Please note, this OEL/ADE monograph also applies to trimipramine (CAS RN 739-71-9). Trimipramine maleate is indicated for the symptomatic relief of depression and treatment of depression accompanied by anxiety, agitation or sleep disturbance. Trimipramine maleate is a tricyclic antidepressant. The mode of action of trimipramine maleate capsules on the central nervous system is not known. It is reported to differ from other tricyclic antidepressants and amphetamine-type compounds, as it does not act primarily by stimulation of the central nervous system. Trimipramine does not inhibit neuronal transmitter uptake, and does not cause down-regulation of beta-adrenoceptors. Also, it was found that trimipramine did not antagonize the inhibitory effect of noradrenaline and 5-hydroxytryptamine release, and it does not act by inhibition of the monoamine oxidase system.
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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