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Ketoconazole

Antifungal Agents
CATEGORIES

Antifungal Agents, 14-alpha Demethylase Inhibitors


ALIASES

Abba, Adenosan, Apo-Ketoconazole, Aquarius, Botaderm, Daktarin, Dandrazol, Dermatin, Eberset, Folicalm, Fundan®, Fungarest, Fungoral®, Ilgem, Keto-Cure, Keto-Tis, Ketoconazole Abamed, Ketoconazole Actavis, Ketokonazole Alternova, Ketoconazole Apotex, Ketoconazole Aristo, Ketoconazole Arrow, Ketoconazole Aurobindo, Ketoconazole Aurovitas, Ketoconazole Biogaran, Ketoconazole Cinfa, Ketoconazole Cristers, Ketokonazole Copyfarm, Ketoconazole DR. MAX, Ketokonazole Euromedicines, Ketokonazole Hasco, Ketoconazole HRA, Ketoconazole J-C, Ketokonazole Korhispana, Ketoconazole MK, Ketoconazole Mylan, Ketokonazole Pharmagenus, Ketokonazole Ratiopharm, Ketokonazole Teva, Ketokonazole VIR, Ketoconazole Zentiva, Keto-Cure, Ketoisdin, Ketonova, Ketopin, Ketoson, Ketopine, Ketozol, Kezol, Kontact, Medic Blue, Mikanisal, Neo-Egmol, Nizax, Nizoral, Noell, Nyoxep, Orifungal M, Oronazol, Panfungol, Sinazol, Spendor, Tedol, Triatop, Xolegel, Zoxin-med


SUBSTANCES

ketoconazole


ENVIRONMENTAL CONCERN: MODERATE
Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients. [PubChem]

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MODERATE
Large margin between concentrations in the environment and the concentration that affects the environment. The primary source is shampoo for dandruff.

Ketoconazole has not been detected in treated wastewater and raw water in Stockholm County in the last five years (2012-2016).

Is recommended in The Wise List. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise List. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.

Information from assessment report for Ketoconazole HRA, 25 September 2014, EMA/CHMP/534845/2014: Ketokonazole is a potential endocrine disruptor.

The risk classification low, according to Fass.se, is based on total sold amount (kg) of the substance in Sweden during the year 2013 and the toxicity of the substance.

REFERENCES

  1. Van De Steene, J. C., C. P. Stove and W. E. Lambert (2010). A field study on 8 pharmaceuticals and 1 pesticide in Belgium: Removal rates in waste water treatment plants and occurrence in surface water. Science of The Total Environment 408 (16): 3448-3453.¨
  2. Wahlberg C, Björnelius B, Paxeus N, Läkemedelsrester i Stockholms Vattenmiljö, Stockholm Vatten, 2015.
  3. UNESCO and HELCOM. 2017. Pharmaceuticals in the aquatic environment of the Baltic Sea region - A status report. UNESCO Emerging Pollutants in Water Series – No. 1, UNESCO Publishing, Paris.
  4. Fent, K., Weston, A., Caminada, D. (2006) Ecotoxicology of human pharmaceuticals, Aquat Toxicol.,Volume 76, Issue 2, 122-159,
  5. Ankley, G. T., Jensen, K. M., Kahl, M. D., Makynen, E. A., Blake, L. S., Greene, K. J., Johnson, R. D. and Villeneuve, D. L. (2007), Ketoconazole in the fathead minnow (Pimephales promelas): Reproductive toxicity and biological compensation. Environ. Toxicol. Chem, 26: 1214-1223
  6. Hegelund, T. , Ottosson, K. , Rådinger, M. , Tomberg, P. and Celander, M. C. (2004), Effects of the antifungal imidazole ketoconazole on CYP1A and CYP3A in rainbow trout and killifish. Environ. Toxicol. Chem., 23: 1326-1334
  7. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  8. SLL. Sammanställning av läkemedelsprovtagningar - Bearbetning av regional försäljningsstatistik av läkemedel samt datamaterial från Stockholms läns landstings mätprogram för läkemedelssubstanser i vattenmiljö, 2012–2016.
  9. IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3, B 2014 Pharmaceuticals.
  10. IVL Swedish Environmental Research Institute Ltd Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E. Screening 2014. Analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. Rapport C 135.
  11. Fick J, Lindberg RH, Tysklind M, Larsson DG. Predicted critical environmental concentrations for 500 pharmaceuticals. Regul Toxicol Pharmacol. 2010;58:516-23.
  12. European Medicines Agency. European public assessment reports (EPAR).