Bethanechol oral therapy is indicated for urinary retention. Bethanechol chloride is a cholinergic agent that acts by stimulating the release of acetylcholine at the nerve ending, thereby activating the parasympathetic nervous system. It significantly increases the tone of the detrusor urinae muscle, usually producing a contraction that can sufficiently initiate micturition and bladder emptying. It also modulates gastric motility, increases gastric tone and restores impaired rhythmic peristalsis.
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), 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.