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Author: Admin | 2025-04-28
Can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see WARNINGS AND PRECAUTIONS].HyperkalemiaAdvise patients not to use salt substitutes without consulting their healthcare provider [see DRUG INTERACTIONS].Nonclinical ToxicologyCarcinogenesis, Mutagenesis, Impairment Of FertilityAmlodipineRats and mice treated with amlodipine maleate in the diet for up to 2 years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on mg/m basis, similar to the MRHD of 10 mg amlodipine/day. For the rat, the highest dose was, on a mg/m basis, about 2.5 the MRHD (Calculations based on a 60 kg patient).Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects at either the gene or chromosome level.There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the MRHD of 10 mg/day on a mg/m² basis).ValsartanThere was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at concentrations calculated to provide doses of up to 160 and 200 mg/kg/day, respectively. These doses in mice and rats are about 2.4 and 6 times, respectively, the MRHD of 320 mg/day on a mg/m² basis. (Calculations based on a 60 kg patient.)Mutagenicity assays did not reveal any
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