Please note, this OEL/ADE monograph also applies to phenytoin sodium (CAS RN 630-93-3) and phenytoin calcium (CAS RN 17199-74-5). Phenytoin sodium is often administered as its sodium salt and has been widely used as an anticonvulsant in the treatment of epilepsy, to a lesser extent and more recently, in the treatment of certain cardiac arrhythmias. The primary site of action appears to be the motor cortex where the spread of the seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, Phenytoin tends to stabilize the threshold against hyper excitability caused by excessive stimulation or environmental changes capable of reducing the membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures.
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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