Drug Description
Adoport 0.5 mg Capsules, hardAdoport 1 mg Capsules, hardAdoport 5 mg Capsules, hard

Presentation
Adoport 0.5 mg Capsules, hardOpaque white and ivory hard gelatin capsules containing white to off- white powder.Adoport 1 mg Capsules, hardOpaque white and light brown hard gelatin capsules containing white to off- white powder.Adoport 5 mg Capsules, hardOpaque white and orange hard gelatin capsules containing white to off- white powder.

Indications
Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

Adult Dosage
Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of side effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist. Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.General considerationsThe recommended initial dosages presented below are intended to act solely as a guideline. Tacrolimus dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.Tacrolimus can be administered intravenously or orally. In general, dosing may commence orally; if necessary, by administering the capsule contents suspended in water, via nasogastric tubing. Tacrolimus is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The tacrolimus dose may vary depending upon the immunosuppressive regimen chosen.Method of administrationIt is recommended that the oral daily dose be administered in two divided doses (e.g. morning and evening). Capsules should be taken immediately following removal from the blister. The capsules should be swallowed with fluid (preferably water).Capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption.Duration of dosingTo suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.Dosage recommendations – Liver transplantationProphylaxis of transplant rejection - adultsOral tacrolimus therapy should commence at 0.10-0.20 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence approximately 12 hours after the completion of surgery.If the