Please note, this OEL/ADE monograph also applies to mepacrine/quinacrine hydrochloride (CAS RN 69-05-6) and to quinacrine dihydrochloride dihydrate (CAS RN 6151-30-0). Mepacrine, also known as quinacrine, is an acridine derivative used as an anthelmintic indicated for the treatment of giardiasis and cutaneous leishmaniasis and the management of malignant effusions. It was previously used as an antimalarial agent. Mepacrine is no longer used as an antimalarial agent. It has been most recently used in cutaneous lupus erythematosus. The antiparasitic mechanism of action of mepacrine is not known. Mepacrine binds to DNA in vitro by intercalation between adjacent base pairs, inhibiting transcription and translation to RNA. Studies suggest that mepacrine does not localize to the nucleus of Giardia trophozoites and therefore, DNA binding may not be the primary mechanism of its antimicrobial action; the outer membrane may be involved, however. Mepacrine inhibits succinate oxidation and interferes with electron transport. Additionally, by binding to nucleoproteins, it suppresses the lupus erythematous cell factor and acts as a strong inhibitor of cholinesterase.
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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