Azoran-50mg Tablets

Class: Immunosuppressive Action Suppresses cell-mediated hypersensitivities; alters antibody production and may reduce inflammation. Indications Adjunct for prevention of rejection in renal homotransplantation; treatment in adults for severe, active, erosive rheumatoid arthritis not responsive to conventional management. Unlabeled use(s): Treatment of chronic ulcerative colitis, Crohn's disease, myasthenia gravis and Behcet's syndrome. Contraindications Pregnancy in patients with rheumatoid arthritis. Route/Dosage Renal Transplantation ADULTS & CHILDREN: IV/PO Initiate with 3 to 5 mg/kg/day as single daily dose. Maintenance levels are 1 to 3 mg/kg/day. Rheumatoid Arthritis ADULTS: PO Initial dose is 1 mg/kg given as single dose or twice daily. Dose is increased by 0.5 mg/kg/day at 6 to 8 wk, then every 4 wk if there are no serious toxicities and if initial response is unsatisfactory. Max dose is 2.5 mg/kg/day. IV Reserved for patients unable to tolerate oral medications. Interactions Allopurinol: Decreases metabolism of azathioprine. Dose of azathioprine is reduced to approximately one-third to one-fourth usual dose when used concomitantly. Nondepolarizing muscle relaxants (eg, tubocurarine, pancuronium): Azathioprine may resist or reverse neuromuscular blockade. Lab Test Interferences None well documented. Adverse Reactions DERM: Rash. GI: Nausea; vomiting. HEMA: Leukopenia; thrombocytopenia; macrocytic anemia; bleeding; selective erythrocyte aplasia. OTHER: Serious infections; neoplasias. Precautions Pregnancy: Category D. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Carcinogenesis/mutagenesis: Chronic immunosuppression with azathioprine increases risk of neoplasia. Patients with rheumatoid arthritis previously treated with alkylating agents (eg, cyclophosphamide, chlorambucil, melphalan) may have prohibitive risk of neoplasia. GI toxicity: Hypersensitivity reaction with severe nausea and vomiting may occur. Frequency of gastric disturbances can be reduced by giving in divided doses or after meals. Hematologic effects: Severe hematologic toxicities may occur; monitor blood counts. Hepatoxicity: Occurs primarily in allograft recipients. Rare but life-threatening hepatic veno-occlusive disease has occurred in transplant patients; monitor liver function tests. Superinfection: Serious fungal, viral, bacterial and protozoal infections may develop in patients on long-term immunosuppression. PATIENT CARE CONSIDERATIONS Administration/Storage Do not vigorously shake solution when reconstituting IV preparations. Divide daily dosage to reduce GI upset. Administer with food or immediately after meals. Store in a tightly-closed container in a cool location. Discard reconstituted IV preparations after 24 hr. Follow any procedures required for proper disposal of immunosuppressant/antimetabolite. Assessment/Interventions Obtain patient history, including drug history and any known allergies. Review baseline CBC, renal studies and liver studies. Assess for signs of infection before administration. Monitor I&O and daily weight during therapy. Monitor patient for signs of superinfection during therapy. Notify physician if patient displays sudden, severe dyspnea, bleeding from the gums or mucous membranes or blood in urine or stools. OVERDOSAGE: SIGNS & SYMPTOMS Bone marrow hypoplasia, bleeding, infection, death Patient/Family Education Instruct patient that if once-daily dose is forgotten to skip the dose, but if 2 daily doses are missed to call the physician. Next dose may be doubled. Explain importance of precautions regarding contact with individuals who have active infections and individuals who have recently received oral polio vaccine. Identify signs of transplant rejection (eg, localized redness, tenderness and swelling in the area of the transplant, decreased transplant organ function), and remind patient that this or similar medication will be required indefinitely to prevent transplant rejection. Explain that frequent follow-up appointments with a physician are important to adjust medication dosage. Instruct patient to report the following symptoms to physician: Unusual bleeding, decreased urine output, abdominal pain. Caution patient not to take otc medications without consulting physician