Inactive ingredients include anhydrous lactose NF DT, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. al. When initiating therapy with voriconazole or posaconazole in patients already receiving Tacrolimus, it is recommended that the Tacrolimus dose be initially reduced to one-third of the original dose and the subsequent Tacrolimus doses be adjusted based on the Tacrolimus whole blood concentrations.Caspofungin is an inducer of CYP3A and decreases whole blood concentrations of Tacrolimus.Verapamil, diltiazem, nifedipine, and nicardipine inhibit CYP3A metabolism of Tacrolimus and may increase Tacrolimus whole blood concentrations. The active control groups were treated with a cyclosporine-based immunosuppressive regimen (CsA/AZA). References. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.The pharmacokinetics of Tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function.

All patients received prophylactic induction therapy consisting of an antilymphocyte antibody preparation, corticosteroids and azathioprine. Another single dose trial in 32 healthy volunteers established the bioequivalence of the 0.5 mg and 1 mg capsules. Insulin dependence was reversible in 15% of these PTDM patients at one year and in 50% at 2 years post-transplant. © 2001-2020 by American Association for Clinical Chemistry The 12 month post-transplant information from this trial is presented below.The most common adverse reactions ( ≥ 30%) observed in Tacrolimus-treated kidney transplant patients are: infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia and anemia.Adverse reactions that occurred in ≥ 15% of kidney transplant patients treated with Tacrolimus in conjunction with azathioprine are presented below:Two trials were conducted for Tacrolimus -based immunosuppression in conjunction with MMF and corticosteroids. The safety and efficacy of Tacrolimus with sirolimus has not been established in kidney transplant Intravenous use reserved for patients who cannot tolerate capsules orally.The initial oral dosage recommendations for adult patients with kidney, liver or heart transplants along with recommendations for whole blood trough concentrations are shown in Table 1. The use of Tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. (2006 July 1, Revised).


In a patient receiving an IV infusion, the first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion.The observed trough concentrations described above pertain to oral administration of Tacrolimus only; while monitoring Tacrolimus concentrations in patients receiving Tacrolimus injection as a continuous IV infusion may have some utility, the observed concentrations will not represent comparable exposures to those estimated by the trough concentrations observed in patients on oral therapy.The recommended starting dose of Tacrolimus injection is 0.03-0.05 mg/kg/day in kidney and liver transplant and 0.01 mg/kg/day in heart transplant given as a continuous IV infusion.
1. Heparin anti-coagulation is not recommended because of the tendency to form clots on storage. Advise patients to contact their physician should they develop vision changes, deliriums, or tremors [see Warnings and Precautions ( Inform patients that Tacrolimus can cause hyperkalemia. Accessed on 6/9/07.

If PRCA is diagnosed, discontinuation of Tacrolimus should be considered Gastrointestinal perforation has been reported in patients treated with Tacrolimus Capsules, USP; all reported cases were considered to be a complication of transplant surgery or accompanied by infection, diverticulum, or malignant neoplasm. Thirty-one patients were randomized to Tacrolimus-based and 25 to cyclosporine-based therapies. Explore More Sites Available online at http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601117.html. It is recommended that Tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids Tacrolimus Capsules should not be used simultaneously with cyclosporine Use with sirolimus is not recommended in liver and heart transplant. McMillin, G. and Hammett-Stabler, C. Chapter 39: Therapeutic Drug Monitoring, Pg 453-463. By comparing your test results with reference values, you and your healthcare provider can see if any of your test results fall outside the range of expected values.

Tacrolimus (Oral Route, Intravenous Route).

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