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Clozapine

Antipsychotic Agents
CATEGORIES

Antipsychotic Agents, Serotonin Antagonists, GABA Antagonists


ALIASES

Clozapine 2care4, Clozapine Accord, Clozapine Actavis, Clozapine Mylan, Clozapine Orifarm, Clozapine Sandoz, Clozapine Teva, Leponex, Leponex®, Clozaril, Fazaclo, Lanolept, Lapenax, Leponex, Lodux, Lozapin, Luften, Mezapin, Refract, Refraxol, Sensipin, Sequax, Sizopin, Sizopril, Syclop, Syzopin, Tanyl, Uspen, Versacloz, Zapen, Zapenia, Zapine, Ziproc, Zopin


SUBSTANCES

clozapine


ENVIRONMENTAL CONCERN: MODERATE
A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent. [PubChem]

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MODERATE
The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B, T and risk are from Leponex (clozapine) downloaded 2011-04-29. No new environmental information for clozapine is published on Fass.se (2018-09-04). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Below is Hazard and Risk from Fass environmental information for Leponex (downloaded 2011-04-29)


Hazard
Persistence: "3% (aerobic, 28d, 20-24°C,OECD 301B) not readily biodegradable."

Bioaccumulation: "log Kow 4.1 (Avdeef, 2003), log D 3.4 (pH 7, calculated using the Novartis internal Cheminformatics InSilico Profiling Tool, Novartis Institute of Biomedical Research, based on pKa and logP values; pKa1 = 3.52, pKa2 = 7.57)." The company's conclusion is that the substance has the potential to be stored in aquatic organisms.

Acute toxicity: There is data for 3 trophic levels, lowest for fish (Oncorhynchus mykiss) 710 microg/L.

Risk
PPEC/PNEC is based on sales data in Sweden in year 2010. PEC/PNEC = 0.13 which gives the risk low.

Pharmaceutical analyses of water in Stockholm County
Clozapine has previously been found in purified wastewater in Stockholm County (2005–2012). Clozapine has not been analyzed in recent years.

The report Pharmaceutial residues in the Stockholm aquatic environment
The reduction rate for clozapine in wastewater treatment plants in Stockholm County is between 28 and 49 %.

REFERENCES

  1. Stockholms läns landsting. Miljöklassificerade läkemedel 2014–2015. Stockholm; 2014.
  2. Sammanställning av läkemedelsprovtagningar - Bearbetning av regional försäljningsstatistik av läkemedel samt datamaterial från Stockholms läns landstings mätprogram för läkemedelssubstanser i vattenmiljön, 2005-2012. Trossa AB På uppdrag av Stockholms läns landsting. 2014.
  3. Stockholm Vatten. Läkemedelsrester i Stockholms vattenmiljö. 2010. ISBN 978-91-633-6642-0.