INDICATIONS AND USAGE 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. Renal Homotransplantation: 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 on these variables has not been tested in controlled trials. Rheumatoid Arthritis: 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. 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 tablets with these agents cannot be recommended.
amneal pharmaceuticals ny llc
AZATHIOPRINE Tablets USP, 50 mg yellow, round, scored tablets (Identified 54 043). Bottle of 100 Tablets: NDC 69238-1076-1 Store at 20Â° to 25Â°C (68Â° to 77Â°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT FROM LIGHT. PROTECT FROM MOISTURE.
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