Amlodipine

Detailed information

Fass environmental information

Fass environmental information for Exforge (amlodipine, valsartan) (downloaded 2021-06-11).

Hazard

Persistence: The DT₅₀ for amlodipine in the total system is < 32 days. Therefore, the phrase “ the substance is degraded in the environment” is thus chosen.

Bioaccumulation: Log D = - 0.056 (NOTOX 490975). Since log D at an environmentally relevant pH is < 4, amlodipine has a low potential for bioaccumulation.

Acute toxicity: There is data for 3 trophic levels, lowest algae NOEC 29 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.08 which gives the risk insignificant.

Assessment report

Assessment report for Exforge HCT (amlodipine besylate/valsartan/hydrochlorothiazide) EMEA/CHMP/410729/2009.

"AML (amlodipine, editorial remark) shows significant chronic toxicity to aquatic species and has potential to inhibit the microbial activity of activated sludge at high concentrations. It is not readily biodegradable and based on its physical-chemical properties and its high susceptibility to oxidative metabolism in higher organisms it is not expected to bio-accumulate. AML was found to be photolabile. The compound shows moderate adsorption to sludge and partitioning into sediments with only 5.3 to 6.0 % of applied radioactivity as parent substance found in sediments after 21 days." CHMP has requested additional data, see assessment report for Exforge HCT. No such data has been found when searching the EMA's website (2021-06-11).

Report Goodpoint 2018

Comparative assessment of environmental risk with the use of calcium antagonists amlodipine and felodipine in Sweden.

Amlodipine is estimated to be much less fat soluble (log P = 2.1) than felodipine (log P = 4.5). Experimental data (methodology partially unclear) suggests a slightly smaller difference (amlodipine log P = 3.04; felodipine 3.8 to 3.86). Although there are some uncertainties about the exact fat solubility of the substances, both chemical data and comparable data indicate that felodipine is more ecotoxic than amlodipine. An exchange of felodipine for amlodipine is therefore recommended from an environmental point of view. It should be noted, however, that the evidence for environmental risk of felodipine is not very high. Amlodipine is recommended in the Wise list.