antipyrine and benzocaine otic (Auralgan, Aurodex - removed from market)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Tips for Treating Ear Infections

What is antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

Antipyrine/benzocaine is a combination product used for cleaning the ear canal and for treating middle ear infections. It reduces pressure, congestion, inflammation, pain, and discomfort in the ear.

What brand names are available for antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

On July, 2, 2015 the FDA asked all manufacturers of antipyrine and benzocaine otic products (Auralgan and Aurodex brand names) to stop selling these products because they have not been proven to be safe and effective.

Quick GuideTinnitus: Why Are My Ears Ringing?

Tinnitus: Why Are My Ears Ringing?

Is antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued) available as a generic drug?

Yes

Do I need a prescription for antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

Yes

What are the uses for antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

  • Octic antipyrine and benzocaine is used for cleaning earwax (cerumen) and for treating middle ear infections (otitis media).

What are the side effects of antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

Common side effects include:

  • Stinging in the ear
  • Burning in the ear
  • Redness around the ear

Possible serious side effects include:

Quick GuideTinnitus: Why Are My Ears Ringing?

Tinnitus: Why Are My Ears Ringing?

What is the dosage for antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

  • To clean earwax, 3 to 4 drops of antipyrine and benzocaine octic solution is placed into the ear canal three times a day for 2 to 3 days.
  • To treat otitis media the ear canal should be filled with antipyrine/benzocaine solution, and then moistened cotton pledget with solution should be inserted into the ear canal. This may be repeated every one to two hours until there is relief from pain and congestion.

Which drugs or supplements interact with antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

Is antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued) safe to use during pregnancy or while breastfeeding?

  • The use of antipyrine/benzocaine by pregnant women has not been adequately evaluated.
  • It is not known if antipyrine/benzocaine is secreted in breast milk.

What else should I know about antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

What preparations of antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued) are available?
  • Otic solution (antipyrine/benzocaine): 14 /54 mg per mL
How should I keep antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued) stored?
  • Antipyrine/benzocaine solution should be stored at room temperature, between 15 C and 30 C (59 F and 86 F).
How does antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued) work?
  • Antipyrine has pain relieving effects while benzocaine is a local anesthetic (numbing agent). Local anesthetics are chemicals that interfere with the function of the nerves that sense pain.
  • The FDA has not approved products containing antipyrine/benzocaine. On July, 2, 2015 the FDA asked all manufacturers of antipyrine/benzocaine otic products to stop selling these products because they have not been proven to be safe and effective.

REFERENCE: FDA Prescribing Information

Quick GuideTinnitus: Why Are My Ears Ringing?

Tinnitus: Why Are My Ears Ringing?

Summary

Antipyrine and benzocaine otic (Auralgan, Aurodex) was a prescription eye medication used to treat middle ear infections. The FDA asked all manufacturers of antipyrine/benzocaine otic products to stop selling these products because they have not been proven to be safe and effective.) Side effects, drug interactions, warnings, dosing, and breastfeeding information should be reviewed prior to using any medication.

Side effects, drug interactions, warnings, dosing, and breastfeeding information is provided.

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Reviewed on 4/13/2016
References
REFERENCE: FDA Prescribing Information

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