II. Background

  1. In U.S., FDA forced manufacturers to stop producing Auralgan, Aurodex, A/B Otic...
    1. FDA cited that these agents were unapproved and without evidence of benefit or safety
    2. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm

III. Indications

IV. Adverse Effects: Benzocaine related (in Aurodex)

V. 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)

VI. Dosing

  1. Use 2-4 drops three to four times daily

VII. Reference

  1. (2014) Presc lett 21(6): 36
  2. (2008) Presc Lett 15(5): 26

Images: Related links to external sites (from Bing)

Related Studies (from Trip Database) Open in New Window

Ontology: Auralgan (C0052662)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
MSH C061943
English Auralgan, Auralgan (obsolete), Destin brand of acetic acid, benzocaine, glycerol, phenazone, polycosanol drug combination, auralgan

Ontology: Antipyrine 54 MG/ML / Benzocaine 14 MG/ML Otic Solution [Auralgan] (C0717202)

Concepts Clinical Drug (T200)
English Auralgan, 54 mg-14 mg/ml otic solution, Antipyrine 54 MG/ML / Benzocaine 14 MG/ML Otic Solution [Auralgan], ANTIPYRINE 54 MG / BENZOCAINE 14 MG / GLYCERIN 1 CC AURICULAR (OTIC) SOLUTION [AURALGAN], Auralgan 54mg-14mg/ml Otic Solution, Auralgan, 54 mg-14 mg/mL otic solution, Auralgan, otic solution, Auralgan (obsolete), 54 mg-14 mg/mL otic solution, Auralgan Otic Solution, Auralgan (antipyrine 54 MG/ML / benzocaine 14 MG/ML) Otic Solution, Auralgan (antipyrine 5.4 % / benzocaine 1.4 % ) Otic Solution, Antipyrine/Benzocaine 54 MG/ML-14 MG/ML Otic Solution [AURALGAN]

Ontology: Aurodex (C0718738)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
English Aurodex, aurodex