Please note, this OEL/ADE monograph also applies to betahistine hydrochloride (CASRN 15430-48-5), betahistine dihydrochloride (5579-84-0), betahistine mesylate (CAS RN 54856-23-4) and betahistine monomesylate (CAS RN 380416-14-8). Betahistine is indicated for the treatment of Meniere’s disease and other audiovestibular disorders like vertigo and tinnitus. Betahistine is an analogue of histamine and an H1-receptor agonist. Stimulating the H1- receptors in the inner ear causes a vasodilatory effect and increased permeability in the blood vessels, resulting in reduced endolymphatic pressure. Betahistine acts by reducing the asymmetrical functioning of sensory vestibular organs and increasing vestibulocochlear blood flow, decreasing symptoms of vertigo, tinnitus, balance disorders, and hearing loss associated with Meniere’s disease. Betahistine also acts as a histamine H3- receptor antagonist which causes an increased output of histamine, increase in the direct H1-agonist activity, and inhibition of the activity of vestibular nuclei, helping to restore proper balance and decrease in vertigo symptoms.
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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Affygility Solutions’s 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.