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Auralgan

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Auralgan, Benzocaine with Antipyrine, U-polycosanol 410, Aurodex

  • Background
  1. In U.S., FDA forced manufacturers to stop producing Auralgan, Aurodex, A/B Otic...
    1. Original formulation used benzocaine, antipyrine (phenazone, an nsaid) and Glycerine (for drying) and had a long safety record
    2. Manufacturer changed the formulation (substituted polycosanol for Glycerin) and added acetic acid without FDA approval
      1. FDA cited that these agents were unapproved and without evidence of benefit or safety
    3. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm
    4. https://www.entandallergyspecialists.com/ent-and-allergy/fda-rightly-pulls-auralgan-off-market-forcefully/
  • Indications
  1. Otalgia
  • Adverse Effects
  • Benzocaine related (in Aurodex, Auralgan)
  1. Contact Dermatitis
  2. Methemoglobinemia
  • Precautions
  1. Risk of Methemoglobinemia
    1. Not recommended in age under 2 years
    2. Given lack of topical alternatives, age limit Handicaps the Acute Otitis Media Observation protocol
  2. Avoid overuse and stop if topical reaction
    1. Benzocaine (in Aurodex) is a common cause of Contact Dermatitis
  3. Avoid "new" Auralgan containing U-polycosanol 410 (uproven benefit)
    1. Costs $150 instead of old generic version price of $2
    2. Write to allow pharmacist to substitute with Generic Drug (either Aurodex or Benzocaine with Antipyrine)
  • Dosing
  1. Use 2-4 drops three to four times daily
  • Reference
  1. (2014) Presc lett 21(6): 36
  2. (2008) Presc Lett 15(5): 26