Studies on Hospital Pharmaceutical Manufacturing. (VII). The Revision of Package Insert of 1%Methylene Blue Injection on the Basis of Clinical Need.

Abstract

One percentage Methylene Blue (MB) injection prepared in our hospital pharmacy has been used at concentrations of 0.05% and 0.25% for the treatment for methemoglobinemia and septic shock. In order to provide more information on “the package insert” which we have been making since 1996, we performed a pH variation test using a 1% MB injection and a stability test for 0.05% and 0.25% MB injections.The changes in MB absorbance were monitored by the UV spectrometry method. No significant changes in MB absorbance were observed either at room temperature and 40°C at 1000 Lux fluorescent light or in darkness for 48 hours, under 0.05% or 0.25% MB injection conditions. Based on these results, we were able to increase the amount of information regarding the pH variation tests and stability tests on our package insert.