Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)
NCS HealthCare of KY, Inc dba Vangard Labs
AZATHIOPRINE
AZATHIOPRINE 50 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Preberite celoten dokument