Concise Prescribing Info
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment w/ other immunosuppressants in adults.
Dosage/Direction for Use
Prophylaxis of kidney transplant rejection Initially 0.2-0.3 mg/kg/day once daily in the morning w/in 24 hr after surgery. Prophylaxis of liver transplant rejection Initially 0.1-0.2 mg/kg/day once daily in the morning approx 12-18 hr after the completion of surgery. Allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily tacrolimus monohydrate, treatment should begin w/ the initial oral dose recommended in kidney & liver transplantation respectively for prophylaxis of transplant rejection. Allograft rejection after heart transplantation Adult In those converted to tacrolimus monohydrate, initially 0.15 mg/kg/day once daily in the morning. Allograft rejection after transplantation of other allografts Lung-transplanted patient Initially 0.10-0.15 mg/kg/day; pancreas-transplanted patient Initially 0.2 mg/kg/day; intestinal transplantation Initially 0.3 mg/kg/day.
Should be taken on an empty stomach: Take in the morning. Swallow whole w/ water 1 hr before or 2-3 hr after meal.
Hypersensitivity to tacrolimus & to other macrolides.
Special Precautions
Maintain the patients on a single formulation of tacrolimus w/ the corresponding daily dosing regimen. Treatment w/ other immunosuppressive medicinal products; prophylaxis of transplant rejection in heart allograft recipients. Monitor the following during the initial post-transplant period: BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), liver & renal function tests, hematology parameters, coagulation values & plasma protein determinations. Concomitant use w/ strong CYP3A4 inhibitors/inducers; St. John's wort-containing herbal prep; ciclosporin (avoid in patients previously receiving ciclosporin); high K or K-sparing diuretic therapy; nephrotoxic or neurotoxic drugs; live attenuated vaccines. Significant change in blood levels during diarrhea episodes. Increased risk of cardiac disorders in pre-existing heart disease, corticosteroid usage, HTN, renal or hepatic dysfunction, infections, fluid overload & oedema. May prolong QT interval, caution in patients w/ diagnosed or suspected congenital long QT syndrome. May increase risk of lymphoproliferative disorders & malignancies when in concomitant w/ immunosuppressives eg, antilymphocytic antibodies. Limit exposure to sunlight & UV light. Increased risk for opportunistic infections eg, BK virus-associated nephropathy & JC virus-associated progressive multifocal leukoencephalopathy. Monitor symptoms of posterior reversible encephalopathy syndrome. Non-Caucasians & those at elevated immunological risk; severe liver impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hypersensitivity to peanut or soya. May affect ability to drive or operate machinery. Pregnancy. Do not use in lactation. Childn <18 yr.
Adverse Reactions
Headache, tremor; diarrhoea, nausea; renal impairment; DM, hyperglycaemic conditions, hyperkalaemia; abnormal liver function test; HTN; insomnia.
Drug Interactions
Increased blood levels w/ CYP3A4 inhibitors (eg, ketoconazole, fluconazole, itraconazole, voriconazole, erythromycin, HIV PIs; clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole, nefazodone. Potential metabolism inhibition w/ bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin; grapefruit juice; lansoprazol, ciclosporin. Potentially increase blood levels w/ NSAIDs, oral anticoagulants/antidiabetics; prokinetic agents (eg, metoclopramide & cisapride), cimetidine & Mg-Al hydroxide. Decreased blood levels w/ CYP3A4 inducers (eg, rifampicin, phenytoin, St. John's wort, phenobarb, corticosteroids; carbamazepine, metamizole & INH). Increased or decreased blood levels w/ high-dose prednisolone or methylprednisolone for the treatment of acute rejection. Prolonged t½ of ciclosporin; increased blood level of phenytoin; reduced clearance of steroid-based contraceptives. May potentially decrease clearance & increase t½ of pentobarbital & antipyrine. Increased nephrotoxic or neurotoxic effects w/ aminoglycosides, gyrase inhibitors, vancomycin, co-trimoxazole, NSAIDs, ganciclovir or acyclovir. Enhanced nephrotoxicity w/ amphotericin B & ibuprofen. Risk of hyperkalemia w/ high K intake or K-sparing diuretics (eg, amiloride, triamterene or spironolactone). Avoid administration of live attenuated vaccines. Enhanced visual & neurological disturbances w/ alcohol.
MIMS Class
ATC Classification
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
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