Chemistry:Clobutinol

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Short description: Chemical compound
Clobutinol
Clobutinol.png
Clinical data
Trade namesBiotussin, Lomisat, Pertoxil, Silomat
AHFS/Drugs.comInternational Drug Names
Routes of
administration
oral
ATC code
Legal status
Legal status
  • Withdrawn
(EU)
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC14H22ClNO
Molar mass255.79 g·mol−1
3D model (JSmol)
ChiralityRacemic mixture
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Clobutinol is a cough suppressant formerly distributed by Boehringer Ingelheim and its licensees under the names Lomisat and Silomat, by Bioter as Biotussin, and by Violani-Farmavigor as Pertoxil. It has been withdrawn from the market worldwide.

Side effects and withdrawal

Side effects include drowsiness, dizziness, insomnia, nausea, vomiting, and abdominal discomfort.[1] Studies in 2004 had indicated that clobutinol has the potential to prolong the QT interval.[2] Clobutinol was in 2007 determined to cause cardiac arrhythmia in some patients.[3]

Boehringer Ingelheim products containing clobutinol were voluntarily withdrawn from sale in Germany , and the rest of the world, on August 31, 2007.[4]

The approval for Germany and the EU was revoked in 2008.[5]

Prior to withdrawal, it was available throughout Europe and Central America, as well as in South Africa. Trade names include Biotussin, Lomisat (Spain), Pertoxil (Italy), and in most of the world, Silomat.[6]

See also

References

  1. Drugs Available Abroad, 1st Edition. Derwent Publications Ltd.. 1991. p. 29. ISBN 0-8103-7177-4. 
  2. "A common antitussive drug, clobutinol, precipitates the long QT syndrome 2". Molecular Pharmacology 66 (5): 1093–102. November 2004. doi:10.1124/mol.104.001065. PMID 15280442. 
  3. "Clobutinol-haltige Arzneimittel: BfArM ordnet Widerruf der Zulassung an.". BfArM (German Federal Institute for Drugs and Medical Devices). 2007-08-31. http://www.bfarm.de/DE/BfArM/Presse/mitteil2007/pm20-2007.html. "Clobutinol: BfArM orders cancellation of approval" 
  4. "Boehringer Ingelheim voluntarily withdraws its clobutinol containing medications.". Boehringer Ingelheim. 2007-08-31. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2007/31_august_2007.html. 
  5. "Cancellation of approval" (pdf). BfArM (German Federal Institute for Drugs and Medical Devices). 2008-06-06. http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/globutinol_bescheid_080613.pdf?__blob=publicationFile. "Die Zulassungen für die o.g. Arzneimittel werden mit sofortiger Wirkung widerrufen." 
  6. Drugs Available Abroad, 1st Edition. Derwent Publications Ltd.. 1991. p. 29. ISBN 0-8103-7177-4.