Trandolapril is indicated for the treatment of congestive heart failure, high blood pressure and left ventricular impairment due to heart attack. Trandolapril is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. It is a prodrug for trandolaprilat, the active metabolite. Trandolaprilat is thought to lower blood pressure by inhibiting ACE activity. ACE catalyzes the conversion of angiotensin I to the potent vasoconstrictor, angiotensin II. Angiotensin II stimulates secretion of aldosterone and inhibits the release of renin through a negative feedback mechanism. When ACE activity is inhibited, angiotensin II formation is reduced and the interruption of the negative feedback mechanism results in increased plasma renin levels. The reduction of angiotensin II formation also decreases aldosterone secretion and vasoconstriction. The decrease in aldosterone secretion produces diuresis, natriuresis, and a slight increase in serum potassium concentrations.
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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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.