antipyrine and benzocaine otic

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.

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

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

Common side effects include:

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

Possible serious side effects include:

• Allergic reactions
• Methemoglobinemia

• 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.

• There are no drug interactions listed for antipyrine/benzocaine otic solution.

• 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 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.