Please note, this OEL/ADE monograph also applies to penciclovir hydrochloride (CAS RN 97845-62-0). Penciclovir is an antiviral topical cream indicated for the treatment of recurrent herpes labialis (cold sores) of the lips and face. Penciclovir is an acyclic guanine nucleoside analog that has demonstrated in vitro inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2), varicella-zoster virus (VZV) and Epstein-Barr virus. Penciclovir is phosphorylated via viral thymidine kinase to a monophosphate form, which is subsequently converted to penciclovir triphosphate by cellular kinases. Intracellular conversion to the triphosphate form is required for antiviral activity. In vitro studies demonstrate that penciclovir triphosphate competitively inhibits HSV polymerase with deoxyguanosine triphosphate. Inhibition of DNA synthesis of virus-infected cells suppresses viral replication. In cells not infected with HSV, DNA synthesis is unaltered due to phosphorylation occurring in only within herpes infected cells. Penciclovir is the active metabolite of the oral product famciclovir.
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:
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