Please note, this OEL/ADE monograph also applies to R-baclofen (Arbaclofen CAS RN 69308-37-8) and Arbaclofen HCl (CAS RN 63701-55-3).Baclofen is a muscle relaxant and antispastic with oral therapy indicated for spasticity. The precise mechanism of action of baclofen has not been fully determined. Baclofen exerts its effects as an agonist at presynaptic GABA-B (bicuculline-insensitive) receptors. It acts mainly at the spinal cord level to inhibit the transmission of both monosynaptic and polysynaptic reflexes, possibly by hyperpolarization of primary afferent fiber terminals, resulting in antagonism of the release of putative excitatory transmitters (i.e., glutamic and aspartic acids).
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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