose Tablets: NDC 67877-495-38 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.
Abbreviated New Drug Application
AZATHIOPRINE - AZATHIOPRINE TABLET ASCEND LABORATORIES, LLC ---------- 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 Lestu allt skjalið