Antipyrine and benzocaine dosage

antipyrine and benzocaine otic

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Pregnancy
  • Reviews
  • More

What is antipyrine and benzocaine otic?

Antipyrine is a pain reliever.

Benzocaine is a local anesthetic (numbing medicine).

Antipyrine and benzocaine otic (for use in the ears) is a combination medicine used to treat pain and swelling caused by ear infections. This medicine does not contain an antibiotic and will not treat an ear infection.

Antipyrine and benzocaine otic is also used to help remove ear wax.

Medicinal use of this product to treat ear infections has not been approved by the FDA. Antipyrine and benzocaine otic should not be used in place of medication prescribed for you by your doctor.

Antipyrine and benzocaine otic may also be used for purposes not listed in this medication guide.

What is the most important information I should know about antipyrine and benzocaine otic?

Medicinal use of this product to treat ear infections has not been approved by the FDA.

You should not use this medicine if you have a hole in your ear drum (ruptured ear drum).

What should I discuss with my healthcare provider before using antipyrine and benzocaine otic?

You should not use this medicine if you are allergic to antipyrine or benzocaine, or if you have a hole in your ear drum (ruptured ear drum).

It is not known whether antipyrine and benzocaine otic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether antipyrine and benzocaine otic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use antipyrine and benzocaine otic?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Antipyrine and benzocaine otic is for use only in your ears. Avoid getting this medicine in your mouth or eyes. If it does get into any of these areas, rinse with water.

Use this medicine only in the affected ear. You may not need to use it in both ears.

Wash your hands before using this medicine.

To use the ear drops for an ear infection:

  • Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

  • Hold the dropper upside down over your ear and drop in enough medicine to fill the ear canal.

  • Stay lying down or with your head tilted and place a small piece of cotton to plug the ear and keep the medicine from draining out.

  • You may use this medicine every 1 to 2 hours as needed to relieve symptoms

To use the ear drops for ear wax removal, use antipyrine and benzocaine otic 3 times per day for up to 3 days. This will help loosen ear wax for removal. Follow your doctor’s instructions about safely removing the wax from your ear.

Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Call your doctor if your symptoms do not improve, or if they get worse while using antipyrine and benzocaine otic.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of antipyrine and benzocaine otic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using this medication?

Do not use the medicine in your eyes. Antipyrine and benzocaine otic is for use only in the ears.

Do not use other ear drops unless your doctor has told you to.

Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance.

Avoid swimming until your ear infection has completely cleared up.

Antipyrine and benzocaine otic side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call you doctor at once if you have:

  • severe irritation after using the ear drops; or

  • ear discomfort you did not have before using this medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Antipyrine and benzocaine otic dosing information

Usual Adult Dose for Otitis Media:

Apply an amount of solution sufficient to fill the affected ear canal. every 1 to 2 hours as needed for pain relief. Moisten a cotton wick with the solution and insert into the meatus. This procedure may be repeated every 1 to 2 hours until pain is relieved.

Usual Adult Dose for Cerumen Removal:

Apply an amount of solution sufficient to fill the affected ear canal 3 times a day for 2 to 3 days prior to cerumen removal
The patient should lie down with the affected ear upward while the drops are instilled. The patient should remain in this position for 30 to 60 seconds to allow the solution to penetrate the ear.
Just prior to and immediately following the cerumen removal procedure, a cotton pledget saturated with the solution may be inserted into the meatus to eliminate discomfort from the procedure and dry the ear canal.

Usual Pediatric Dose for Otitis Media:

Usual Pediatric Dose for Cerumen Removal:

The patient should lie down with the affected ear upward while the drops are instilled. The patient should remain in this position for 30 to 60 seconds to allow the solution to penetrate the ear.
Just prior to and immediately following the cerumen removal procedure, a cotton pledget saturated with the solution may be inserted into the meatus to eliminate discomfort from the procedure and dry the ear canal.

What other drugs will affect antipyrine and benzocaine otic?

It is not likely that other drugs you take orally or inject will have an effect on antipyrine and benzocaine used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02.

