Tacrolimus ER Teva

Tacrolimus

Allograft rejection resistant to treatment w/ other immunosuppressive medicinal products in adults. Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.

Prophylaxis of kidney transplant rejection, treatment of allograft rejection after kidney transplantation Initially 0.2-0.3 mg/kg once daily in the morning w/in 24 hr after completion of surgery. Prophylaxis of liver transplant rejection, treatment of allograft rejection after liver transplantation Initially 0.1-0.2 mg/kg once daily in the morning 12-18 hr after completion of surgery. Allograft rejection after heart transplantation Initially 0.15 mg/kg once daily in the morning. Allograft rejection after transplantation of other allografts Initially 0.1-0.15 mg/kg daily in lung-transplanted patients, 0.2 mg/kg daily in pancreas-transplanted patients, 0.3 mg/kg daily in intestinal transplantation.

Should be taken on an empty stomach: Take in the morning. Swallow whole w/ fluid (preferably water). Avoid grapefruit & grapefruit juice. Take immediately after removal from the blister.

Hypersensitivity to tacrolimus & other macrolides.

GI disorders; pure red cell aplasia; risk factors for QT prolongation including patients w/ personal or family history of QT prolongation, CHF, bradyarrhythmia, electrolyte abnormalities, diagnosed or suspected congenital long QT syndrome or acquired QT prolongation; lymphoproliferative disorders & malignancies; posterior reversible encephalopathy syndrome. Increased risk of opportunistic infections eg, BK virus-associated nephropathy, JC virus-associated progressive multifocal leukoencephalopathy, viral hepatitis. Monitor BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), hepatic & renal function tests, haematology parameters, coagulation values & plasma protein determinations, EBV-PCR during initial post-transplant period. Concomitant use w/ strong CYP3A4 inhibitors/inducers, nephrotoxic or neurotoxic drugs; drugs prolonging QT interval, inducing electrolyte abnormalities or increasing tacrolimus exposure. Avoid use w/ St. John's wort-containing herbal prep, ciclosporin, high K or K-sparing diuretic therapy, live attenuated vaccines. Limit sun & UV light exposure. Black & non-Caucasian patients; patients at elevated immunological risk. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Renal & severe hepatic impairment. May affect male fertility. Pregnancy. Not to be used during lactation. Not recommended in childn <18 yr.

DM, hyperglycaemic conditions, hyperkalaemia; insomnia; headache, tremor; HTN; diarrhoea, nausea; renal impairment; abnormal LFTs. Anaemia, thrombocytopenia, leukopenia, abnormal RBC analyses; metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, decreased appetite, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia; confusion & disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders & disturbances, nightmare; nervous system disorders, seizures, consciousness disturbances, peripheral neuropathies, dizziness, paraesthesias & dysaesthesias, impaired writing; eye disorders, blurred vision, photophobia; tinnitus; ischaemic CAD, tachycardia; thromboembolic & ischaemic events, vascular hypotensive & peripheral vascular disorders, haemorrhage; parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion & inflammation; vomiting, abdominal pain, GI pain, inflammatory conditions, haemorrhages, ulceration & perforation, ascites, stomatitis & ulceration, constipation, dyspeptic signs & symptoms, flatulence, bloating & distension, loose stools; bile duct disorders, hepatocellular damage & hepatitis, cholestasis & jaundice; rash, pruritus, alopecia, acne, increased sweating; arthralgia, back pain, muscles spasms, limb pain; renal failure, acute renal failure, toxic nephropathy, renal tubular necrosis, urinary abnormalities, oliguria, bladder & urethral symptoms; febrile disorders, pain & discomfort, asthenic conditions, oedema, disturbed body temp perception; increased blood alkaline phosphatase, increased wt; primary graft dysfunction.

Increased blood levels w/ CYP3A4 inhibitors eg, antifungals (ketoconazole, fluconazole, itraconazole, voriconazole, isavuconazole), erythromycin, HIV PIs (ritonavir, nelfinavir, saquinavir), HCV PIs (telaprevir, boceprevir, combination of ombitasvir & paritaprevir w/ ritonavir used w/ & w/o dasabuvir), letermovir, cobicistat, nilotinib, imatinib; clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone, Chinese herbal remedies containing extracts of Schisandra sphenanthera; grapefruit juice; NSAIDs, oral anticoagulants & antidiabetics. Potentially inhibited metabolism w/ bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl) oleandomycin. Inhibited CYP3A4-mediated metabolism w/ lansoprazole & ciclosporin. Increased systemic exposure w/ prokinetic agents (eg, metoclopramide, cisapride), cimetidine, Mg-Al hydroxide. Decreased blood levels w/ rifampicin, phenytoin, St. John's Wort (Hypericum perforatum). Increased or decreased blood levels w/ high dose prednisolone or methylprednisolone. Decreased conc w/ carbamazepine, metamizole, INH. Prolonged t_½ of ciclosporin. Increased blood level of phenytoin. Reduced clearance of steroid-based contraceptives. Decreased clearance & increased t_½ of phenobarb & antipyrine. Interferes w/ enterohepatic recirculation of mycophenolic acid. Increased nephrotoxic or neurotoxic effects w/ aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir, aciclovir. Enhanced nephrotoxicity w/ amphotericin B, ibuprofen. Increased hyperkalemia w/ K-sparing diuretics eg, amiloride, triamterene, spironolactone. Avoid use of live attenuated vaccines.

Immunosuppressants

L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.

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