Note, this monograph also applies to tizanidine HCl (CAS RN 64461-82-1).Tizanidine is and antispasmodic agent and skeletal muscle relaxant indicated for the management of muscle spasticity associated with multiple sclerosis or with spinal cord injury or disease. Tizanidine reduces spasticity by causing presynaptic inhibition of motor neurons by acting as an agonist at α2-adrenergic receptor sites. The action of tizanidine leads to a reduction in the release of excitatory amino acids like glutamate and aspartate, which cause neuronal firing leading to muscle spasm. The strongest effect of tizanidine has been shown to occur on spinal polysynaptic pathways.
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.