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Zantac®

MiljöinformationReceptstatusFörmånsstatus
GlaxoSmithKline

Injektionsvätska, lösning 25 mg/ml
(Glasampull 2 ml)

Syrahämmande medel - H2-antagonist

Aktiv substans:
ATC-kod: A02BA02
Utbytbarhet: Ej utbytbar
Läkemedel från GlaxoSmithKline omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Ranitidin

Miljörisk: Användning av ranitidin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Ranitidin är potentiellt persistent.
Bioackumulering: Ranitidin 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 = 0.46 μg/L

Where:

A = 3,096.55 kg (total sold amount API in Sweden year 2016, data from Quintiles IMS).

R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9 *106

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

(Reference 1)

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


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Green Algae (Selenastrum caprocornutum):

IC50 96h (growth) > 150,000 μg/L (OECD 201) (Reference 12)

NOEC = 150,000 μg/L


Water flea (Daphnia pulex):

Acute toxicity

EC50 48 h (immobility) = 657,000 μg/L (OECD 202) (Reference 8)

NOEC = 312,000 μg/L


Water flea (Ceriodaphnia dubia):

Chronic toxicity

NOEC 8 days (reproduction) = 32,000 μg/L (USEPA Method 1002) (Reference 15)

NOEC 7 days (reproduction) = 310 μg/L (ISO 22665) (Reference 16)


Rainbow Trout (Oncorhynchus mykiss):

Acute toxicity

EC50 14 days (lethality) > 100,000 μg/L (OECD 204) (Reference 13)

NOEC 14 days = 100,000 μg/L


Freshwater Rotifer, Brachionus calyciflorus:

Acute toxicity

NOEC (reproduction) 48 hrs = 310 µg/L (ISO 20666) (Reference 16)


Other ecotoxicity data:

Microorganisms in activated sludge

EC50 3 hours (Inhibition) > 1,000,000 μg/L (OECD 209) (Reference 7)


PNEC = 310/50 = 6.20 μg/L


PNEC (μg/L) = lowest NOEC/50, where 50 is the assessment factor applied for two long-term NOECs. NOEC for water flea (= 310 ug/L) has been used for this calculation since it is the most sensitive of the two tested species.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.46/6.2 = 0.074, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase “Use of ranitidine has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Ready degradability:

<1% degradation in 28 days (OECD 301B) (Reference 9)


Inherent degradability:

2% degradation (DOC removal) in 28 days (OECD 302B) (Reference 14)

43% degradation (primary biodegradation) in 28 days


Soil degradation

3%-10% degradation in 64 days (OECD 304) (Reference 10)


Abiotic degradation

Hydrolysis:

DT50 (pH 7) > 1 year (TAD 3.09) (Reference 6)


Photolysis:

DT50 (pH 7) = 70 mins (TAD 3.10) (Reference 4)

Note: Evidence that two photo degradants, AH20319 and AH18937, are very toxic to aquatic organisms (Reference 16).


Justification of chosen degradation phrase:

Ranitidine is not readily biodegradable nor inherently biodegradable. The phrase “Ranitidine is potentially persistent” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Dow = -1.09 at pH 7 (TAD 3.02) (Reference 5)


Justification of chosen bioaccumulation phrase:

Since log Dow < 4, the substance has low potential for bioaccumulation.


Excretion (metabolism)

Ranitidine is not extensively metabolised. The fraction of the dose recovered as metabolites is similar after both oral and i.v. dosing; and includes 6% of the dose in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1 to 2% as the furoic acid analogue. Plasma concentrations decline bi-exponentially, with a terminal half-life of 2-3 hours. The major route of elimination is renal. After IV administration of 150 mg 3H-ranitidine, 98% of the dose was recovered, including 5% in faeces and 93% in urine, of which 70% was unchanged parent drug. After oral administration of 150 mg 3H-ranitidine, 96% of the dose was recovered, 26% in faeces and 70% in urine of which 35% was unchanged parent drug. Less than 3% of the dose is excreted in bile. (Reference 2, 3)


PBT/vPvB assessment

Ranitidine does not fulfil the criteria for PBT and/or vBvP.

All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1). Ranitidine does not fulfil the criteria for PBT and/or vBvP based on a log Dow < 4.



Please, also see Safety data sheets onhttp://www.msds-gsk.com/ExtMSDSlist.asp.


References

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

  2. Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics Zantac (Ranitidine) Tablets 150mg. GlaxoSmithKline, March 2014.

  3. Lauritsen K, Larusen LS, & Rask-Madsen J: Clinical pharmacokinetics of drugs used in the treatment of gastrointestinal diseases (part I). Clin Pharm 1990; 19:11-31.

  4. Croudace CP, Stanley RD, Cornish SK. AH19065B: Determination of UV/Visible Adsorption Spectra. Report No. BL4835/B. Brixham Environmental Laboratory, October 1993.

  5. Croudace CP, Stanley RD, Cornish SK. AH19065B: Determination of Octanol-Water Partition Coefficient. Report No. BL4833/B. Brixham Environmental Laboratory, October 1993.

  6. Croudace CP, Stanley RD, Cornish SK. AH19065B: Hydrolysis as a Function of pH. Report No. BL4831/B. Brixham Environmental Laboratory, October 1993.

  7. Croudace CP and DS Morris. AH19065B: Determination of Activated Sludge Respiration Inhibition. Report No. BL4852/B. Brixham Environmental Laboratory, October 1993.

  8. Craig NCD, Croudace CP, Mather JI, Banner AJ. AH19065B: Acute Toxicity to Daphnia magna. Report No. BL4826/B. Brixham Environmental Laboratory, October 1993.

  9. Long KWJ and Roberts GC. AH19065B: Aerobic Biodegradation in Water. Report No. BL4889/B. Brixham Environmental Laboratory, October 1993.

  10. Long KWJ, Roberts GC, Gillings E. AH19065B: Aerobic Biodegradation in Soil. Report No. BL4914/B. Brixham Environmental Laboratory, October 1993.

  11. Croudace CP and Latham M. AH19065B: Determination of Anaerobic Biodegradability. Report No. BL5336/B. Brixham Environmental Laboratory, January 1995.

  12. Croudace C, Smyth DV, Johnson PA. AH19065B: Toxicity to the Green alga Selenastrum capricornutum. Report No. BL5424/B. Brixham Environmental Laboratory, May 1995.

  13. Caunter JE, Croudace CP, Wallace SJ. AH19065B:14 days Acute Toxicty to Rainbow Trout. Report No. BL5480/B. Brixham Environmental Laboratory, July1995.

  14. Shaefer EC and Kendall TZ. Ranitidine hydrochloride: An Evaluation of Inherent Biodegradability Using the Zahn-Wellens/EMPA Test. Report No. 374E-125. Wildlife International Limited, July 2004.

  15. Wetton PM: Ranitidine hydrochloride: Daphnid, Ceriodaphnia Dubia Survival and Reproduction Test. Report No. 1127/0956. Safepharm Laboratories Limited, March 2006.

  16. Isidori M et al. Effects of Ranitidine and its Photoderivatives in the Aquatic Environment. Environmental International, 35 (2009) 821-825.