Abstract
Arbekacin (ABK) was approved and widely used in Japan for treatment of patients infected with MRSA, and TDM was introduced in clinical practice. The Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring decided to develop a clinical practice guidelines for TDM of ABK for the following reasons. First, although the daily dose of 150e200 mg was approved in Japan, recent PK- PD studies revealed that higher serum concentration is required to achieve better clinical efficacy and several findings concerning the usefulness of higher dosage regimen have obtained recently. Second, although maximal concentrations that obtained immediately after the end of administration (Cmax )w as generally adopted, the serum concentration at 1 h after initiation of administration (peak serum con- centration (Cpeak)) proved to be more suitable as an efficacy indicator of aminoglycosides. Lastly, as ABK is approved only in Japan, no international practice guideline for TDM has not been available in ABK to date. This guideline evaluated the scientific data associated with serum ABK monitoring and provided rec- ommendations based on the available evidence. Potential limitations of this guideline, however, include the findings that few prospective clinical trials of TDM of ABK are available in the treatment of MRSA infections and that most of the published literature describes observational studies.
Highlights
Voriconazole (VRCZ) is a triazole antifungal developed for the treatment of fungal infectious disease and is available for both oral and intravenous administration
(e) TDM is considered in patients undergoing hematopoietic stem cell transplantation (HSCT) who are being treated with VRCZ as prophylaxis for deepseated mycosis (C1-III)
Trifilio et al [24] conducted a retrospective study of VRCZ concentrations in recipients who had undergone allogeneic HSCT and received VRCZ for the prophylaxis of invasive fungal infection
Summary
Voriconazole (VRCZ) is a triazole antifungal developed for the treatment of fungal infectious disease and is available for both oral and intravenous administration. VRCZ has a nonlinear pharmacokinetic profile with wide inter- and intraindividual variability [2] This variability is caused by many factors, such as sex, age, race, genotypic variation, liver dysfunction, and the presence of food. Another important factor influencing the VRCZ pharmacokinetic profile is drug–drug interactions with CYP450 inhibitors as well as inducers. Mikamo Department of Infection Control and Prevention, Aichi Medical University Graduate School of Medicine, Aichi, Japan. M. Kimura Department of Pharmacy, Aichi Medical University Hospital, Aichi, Japan. M. Seki Division of Infection Control and Prevention, Osaka University Medical Hospital, Osaka, Japan. S. Takakura Department of Infection Control and Prevention, Kyoto University Hospital, Kyoto, Japan. We outline ways in which the existing problems can be solved
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