Auralgan

What is Auralgan and how is it used?

Auralgan is a prescription medicine used to treat the symptoms of inflammation of the middle ear (Acute Otitis Media) and to remove earwax (cerumen). Auralgan may be used alone or with other medications.

Auralgan belongs to a class of drugs called Otic Anesthetics.

It is not known if Auralgan is safe and effective in children younger than 2 years of age.

What are the possible side effects of Auralgan?

Auralgan may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• burning, stinging, redness, or new pain in or around the ears,
• bluish skin,
• fast heartbeat,
• headache,
• confusion,
• severe tiredness,
• weakness, and
• severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Auralgan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Each mL contains:

Antipyrine  ............................................ 54.0 mg

Benzocaine ........................................... 14.0 mg

Glycerin dehydrated q.s. to ..................... 1.0 mL

(contains not more than 0.6% moisture)
 (also contains oxyquinoline sulfate)

TOPICAL DECONGESTANT AND ANALGESIC

Auralgan is an otic solution containing antipyrine, benzocaine, and dehydrated glycerin. The solution congeals at 0° C (32° F), but returns to normal consistency, unchanged, at room temperature.

INDICATIONS

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, especially 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

DOSAGE AND ADMINISTRATION

ACUTE OTITIS MEDIA

Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) 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 Auralgan (antipyrine, benzocaine and glycerin dehydrated) and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

REMOVAL OF CERUMEN

Before:  Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
After:   Auralgan (antipyrine, benzocaine and glycerin dehydrated) is useful for drying out the canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Auralgan (antipyrine, benzocaine and glycerin dehydrated) should be inserted into the meatus following instillation.

Note:  Do not rinse dropper after use.

Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.

Protect the solution from light and heat, and do not use if it is brown or contains a precipitate.

DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.

HOW SUPPLIED

Auralgan (antipyrine, benzocaine and glycerin dehydrated) ® Otic Solution, in package containing 10 mL bottle with separate dropper-screw cap attachment (NDC 0046-1000-10).

Store at room temperature (approximately 25° C).

Manufactured by:
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101

SIDE EFFECTS

No Information Provided.

DRUG INTERACTIONS

No Information Provided.

WARNINGS

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term studies in animals or humans have been conducted

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Auralgan (antipyrine, benzocaine and glycerin dehydrated) . It is also not known whether Auralgan (antipyrine, benzocaine and glycerin dehydrated) can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Auralgan (antipyrine, benzocaine and glycerin dehydrated) should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Auralgan (antipyrine, benzocaine and glycerin dehydrated) is administered to a nursing woman.

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

Hypersensitivity to any of the components or substances related to them.

Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

CLINICAL PHARMACOLOGY

Auralgan (antipyrine, benzocaine and glycerin dehydrated) combines the hygroscopic property of dehydrated glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and alleviate pain and discomfort in acute otitis media.

Auralgan (antipyrine, benzocaine and glycerin dehydrated) does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

PATIENT INFORMATION

No Information Provided.