Antipyrine and benzocaine ear drops is a medication for the treatment of ear pain caused by otitis media. It combines antipyrine, a pain reliever, benzocaine, a numbing agent to treat ear pain, and hydroxyquinoline sulfate, an antiseptic. It is sold as Auralgan, Aurodex, Auroto, among other brands, and is abbreviated as A/B otic drops.
Contents
Medical uses
A/B otic drops is indicated for ear pain caused by otitis media. It is used every 2–3 hours as needed for pain.
A/B otic drops is also indicated for the removal of excessive or impacted cerumen. To clear cerumen, it is used 3 times a day for 2–3 days.
Ingredients
Each 1 ml of A/B otic drops contains:
Clinical pharmacology
A/B otic drops are effective because antipyrine reduces pain and inflammation and benzocaine numbs the ear.
Reformulation
In 2008, Auralgan was reformulated to include acetic acid and U-polycosanol 410, in addition to antipyrine and benzocaine. Due to this reformulation, pharmacies could no longer substitute the generic antipyrine/benzocaine drops for a prescription written as "Auralgan". The price for the new formulation was roughly $150.00 compared to the generic price of $2.00.
Current Status
In 2015, in accordance with their initiative to remove unapproved prescription drugs from the market, the FDA mandated that companies stop manufacturing this drug or be subject to criminal charges. The FDA has not evaluated this drug for safety, effectiveness or quality and has concerns about inappropriate dosing and contamination during the manufacturing process. The FDA adverse event reporting database does not have any known cases of adverse events where Auralgan is the primary suspect.