Use this medicine (azathioprine tablets) as ordered by your doctor.
They are supplied as follows:Carton of 100 (10 x 10) Unit-dose Tablets: NDC 67877-493-38Azathioprine 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. Among patients of East Asian ancestry (i.e., Chinese, Japanese, Vietnamese), 2% have two loss-of-function alleles of the NUDT15 gene, and approximately 21% have one loss-of-function allele.
Withdrawal of an effective dose in certain circumstances, e.g. However, the proportion of the increased risk attributable to the azathioprine dosage or to other therapies (i.e., alkylating agents) received by patients treated with azathioprine cannot be determined.Hepatotoxicity manifest by elevation of serum alkaline phosphatase, bilirubin, and/or serum transaminases is known to occur following azathioprine use, primarily in allograft recipients. The relationship between alopecia and azathioprine treatment is uncertain.Stevens-Johnson syndrome and toxic epidermal necrolysis.Several different clinical syndromes, which appear to be idiosyncratic manifestations of hypersensitivity, have been described occasionally following administration of Azathioprine.
Only a small amount of the dose of azathioprine administered is excreted unmetabolised in the urine.Store in a dry place below 25°C. The inhibition of xanthine oxidase in patients receiving allopurinol (ZYLOPRIM®) is the basis for the azathioprine dosage reduction required in these patients (see The use of azathioprine for inhibition of renal homograft rejection is well established, the mechanism(s) for this action are somewhat obscure. 67877-495-38 67877-492-33, In transplant patients, consider the risk that the reduced immunosuppression represents to the graft.Azathioprine has been reported to cause temporary depression in spermatogenesis and reduction in sperm viability and sperm count in mice at doses 10 times the human therapeutic dose;Azathioprine is teratogenic in rabbits and mice when given in doses equivalent to the human dose (5 mg/kg daily). 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. Consider the diagnosis of PML in any patient presenting with new-onset neurological manifestations and consider consultation with a neurologist as clinically indicated. Hematologic toxicities are dose-related and may be more severe in renal transplant patients whose homograft is undergoing rejection. Use with Angiotensin-Converting Enzyme Inhibitors: To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchTPMT TESTING CANNOT SUBSTITUTE FOR COMPLETE BLOOD COUNT (CBC) MONITORING IN PATIENTS RECEIVING AZATHIOPRINE
Azathioprine is immunosuppressive, delayed hypersensitivity and cellular cytotoxicity tests being suppressed to a greater degree than are antibody responses. 67877-494-38, In one completed study, the rate of lymphoproliferative disease in RA patients receiving higher than recommended doses of azathioprine (5 mg/kg per day) was 1.8 cases per 1000 patient-years of follow-up, compared with 0.8 cases per 1000 patient-years of follow-up in those not receiving azathioprine. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.Use with Angiotensin-Converting Enzyme Inhibitors: Store at 20°C to 25°C (68° to 77°F), (see USP Controlled Room Temperature) in a dry place and protect from light. Read all information given to you. Azathioprine is used in the treatment of patients exhibiting the following conditions, where it has been shown to have a marked therapeutic effect: chronic active hepatitis, severe rheumatoid arthritis, systemic lupus erythematosus (SLE), idiopathic thrombocytopenic purpura, acquired haemolytic anaemia and severe cases of specified dermatological diseases (pemphigus vulgaris, dermatomyositis, polyarteritis …