Tacrolimus suspension formulation

Tacrolimus suspension formulation

Stability of tacrolimus in an extemporaneously compounded oral liquid.

On each study day, all samples were examined for colour and odour, and pH was measured using a pH 211 meter (Hanna Instruments, Montréal, Quebec). Tacrolimus concentration was then assayed by high-performance liquid chromatography with ultraviolet detection (HPLC-UV).

Tacrolimus suspension formulation

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A recent string of errors associated with tacrolimus, an immunosuppressant used primarily to prevent rejection in transplant recipients, prompted ISMP to review the literature and analyze related events reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the ISMP National Medication Errors Reporting Program (ISMP MERP). We found that tacrolimus has been involved in many reported errors during the past decade that have been caused by a wide variety of factors, the most common of which are described below. 

Tacrolimus suspension formulation

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We recommend that our formulations and instructions are followed strictly since any changes may affect the stability of the product. In some of the formulations we have specified a particular brand of medication, again, changing the brand may affect the stability of the suspension. If the listed flavouring agent is not available then the formulation can be made without the flavouring without affecting the stability in any way.

Tacrolimus suspension formulation

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A recent string of errors associated with tacrolimus, an immunosuppressant used primarily to prevent rejection in transplant recipients, prompted ISMP to review the literature and analyze related events reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the ISMP National Medication Errors Reporting Program (MERP). We found that tacrolimus has been involved in many reported errors during the past decade that have been caused by a wide variety of factors, the most common of which are described below.

Tacrolimus suspension formulation

Effects of Storage Temperature and Time on Stability of Serum Tacrolimus and Cyclosporine A Levels in Whole Blood by LC-MS-MS

These drug levels are not analyzed in every hospital laboratory, but rather the samples are transferred to laboratories in other cities. Therefore samples cannot be analyzed immediately. It is known that prolonged storage time and inappropriate temperature may cause incorrect results for many analyses. In this study, we investigated the effect of storage time and temperature on drug concentrations in whole blood samples in order to determine the optimal storage conditions for accurate measurement of these drugs.

Tacrolimus suspension formulation

Decision to award sole supply to Tacrolimus Sandoz

PHARMAC previously consulted on the proposal in December 2012. A revised proposal was developed following consideration of issues raised in this initial consultation and a second consultation letter issued on 30 January 2014. Refer to the link above for more detail and background information.

Tacrolimus suspension formulation

Related CE

This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Modigraf is a granular formulation of tacrolimus, for twice-a-day administration. Modigraf therapy requires careful monitoring by adequately qualified and equipped personnel.

Tacrolimus suspension formulation

Objective Tacrolimus, an immunosuppressant widely used in solid organ transplantation, is available as a prolonged-release capsule for once-daily oral administration. In the immediate postsurgical period, if patients cannot take intact capsules orally, tacrolimus therapy is often initiated as a suspension of the capsule contents, delivered orally or via a nasogastric tube. This study evaluated the relative bioavailability of prolonged-release tacrolimus suspension versus intact capsules in healthy participants.