Azathioprine Sodium
AZATHIOPRINE SODIUM FOR INJECTION, USP
9ffe79a1-ac91-4a7b-a9e3-7c84bfa9ddf0
HUMAN PRESCRIPTION DRUG LABEL
May 15, 2023
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azathioprine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
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.
Renal Homotransplantation
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.
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.