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Lasix® Retard

Sanofi AB

Depotkapsel, hård 30 mg
(grön/gul, storlek 5,0 mm x 14,0 mm)

Loop-diuretikum och blodtryckssänkande medel med furosemid i retarderad form

Aktiv substans:
ATC-kod: C03CA01
Utbytbarhet: Ej utbytbar
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?




Miljörisk: Användning av furosemid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att furosemid är persistent, då data saknas.
Bioackumulering: Furosemid har låg potential att bioackumuleras.

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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A*(100-R)

PEC = 0.784 µg/L

A = 5224.620 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS)
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)
P = number of inhabitants in Sweden = 10*106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref I)
D = factor of dilution of waste water by surface water flow = 10 (ECHA default) (Ref I)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Desmodesmus subspicatus):
EC50 72 h (growth inhibition) = 322 210 μg/L
NOEC growth rate = 3 130 μg/L

EC50 72 h (biomass) = 45 140 μg/L

NOEC biomass = 3 130 μg/L

(OECD 201) (Ref II)

Crustacean (Daphnia magna):
EC50 48 h (immobilization) = >100 000 μg/L
(OECD 202) (Ref III)

Fish (Leuciscus idus f. melanotus):
LC50 96 h (mortality) = >500 000 µg/L
(Protocol: non-standard. Additional information: static test. 5 test concentrations. 10 fish/test concentration. pH 8, oxygen content 7 mg/l, temperature 20 °C)
(Ref IV)

Other ecotoxicity data:

PNEC = 100 μg/L

The PNEC (μg/L) = lowest EC50/1000, using results from the most sensitive acute toxicity endpoint and an assessment factor of 1000 (short term toxicity endpoints available for three trophic levels), to add a safety margin to the toxicity endpoint. The most sensitive species was Daphnia magna for which the EC50 used was 100 000 μg/L.

Environmental Risk Classification (PEC/PNEC ratio)

PEC/PNEC = 0.784/100 = 0.0078, i.e. PEC/PNEC ≤ 0.1, which justifies the phrase “Use of furosemide has been considered to result in insignificant environmental risk”.


No degradation data is available, hence justifying the degradation phrase: "The potential for persistence of furosemid cannot be excluded, due to lack of data".


Partitioning coefficient

Log Kow = 2.03 at neutral pH (experimentally derived, method unknown) (Ref V)

Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, furosemide has low potential for bioaccumulation.

Excretion (metabolism)

Furosemide and its metabolite (only a small amount is hepatically metabolized to the defurfurylated derivative, 4-chloro-5-sulfamoylanthranilic acid) are rapidly excreted in urine by glomerular filtration and by secretion from the proximal tubule. In patients with normal renal function, approximately 50% of an oral dose and 80% of an IV or IM dose are excreted in urine within 24 hours. The remainder of the drug is eliminated by nonrenal mechanisms including degradation in the liver and excretion of unchanged drug in the feces. The pharmacological activity of the metabolite is not known. (Ref VI) (Ref VII)


  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

  2. Aventis, 2002a, Study report: Furosemide - Growth Inhibition Test with freshwater algae

  3. Aventis, 2002b, Study report: Furosemide – 48h acute toxicity study in Daphnia magna

  4. Hoechst, 1980, Study report: Furosemide – acute toxicity to Leuciscus idus f. melatonus

  5. Source: DrugBank, Human Metabolome Database (HMDB). Sangster J; LOGKOW Databank. Sangster Res. Lab., Montreal Quebec, Canada (1994).

  6. American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2831

  7. Source DrugBank, available as of Sep 12, 2018, at: http://www.drugbank.ca/drugs/DB00695