Please note, this OEL/ADE monograph also applies to indapamide hemihydrate (CAS RN 180004-24-4). Indapamide is an oral antihypertensive agent and diuretic, alone or in conjunction with other antihypertensive drugs, to treat edema associated with heart failure and mild to moderate hypertension. Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to the thiazide group of diuretics. It is called a thiazide-like diuretic, but the structure is distinctive enough (lacking the thiazo-ring); therefore, it is not clear that the mechanism is comparable. Indapamide inhibits the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action. Indapamide blocks the slow component of delayed rectifier potassium current (IKs) without altering the rapid component (IKr) or the inward rectifier current. Specifically, it. blocks or antagonizes the action of the proteins KCNQ1 and KCNE1. Indapamide is also thought to stimulate the synthesis of the vasodilatory hypotensive prostaglandin PGE2.
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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