Drug Class Description
Macrolide immunosuppressant
Generic Name
Tacrolimus
Drug Description
1 ml concentrate for solution for infusion contains 5 mg of tacrolimus. Excipients: 200 mg of polyoxyethylene hydrogenated castor oil and 638 mg of dehydrated alcohol.
Presentation
Concentrate for solution for infusionThe concentrate is a clear colourless solution.
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
Prograf 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.
General considerations
The recommended initial dosages presented below are intended to act solely as a guideline. Prograf 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.
Prograf 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.
Prograf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The Prograf dose may vary depending upon the immunosuppressive regimen chosen.
Method of administration
The concentrate should be used for intravenous infusion only after it is diluted with suitable carrier media.
The concentration of a solution for infusion should be within the range 0.004 - 0.100 mg/ml. The total volume of infusion during a 24-hour period should be in the range 20 – 500 ml.
The diluted solution should not be given as a bolus.
Duration of dosing
Patients should be converted from intravenous to oral medication as soon as individual circumstances permit. Intravenous therapy should not be continued for more than 7 days.
Dosage recommendations – Liver transplantation
Prophylaxis of transplant rejection - adults
