Seegraf Capsules (Tacrolimus)

• Composition :
  Each capsule contains Tacrolimus 0.5 mg/1 mg/2 mg.
• Indications :
  Indicated for Prophylaxis of transplant rejection in adult kidney or liver allograft rejection. Lupus Nephritis.
• Pharmacodynamics :
  Tacrolimus is a calcineurin-inhibitor immunosuppressant which inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus - FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited.
• Dosage and administration :
  The initial dose of Seegraf should be administered no sooner than 6 hours after transplantation in the liver and heart transplant patients. In kidney transplant patients, the initial dose of Seegraf may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered. Administer capsules consistently with or without food; do not drink grapefruit juice.
• Contraindications :
  Seegraf is contraindicated in patients with a hypersensitivity to tacrolimus.
• Precautions and warnings :
  Patients receiving immunosuppressants, including Seegraf, are at increased risk of developing lymphomas and other malignancies, particularly of the skin, increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. Blood glucose concentrations should be monitored closely in patients using Seegraf. New onset diabetes, nephrotoxicity, neurotoxicity, hyperkalaemia & hypertension.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy: Based on animal data may cause fetal harm. Use only if the potential benefit justifies the risk. Nursing Mothers: Discontinue nursing taking into consideration importance of drug to mother.
• Drug interactions :
  Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to Seegraf; monitor for MPA-related adverse reactions and adjust MMF or MPA-dose as needed, CYP3A Inhibitors: Increased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed with concomitant use.
• Adverse reactions :
  The most common adverse reactions were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, anemia hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia.
• Therapy Area :
  Immunosuppresants