Please note, this OEL/ADE monograph also applies to ranolazine hydrochloride (CAS RN 95635-56-6). Ranolazine is indicated for treatment of chronic angina. Ranolazine is a piperazine derivative and the mechanism of action of its anti-anginal and anti-ischemic effect is unknown. The anti-anginal and anti-ischemic action of ranolazine is not dependent upon heart rate or blood pressure reduction and does not increase myocardial workload. At therapeutic levels, ranolazine can inhibit the inactivating component of the sodium current, although its relationship to angina symptoms is unknown. It also inhibits the rapid inward rectifying current, thereby prolonging the ventricular action potential. Ranolazine acts by inhibiting sodium and potassium ion channel currents which increased myocardial function. It also inhibits delayed rectifier potassium currents, which prolongs the ventricular action potential duration. In some animal models, ranolazine has shown to have antagonistic activity toward the alpha 1- and beta 1- adrenergic receptors and an inhibitory profile against fatty acid oxidation.
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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