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Amlodipine

Hazard 6 P 3 B 0 T 3 Risk See below

Information

The T-value in the score for hazard refers to acute toxicity and it is based on previous environmental information in Fass. Environmental information is missing on fass.se ( 2018-10-11 ). It is voluntary for manufacturers to provide information about environmental impact on fass.se. Underlying data for P and B are from assessment report.

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. Such data have not been found.

Fass environmental information

Fass environmental information for Norvasc (amlodipin) (downloaded 2011-04-06).

Hazard

Persistence: The substance is degraded slowly in the environment.

Bioaccumulation: The substance has the potential to be accumulated in aquatic organisms.

Acute toxicity: There is data for 3 trophic levels, lowest algae 100 microg/L.

Risk

The risk to the environment is insignificant.

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.

Amlodipine, recommended in the Wise List, is better from an environmental point of view than felodipine.

References

  1. European Medicines Agency. European public assessment reports (EPAR).
  2. Goodpoint. Jämförande bedömning av miljörisk vid användning av kalciumantagonisterna amlodipin och felodipin. Stockholm: Goodpoint; 2018.

Author: The Pharmaceutical unit of Region Stockholm