Aurodex label

Aurodex

Aurodex Recall

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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.

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

antipyrine

      
benzocaine

Aurodex Manufacturers

  • Major Pharmaceuticals
    Aurodex | Major Pharmaceuticals
    No Recall

    Aurodex | 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.