Please note, this OEL/ADE monograph also applies to fenoldopam mesylate (CAS RN 67227-57-0). Fenoldopam is a dopaminergic agonist indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when prompt, but rapidly reversible emergency decline of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function, and oral therapy is not possible. Fenoldopam is a benzazepine derivative, fast-acting vasodilator and an agonist for D1-like dopamine receptors. It binds with moderate affinity to α2-adrenoceptors. It has no significant affinity for D2-like receptors, α1 and β-adrenoceptors, 5HT1 and 5HT2 receptors, or muscarinic receptors. Fenoldopam is a racemic mixture with the R-isomer responsible for the biological activity. The R-isomer has approximately 250-fold higher affinity for D1-like receptors than does the S-isomer. In non-clinical studies, fenoldopam had no agonist effect on presynaptic D2-like dopamine receptors, or α or β -adrenoceptors, nor did it affect angiotensinconverting enzyme activity.
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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