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Losec®

MiljöinformationReceptstatusFörmånsstatus
AstraZeneca

Enterotablett 10 mg
(ljust rosa, 6,5×12 mm, bikonvexa, filmdragerade tabletter, märkta med LOSEC-symbol på ena sidan och 10 mg på den andra)

Syrahämmande medel - protonpumpshämmare

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ATC-kod: A02BC01
Läkemedel från AstraZeneca omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Omeprazol

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


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Detaljerad miljöinformation

PEC/PNEC = 0.75 µg/L / 41.9 µg/L = 0.018

PEC/PNEC ≤ 0.1


Environmental Risk Classification


Predicted Environmental Concentration (PEC)

The PEC is based on the 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. Data is available to demonstrate rapid hydrolysis,however 0% removal represents worst case.

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 = 4994.31 kg. This figure is based on the sum of the sales figures of all the salt forms; omeprazole (4862.03 kg) + omeprazole magnesium (132.28 kg) from IMS Health for 2015.


R = 0


PEC = 1.5 × 10-6 × 4994.31 × (100-0) = 0.75 µg/L

(Note: Whilst omeprazole is extensively metabolised, little is known about the ecotoxicity of the excreted metabolites. Hence, for the purpose of this calculation, it is assumed that 100% of excreted metabolites have the same ecotoxicity as the parent compounds.)


Metabolism

Almost 80% of an oral dose of omeprazole is excreted as metabolites in the urine, and the remainder is found in the faeces, primarily originating from bile secretion (Ref 2).


Ecotoxicity data - Omeprazole


Endpoint

Species

Common Name

Method

Time

Result

Ref.

EbC50 – Based on Biomass

Note 1

Pseudokirchneriella subcapitata (formerly known as Selenastrum capricornutum)

Green Alga

OECD 201

72 h

30.1 mg/L

Note 2

3

ErC50 – Based on Growth Rate

Note 1

>75.9 mg/L

Note 2

NOEC - Based on Biomass

Note 1

<1.81 mg/L

Note 2

NOEC - Based on Growth Rate

Note 1

1.81 mg/L

Note 2

EC50 - Based on Immobilisation 

Note 1

Daphnia magna

Giant Water Flea

OECD 202

48 h

>100 mg/L

Note 3

4

LC50

Note 1

Danio rerio (formerly known as Brachydanio rerio)

Zebra fish

OECD 203

96 h

41.9 mg/L

Note 2

5

NOEC - Based on Activated Sludge Respiration Inhibition

Note 4

-

-

OECD 209

3 h

100 mg/L

6

EC50 - Based on Activated Sludge Respiration Inhibition

Note 4

>100 mg/L



PNEC (Predicted No Effect Concentration)

Short-term tests of omeprazole have been undertaken for species from three trophic levels, based on internationally accepted guidelines. Therefore, the PNEC is based on the acute toxicity Zebra fish (Danio rerio), the most sensitive species, and an assessment factor of 1000 is applied, in accordance with ECHA guidance (Ref.7).


PNEC = 41900/1000 = 41.9 µg/L


Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0.75 / 41.9 µg/L = 0.018 µg/L, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase “Use of omeprazole has been considered to result in insignificant environmental risk”

In Swedish: ”Användning av omeprazol har bedömts medföra försumbar risk för miljöpåverkan” under the heading ”Miljörisk”.


Environmental Fate Data - Omeprazole

Endpoint

Method

Test Substance Concentration

Time

Result

Ref.

Half-life

Unknown

In aqueous solution

-

T1/2 @ 20 oC:

pH 4 = 15 mins

pH 7 = 30 h

pH 9 = > week

8

T1/2 =10 h @ 37oC, pH 7



Degradation

Omeprazole has been shown to undergo rapid abiotic degradation (Ref. 8) across the environmentally relevant pH range, with an abiotic half-life of <40 days. However, based on the data above (considering no other data is available), the substance has been assigned the risk phrase "Omeprazole is potentially persistent".


In Swedish: ” Omeprazol är potentiellt persistent” under the heading ”Nedbrytning”

Bioaccumulation

Log D = 2.24.

Omeprazole has has no significant bioaccumulation potential, as indicated by the log D. Therefore the statement “Omeprazole has low potential for bioaccumulation” has been assigned.
 

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


Physical Chemistry Data- Omeprazole

Endpoint

Method

Test Substance Conditions

Result

Ref.

Distribution Coefficient Octanol Water 

Note 4

Unknown

-

Log D (experimental) = 2.24

8

Solubility Water 

Note 4

Note 5

22oC

130 mg/L

Dissociation Constant

Note 4

Unknown

-

pKa(1) = 4 (Pyridinium ion)

Dissociation Constant

Note 4

pKa(2) = 8.8 (Benzimidazole ion)

Note 1: Data from studies on omeprazole sodium.

Note 2: Results are expressed as mean measured concentrations.

Note 3: Concentrations were confirmed by analysis, and results expressed as nominal.

Note 4: Data from studies on omeprazole.

Note 5: This study predates current ERA regulatory requirements and may not have been undertaken to standardised test guidelines.


Esomeprazole is the S-enantiomer of the racemate omeprazole. Only short-term (acute) toxicity data are availble for omeprazole. However, a comprehensive environmental data set using more scientifically robust long-term data is available for esomeprazole (these data are available at www.fass.se).


References


  1. [ECHA] European Chemicals Agency. February 2016. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (version 3.0)
    http://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf


  2. Regardh C G, et al. The pharmacokinetics of omeprazole in humans – a study of single intravenous and oral doses. Therapeutic Drug Monitoring 1990; 12: 163 -172.


  3. H 168/68 Na salt: acute Toxicity to Pseudokirchneriella sucapitata. Document No. T3355, Corning Hazelton, Harrogate, England. June 1996.


  4. H 168/68 Na salt: acute Toxicity to Daphnia Magna. Document No. T3353, Corning Hazelton, Harrogate, England. June 1996.


  5. H 168/68 Na salt: acute Toxicity to Brachydanio rerio. Document No. T3354, Corning Hazelton, Harrogate, England. June 1996.


  6. IVL Swedish Environmental Research Institute Commissioned Report; Investigation of the ‘ready biodegradability’ of A001 drug substance, Report BD3984. June 1991.


  7. ECHA, European Chemicals Agency. May 2008. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf


  8. Marketing. S1-03 (pre-CTD) Physicochemical Data, APCD 23075, Omeprazole pwd. August 1985.