Auralgan (Antipyrine, Benzocaine and Glycerin Dehydrated)
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Auralgan (Antipyrine, Benzocaine and Glycerin Dehydrated)

Auralgan
(antipyrine, benzocaine, and dehydrated glycerin)

DRUG 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.

What are the precautions when taking antipyrine, benzocaine and glycerin dehydrated (Auralgan)?

Before using this medication, tell your doctor or pharmacist if you are allergic to antipyrine, benzocaine, or other ingredients in this product (e.g., glycerin, zinc acetate); or to other ester-type anesthetics (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hole in the eardrum (perforated tympanic membrane).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery.

During pregnancy, this medication...

Read All Potential Precautions of Auralgan »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

No Information Provided.

Read the Auralgan (antipyrine, benzocaine and glycerin dehydrated) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No Information Provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Auralgan Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ANTIPYRINE/BENZOCAINE - OTIC

(AN-tee-PYE-reen/BEN-zoe-kane)

COMMON BRAND NAME(S): Auralgan, Aurodex, Auroto

USES: This medication is used to relieve pain, congestion, and swelling caused by middle ear inflammation (acute otitis media). This medication is also used to help remove earwax. This product contains 2 main medications. Benzocaine is a topical anesthetic that helps to numb the pain. Antipyrine is an analgesic that helps to decrease the pain and inflammation. This product may also contain glycerin, which helps to soften the earwax, and/or zinc acetate, which helps to protect the skin.

HOW TO USE: Use this medication exactly as directed by your doctor.

An antibiotic medication may sometimes be prescribed along with this medication if you also have an infection.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes to warm it. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 2 minutes, or insert a soft cotton plug if so directed. You may be instructed by your doctor to moisten the cotton plug with this medication. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.

If you are using this medication to help remove earwax, gently rinsing the ear with warm water or using a soft rubber bulb after 2 to 3 days of treatment may help remove any remaining earwax. Consult your doctor or pharmacist about the safe use of an ear bulb.

Do not use in the eye.

Do not use this medication if it is brown or contains particles.

Inform your doctor if your condition persists after a few days of treatment or if it worsens.

Disclaimer

Auralgan Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: burning/stinging/redness/new pain in or around the ears.

Tell your doctor immediately if any of these rare but very serious side effects occur: bluish skin, severe tiredness/weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Auralgan (antipyrine, benzocaine and glycerin dehydrated) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to antipyrine, benzocaine, or other ingredients in this product (e.g., glycerin, zinc acetate); or to other ester-type anesthetics (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hole in the eardrum (perforated tympanic membrane).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Auralgan Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other ear medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another ear problem unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and heat. Keep bottle tightly closed. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised June 2011. Copyright(c) 2011 First Databank, Inc.

Auralgan
(antipyrine, benzocaine, and dehydrated glycerin)

DRUG 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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Auralgan
(antipyrine, benzocaine, and dehydrated glycerin)

DRUG 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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Auralgan
(antipyrine, benzocaine, and dehydrated glycerin)

DRUG 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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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