Composition
Cap 0.5 mg/1 mg/5 mg: Tacrolimus 0.5 mg/1 mg/5 mg.
Indications & Dosage
Prophylaxis of graft rejection following liver transplantation, starting 12 hours after transplantation: Adult: Initially 100-200 mcg/kg daily in 2 divided doses. Prophylaxis of graft rejection following kidney transplantation, starting within 24 hours of transplantation: Adult: Initially 200-300 mcg/kg daily in 2 divided doses. Prophylaxis of graft rejection following heart transplantation following antibody induction, starting within 5 days of transplantation: Adult: Initially 75 mcg/kg daily in 2 divided doses. Prophylaxis of graft rejection following heart transplantation without antibody induction, starting within 12 hours of transplantation: Adult: Initially 75 mcg/kg daily in 2 divided doses. Allograft rejection resistant to conventional immunosuppressive therapy: Adult: Consult product literature or seek specialist advice.
Contraindications
Avoid concurrent administration with ciclosporin (care if patient has previously received ciclosporin).
Precautions
Increased risk of infections, lymphoproliferative disorders, malignancies, neurotoxicity, QT-interval prolongation, UV light (avoid excessive exposure to sunlight and sunlamps). Cardiomyopathy has been reported in children given tacrolimus after transplantation. Patients should be monitored carefully by echocardiography for hypertrophic changes; dose reduction or discontinuation should be considered if these occur. Monitor visual status, blood glucose, haematological and neurological parameters and whole blood 'trough' concentrations of tacrolimus (especially during episodes of diarrhoea), may affect performance of skilled tasks (e.g. driving).
Side Effects
Alopecia, anaemia, anorexia, anxiety, arthralgia, ascites, bile-duct abnormalities, blood disorders, cholestasis, convulsion, confusion, depression, dizziness, dyspnea, electrolyte disturbances, GI disturbance including dyspepsia, inflammatory and ulcerative disorders, haemorrhage, hepatic dysfunction, hyperglycaemia, hyperkalaemia, hypertension, hyperuricaemia, hypokalaemia, impaired hearing, insomnia, ischaemic events, jaundice, leucopenia, mood changes, muscle cramp, oedema, pancytopenia, paraesthesia, parenchymal lung disorders, peripheral neuropathy, photophobia, pleural effusion, psychosis, renal failure and impairment, renal tubular necrosis, seizures, sleep disturbances, sweating, tachycardia, thrombocytopenia, thromboembolic events, tinnitus, tremor, urinary abnormalities, visual disturbances, weight changes, amnesia, arrhythmia, cardiac arrest, cardiomyopathy, cataract, cerebrovascular accident, coagulation disorders, coma, haemolytic anaemia, pure red cell aplasia, myasthenia, hirsutism. Rare: Stevens-Johnson syndrome.