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Betoptic

Novartis

Ögondroppar, lösning 5 mg/ml
(Klar, färglös lösning)

Medel mot glaukom

Aktiv substans:
ATC-kod: S01ED02
Utbytbarhet: Ej utbytbar
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Betaxolol

Miljörisk: Risk för miljöpåverkan av betaxolol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att betaxolol är persistent, då data saknas.
Bioackumulering: Betaxolol 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) = 1.5*10-6 * 0.23029 kg * 100

PEC = 0.0000345 μg/L

Where:

A = 0.23029 kg betaxolol hydrochloride (total sold amount API in Sweden year 2018, 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 = 9 *106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae: no data available


Crustacean (Daphnia magna): no data available


Fish: no data available


Other ecotoxicity data: No data available

PNEC derivation:

No PNEC can be calculated since there is no environmental toxicity data available

 

Environmental risk classification (PEC/PNEC ratio)

Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: "Risk of environmental impact of betaxolol cannot be excluded, since no ecotoxicity data are available."


Degradation 

Biotic degradation

Ready degradability: no data available


Justification of chosen degradation phrase:

As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of betaxolol cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

logKow = 0.155 (method unknown) (Alcon Technical Report 012:38560:0289)

Justification of chosen bioaccumulation phrase:

As log Kow < 4, the following statement is used for Betaxolol: ‘Betaxolol has low potential for bioaccumulation.’


Excretion (metabolism)

Betaxolol is completely absorbed after oral administration. Administration with food does not affect the rate or extent of absorption. The primary route of elimination is hepatic metabolism and urinary excretion. About 15% of a dose is excreted in urine as the unchanged drug but the majority is oxidatively metabolised to inactive and weakly active metabolites, including α-hydroxybetaxolol. There are no active metabolites of clinical importance. (Clarke’s Analysis of Drugs and Poisons, 2017)


PBT/vPvB assessment

Based on screening information, betaxolol cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.


References

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

http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

*Alcon Technical Report 012:38560:0289

*Clarke’s Analysis of Drugs and Poisons. Pharmaceutical Press 2017. MedicinesComplete. Royal Pharmaceutical Press.

https://www.medicinescomplete.com/mc/clarke/current/CLK0205.htm?q=betaxolol&t=search&ss=text&tot=26&p=1#_208902