Läs upp

Cookies

Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt

Sök apotek med läkemedlet i lager

Sök lagerstatus

Lisinopril STADA®

MiljöinformationReceptstatusFörmånsstatus
STADA Nordic

Tablett 20 mg
(vit, rund, bikonvex med 20 tryckt på ena sidan, krysskåror på båda sidorna, Ø 8,5 mm)

ACE-hämmare

Aktiv substans:
ATC-kod: C09AA03
Läkemedel från STADA Nordic omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för lisinopril (vattenfri) är framtagen av företaget AstraZeneca för Lisinopril AstraZeneca, Zestoretic, Zestril®

Miljörisk: Användning av lisinopril har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Lisinopril är potentiellt persistent.
Bioackumulering: Lisinopril har låg potential att bioackumuleras.


Läs mer

Detaljerad miljöinformation

PEC/PNEC = 0.0067 μg/L /120 μg/L = 0.000056

PEC/PNEC = ≤ 0.1


Environmental Risk Classification


Predicted Environmental Concentration (PEC)


The PEC is based on following data:


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


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (kg/year) = total sold amount API in Sweden year 2015, data from IMS Health.

R (%) = removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default)(Ref 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default)(Ref 1)

(Note: The factor 109 converts the quantity used from kg to μg).


A = 44.76 kg.

R = 0


PEC = 1.5 * 10-6 * 44.76 * (100-0) = 0.0067 µg/L


Metabolism

Lisinopril dihydrate is not metabolised in the body, with virtually 100% excreted via urine as the parent drug (Ref 2).


Ecotoxicity data

Endpoint

Species

Common name

Method

Time

Result

Ref

EyC50 - Based on Biomass

Pseudo­kirchneriella sub­capitata (formerly known as Sele­nastrum capri­cornutum)

Green Alga

OECD 201

72 h

>120 mg/L

3

NOEC - Based on Biomass

120 mg/L

LOEC - Based on Biomass

>120 mg/L

ErC50 - Based on Growth Rate

>120 mg/L

NOEC - Based on Growth Rate

120 mg/L

LOEC - Based on Growth Rate

>120 mg/L

NOEC - Based on Immobil­isation

Daphnia magna

Giant Water Flea

OECD 202

48 h

120 mg/L

4

LOEC - Based on Immobil­isation

>120 mg/L

LC50

Oncorhynchus mykiss

Rainbow Trout

84/449/EEC C1

96 h

>1060 mg/L

5

NOEC - Based on Mortality & Symptoms of Toxicity

>1060 mg/L

Percentage BOD Inhibition

-

-

DOE 1977

5 d

0% @ 60 mg/L

6

Percentage Respiration Inhibition

-

-

Modified OECD 209

4 – 6 min

2.1% @ 100 mg/L

7

Percentage Inhibition of Anaerobic Gas Production

-

-

DoE 1987

15 d

0% @ 529 mg/L

8

NOEC        No Observed Effect Concentration

LOEC         Lowest Observed Effect Concentration

BOD          Biological Oxygen Demand

E/LC50      Effect/Lethal Concentration resulting in 50% effect/mortality


PNEC (Predicted No Effect Concentration)

Short-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. Therefore, the PNEC is based on the acute toxicity (E/LC50) to the giant water flea (Daphnia magna) and the green alga (Pseudokirchneriella subcapitata) studies, the most sensitive species, and an assessment factor of 1000 is applied, in accordance with ECHA guidance (Ref. 9).


PNEC = 120 000/1000 µg/L = 120 µg/L


Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0.0067 μg/L /120 μg/L =0.000056, i.e PEC/PNEC =≤0.1 which justifies the phrase "Use of lisinopril dihydrate has been considered to result in insignificant environmental risk."


In Swedish: "Användning av lisinoprildihydrat har bedömts medföra försumbar risk för miljöpåverkan.”


Environmental Fate Data

Endpoint

Method

Test Substance Concentration

Time

Result

Ref.

Partition Coefficient Octanol Water

Not specified

-

-

LogP = 1.01

10

BOD

DOE 1977

1 mg/L

5 d

0.16 gO2/g

6

BOD

60 mg/L

< 0.01 gO2/g

Percentage Aerobic Biodegradation

OECD 301C

20 mg/L

28 d

0 %

11

Percentage DOC Removal

OJ 88/L133/106-117

10 mg/L as Carbon

18 - 39 d

<20%

BOD         Biological Oxygen Demand

DOC         Dissolved Organic Carbon


Biotic degradation

Lisinopril dihydrate is not readily biodegradable in accordance to the OECD 301C (Ref 11), with 0% biodegradation after 28 days. Based on this information, (considering that no other data is available) the substance has been assigned the risk phrase: ‘Lisinopril dihydrate is potentially persistent.’


In Swedish: “Lisinoprildihydrat är potentiellt persistent” under the heading “Nedbrytning”.


Bioaccumulation

Since Log P <4 the phrase ‘Lisinopril dihydrate has low potential for bioaccumulation’ is assigned.


In Swedish: ”Lisinoprildihydrat har låg potential att bioackumuleras” under the heading “Bioackumulering”.


Physical Chemistry Data

Endpoint

Method

Test Conditions

Result

Reference

Dissociation Constant

Not Specified

25°C

pKa1 = 2.5

pKa2 = 4.0

pKa3 = 6.7

pKa4 = 10.1

10

Solubility Water

Not specified

-

97000 mg/L

10


References

  1. ECHA] European Chemicals Agency. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (version 3.0).

    February 2016.

    http://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf


  2. Zestril 5mg, 10mg and 20mg tablets. Electronic Medicines Compendium, Accessed 19 October 2016


  3. Lisinopril dihydrate: Determination of toxicity to the green alga Pseudokirchneriella subcapitata. Brixham Environmental Laboratory, AstraZenca, UK, Report BR0485. August 2010


  4. Lisinopril dihydrate: Determination of the acute toxicity to Daphnia magna. Brixham Environmental Laboratory, AstraZencam, UK, Report BR0481. August 2011


  5. Lisinopril dihydrate: Determination of acute toxicity to rainbow trout (Salmo gairdneri). Brixham Environmental Laboratory, AstraZenca, UK, Report BL3660. May 1991


  6. Lisinopril dihydrate: Inhibition of 5 day BOD and determination of COD and total carbon. Brixham Environmental Laboratory, AstraZenca, UK, Report 3726. March 1990


  7. Lisinopril dihydrate: Determination of activated sludge respiration inhibition, total carbon (TC) and chemical oxygen demand (COD). Brixham Environmental Laboratory, AstraZenca, UK, Report BL3657. February 1990


  8. BL3659 Lisinopril dihydrate: Determination of anaerobic sludge digestion inhibition. Brixham Environmental Laboratory, AstraZenca, UK, Report BL3659. February 1990


  9. ECHA, European Chemicals Agency. 2008 Guidance on infomration requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm


  10. The Merck Index. An Encyclopaedia of Chemicals, Drugs and Biologicals. 12th Edition. Budavari S. ; O'Neil M.J. ; Smith A. ; Heckelman P.E. ; Kinneary J.F. ; (Editors). Merck 1996


  11. Lisinopril dihydrate: Determination of toxicity and biodegradability by modified OECD test guideline 303a. Brixham Environmental Laboratory, AstraZenca, UK, Report BL3658. February 1991