Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
AZATHIOPRINE SODIUM (UNII: AM94R510MS) (AZATHIOPRINE - UNII:MRK240IY2L)
Hikma Pharmaceuticals USA Inc.
AZATHIOPRINE SODIUM
AZATHIOPRINE 100 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
Azathioprine Sodium for Injection, USP 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. Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a five-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 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 ad
Azathioprine Sodium for Injection, USP, is supplied in a 20 mL vial, each containing azathioprine sodium, equivalent to 100 mg azathioprine. NDC 0143-9566-01. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. The sterile, lyophilized sodium salt is yellow, and should be dissolved in Sterile Water for Injection (see DOSAGE AND ADMINISTRATION: Parenteral Administration ). To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.
Abbreviated New Drug Application
AZATHIOPRINE SODIUM- AZATHIOPRINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- AZATHIOPRINE SODIUM FOR INJECTION, USP 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 Sodium for Injection, USP is a sterile lyophilized material, which when reconstituted with Sterile Water for Injection yields a solution for intravenous administration. Each vial contains azathioprine sodium equivalent to 100 mg azathioprine, an immunosuppressive antimetabolite. Each vial also contains sodium hydroxide and, if necessary, hydrochloric acid to adjust the pH. Azathioprine is chemically 6-[(1-methyl-4-nitroimidazol-5-yl)thio]purine. The structural formula of azathioprine sodium is: Molecular Formula: C H N O SNa Molecular Weight: 300.28 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. CLINICAL PHARMACOLOGY Azathioprine is well absorbed following oral administra Citiți documentul complet