Please note, this OEL/ADE monograph also applies to alternate CAS RN 2709-56-0, flupentixol dihydrochloride (CAS RN 2413-38-9; 51529-01-2), and Flupentixol decanoate (CAS RN 30909-51-4; 201213-08-3). Flupentixol decanoate is a typical antipsychotic of the thioxanthene class. Flupentixol is indicated for the maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation or hyperactivity. Flupentixol is a thioxanthene derivative with antipsychotic properties. The exact mechanism of action of flupentixol has not been established. Its effects resemble those of the phenothiazine fluphenazine, in that it belongs among the antipsychotic drugs which are less likely to cause sedation and hypotension but have greater propensity for producing extrapyramidal reactions. Its primary pharmacological action is dopamine blockade. Flupentixol has a high affinity for D1 and D2 receptors.
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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