Please note, this monograph also includes the pediatric ADE. Fluconazole is indicated for susceptible fungal infections including candidia, sporothrix schenckii and coccidioides. Fluconazole is a triazole antifungal agent that inhibits fungal sterol synthesis by interacting with a cytochrome P450 enzyme, lanosterol 14-α-demethylase, necessary to convert lanosterol to ergosterol, which is an essential component of the fungal cell membrane. Aggregation of 14-α-methyl sterols in the fungi is responsible for the fungistatic activity. Inhibition of ergosterol synthesis results in increased cellular permeability causing leakage of cellular components.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Fluconazole, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.