FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Aurodex Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Warnings: FOR USE IN EARS ONLY NOT FOR USE IN EYES
KEEP OUT OF REACH OF CHILDREN
Discontinue promptly if sensitization or irritation occurs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Indications and Usage: Acute Otitis Media of Various Etiologies
Prompt relief of pain and reduction of inflammation in the congestive and serous stages.
Adjuvant therapy during systemic antibiotic administration for resolution of the infection.
Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, epecially in children in whom the tube is shorter, wider and more horizontal than in adults.
Removal of Cerumen
Facilitates the removal of excessive or impacted cerumen
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Each mL contains:
Antipyrine..........54 mg (5.4%)
Benzocaine..........14.0 mg (1.4%)
(also contains glycerin and oxyquinoline sulfate)
AurodexTM Antipyrine and Benzocaine Otic Solution is an otic solution containing antipyrine, benzocaine, oxyquinoline sulfate and anhydrous glycerin for use in the ear. The solution congeals at 0oC (32 oF) but returns to normal consistency, unchanged at room temperature.
Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phyl-3-pyrazolin-5-one. Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol.
Benzocaine is a local anesthetic. it is chemically ethyl-p-aminobenzoate or Benzoic Acid, 4-amino, ethyl ester. The active ingredients are represented by the following structural formula
Sources
Aurodex Manufacturers
-
Major Pharmaceuticals
Aurodex | Major Pharmaceuticals
DOSAGE AND ADMINISTRATION: ACUTE OTITIS MEDIA: Instill AurodexTM Antipyrine and Benzocaine Otic Soution permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with AurodexTM Antipyrine Benzocaine Otic Solution and insert into the meatus. Repeat every one to two hours until pain an congestion are relieved.
REMOVAL OF CERUMEN: Before: Instill AurodexTM Antipyrine and Benzocaine Otic Solution three times daily for two to three days to help detach cerumen from wall of canal and facilitate removal.
After: AurodexTM Antipyrine and Benzocaine Otic Solution is useful for drying out the canal or relieving discomfort.
Before and after removal of cerumen, a cotten pledget moistened with AurodexTMAntipyrine and Benzocaine Otic Solution should be inserted into the meatus following installation.
Note: After use, do not rinse dropper tip, replace cap and close tightly
Protect solution from light and heat, and do not use if it is brown or contains a precipitate.
DISCARD THIS PRODUCT 6 MONTHS AFTER OPENING.
Login To Your Free Account