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Kestine

Miljöinformation
Receptstatus
Förmånsstatus
Almirall

Filmdragerad tablett 10 mg
(rund, vit med skåra, 7 mm märkt E10)

tablettbild
Delbarhetsinformation

Antihistamin H1-antagonist

Aktiv substans:
ATC-kod: R06AX22
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Almirall omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Ebastin

Miljörisk: Risk för miljöpåverkan av ebastin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att ebastin är persistent, då data saknas.
Bioackumulering: Ebastin har hög potential att bioackumuleras.


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Detaljerad miljöinformation

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A(100-R)

PEC = 0,0296 μg/L


Where:


A = 216,471 kg (total sold amount API in Sweden year 2023, data from IQVIA)

R = 0 % 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 = 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

No data is available.


Environmental risk classification (PEC/PNEC ratio)

It is not possible to calculate the environmental risk classification (PEC/PNEC ratio) due to lack of data.


Summary phrases for the environmental risk:

Risk of environmental impact of ebastine cannot be excluded, since no ecotoxicity data is available.

Degradation

No degradation data is available.


Summary phrases for degradation:

The potential for persistence of ebastine cannot be excluded, due to lack of data.


Bioaccumulation

Partitioning coefficient: 

log Po/w = 4.1 (method and pH unknown)
(Ref. II)


LogP = 6.89 (predicted data, pH unknown (source ALOGPS)),

LogP = 6.96 (predicted data, pH unknown (source Chemaxon))

(Ref. III)


Justification of chosen bioaccumulation phrase:

Since log P > 4, ebastine has high potential for bioaccumulation.


Excretion (metabolism)

Ebastine is rapidly absorbed and converted by first-pass metabolism, mainly via the CYP3A4 system, to the active metabolite carebastine. Carebastine is mainly eliminated in metabolised form.

After an oral dose of ebastine, less than 1 % is excreted in the urine as carebastine. More than 70 % of the dose is excreted in the urine as conjugated metabolites.

Both ebastine and carebastine are highly protein bound, > 97 %.

(Ref. IV)


References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.

  2. ERA - Ebastine 10 mg and 20 mg Film-coated Tablets, 2016.

  3. Drug Bank data for ebastine, retrieved from Drug Bank March 2025.

  4. SmPC text for Kestine, retrieved from MPA March 2025.


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