Last reviewed: December 08, 2015
Date modified: May 03, 2017

Medical Disclaimer

More about antipyrine / benzocaine otic

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • 4 Reviews
  • Drug class: otic anesthetics
  • FDA Alerts (1)

Consumer resources

  • Antipyrine and benzocaine Otic (Advanced Reading)

Other brands: A/B Otic, Aurodex, Auroto, Dolotic

Professional resources

  • Acella Antipyrine and Benzocaine Otic Solution (FDA)
  • … +1 more

Related treatment guides

  • Ear Wax Impaction
  • Otitis Media

Antipyrine and Benzocaine Ear Drops

Dosage Form: otic solution

Medically reviewed by Drugs.com. Last updated on Jul 22, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Pregnancy
  • Reviews
  • More

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

DESCRIPTION:

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 0°C (32°F), but returns to normal consistency, unchanged, at room temperature.

Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5-one. The active ingredient is represented by the structural formula:

C11H12N2O
Mol. Wt. 188.22

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 ingredient is represented by the structural formula:

C9H11NO2
Mol. Wt. 165.19

It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.

Each mL Contains: ACTIVES: Antipyrine 54 mg (5.4%), Benzocaine 14 mg (1.4%); INACTIVES: Glycerin, Oxyquinoline Sulfate.

CLINICAL PHARMACOLOGY:

Antipyrine and Benzocaine Otic Solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media.

Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

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, 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.

CONTRAINDICATIONS:

The product is contraindicated in any person with hypersensitivity to any of the components or substances related to them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

WARNINGS:

FOR USE IN EARS ONLY- NOT FOR USE IN EYES

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS:

Information for Patients:

Avoid contaminating the dropper with material from the ear, fingers or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No long term studies have been conducted.

Pregnancy:

Category C. Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution. It is also not known whether Antipyrine and Benzocaine Otic Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution 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 Antipyrine and Benzocaine Otic Solution is administered to a nursing woman.

DOSAGE AND ADMINISTRATION:

Acute otitis media: Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

Removal of Cerumen:

Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.

After: Antipyrine and Benzocaine Otic Solution is useful for drying out the ear canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following instillation.

Use of Dropper:

Remove cap from bottle and discard. Remove dropper from package. Place dropper in bottle and use as directed. After use, do not rinse dropper and place dropper in bottle and close tightly.

NOTE: Do not use if solution is brown or contains a precipitate.

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

HOW SUPPLIED:

Antipyrine and Benzocaine Otic Solution USP is supplied in an amber glass bottle with a dropper in the following size:

10 mL – Prod. No. 12409

Storage: Store between 15°-25°C (59°- 77°F). PROTECT FROM LIGHT AND HEAT.

KEEP OUT OF REACH OF CHILDREN.

Revised February 2008

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-561-62

BAUSCH & LOMB

Antipyrine and Benzocaine Otic Solution USP

Rx Only

USE IN EARS ONLY

10 mL With Dropper

ANTIPYRINE AND BENZOCAINE
antipyrine and benzocaine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-561
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIPYRINE (ANTIPYRINE) ANTIPYRINE 54 mg in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
OXYQUINOLINE SULFATE
Packaging
# Item Code Package Description
1 NDC:24208-561-62 1 BOTTLE, DROPPER in 1 CARTON
1 10 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990 05/31/2017

Labeler – Bausch & Lomb Incorporated (196603781)

Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-561)

Bausch & Lomb Incorporated

Medical Disclaimer

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • 4 Reviews
  • Drug class: otic anesthetics
  • FDA Alerts (1)
  • Antipyrine and benzocaine Otic (Advanced Reading)
  • Acella Antipyrine and Benzocaine Otic Solution (FDA)

Other brands: Aurodex, Aurax

  • Ear Wax Impaction
  • Otitis Media

Auralgan

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/21/2016

Auralgan (antipyrine, benzocaine, and dehydrated glycerin) is a combination of an analgesic, a topical anesthetic, and glycerin that helps to soften earwax, used to relieve pain, congestion, and swelling caused by middle ear inflammation (acute otitis media), and it is also used to help remove earwax (cerumen). Many people using Auralgan do not have serious side effects. Rarely, side effects of Auralgan include:

  • burning/stinging/redness/new pain in or around the ears.

Tell your doctor if you have rare but very serious side effects of Auralgan including:

  • bluish skin, or
  • severe tiredness or weakness.

To treat acute otitis media, the dose of Auralgan is to instill the solution into the wall of the ear canal until it is filled. Repeat every one to two hours per doctor’s instructions until pain and congestion are relieved. Auralgan may interact with other ear medications. Tell your doctor all medications and supplements you use. During pregnancy, Auralgan should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Auralgan (antipyrine, benzocaine, and dehydrated glycerin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *