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Cerumenex

Cerumenex


Ear Infection Slideshow Pictures

Cerumenex Drug Description

CERUMENEX® EARDROPS
(triethanolamine polypeptide oleate-condensate)

This product contains dry natural rubber

DRUG DESCRIPTION

CERUMENEX Eardrops contain triethanolamine Polypeptide Oleate-Condensate (10%). Inactive Ingredients: Chlorobutanol 0.5%, Propylene Glycol and Water. Triethanolamine Polypeptide Oleate is a hygroscopic-miscible solution with low surface tension and optimal viscosity of 50-90 cps. It also has a slightly acid pH range (5.0-6.0) to approximate the surface of a normal ear canal.

 

What are the possible side effects of triethanolamine polypeptide oleate otic (Cerumenex)?

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

Stop using triethanolamine polypeptide oleate and call your doctor at once if you have any of these serious side effects:

  • severe itching, burning, or irritation of the ear; or
  • itching, crusting, or scaling of the skin around your ear.

Continue using triethanolamine polypeptide oleate and talk with your doctor if...

Read All Potential Side Effects and See Pictures of Cerumenex »

 

What are the precautions when taking triethanolamine polypeptide (Cerumenex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: other ear problems (e.g., ear drainage, infection, pain, rash, swelling, injury, hole/perforation in the eardrum), dizziness, history of skin reactions or allergies.

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

It is not known whether this drug...

 

Cerumenex


Cerumenex Indications & Dosage


INDICATIONS

For removal of impacted cerumen prior to ear examination, otologic therapy and/or audiometry.

DOSAGE AND ADMINISTRATION

  1. Fill ear canal with CERUMENEX (triethanolamine polypeptide) Eardrops with the patient's head tilted at a 45° angle.
  2. Insert cotton plug and allow to remain 15-30 minutes.
  3. then gently flush with lukewarm water, using a soft rubber syringe (avoid excessive pressure). Exposure of skin outside the ear to the drug should be avoided. The procedure may be repeated if the first application fails to clear the impaction.

FOR EXTERNAL USE IN THE EAR ONLY

HOW SUPPLIED

CERUMENEX (triethanolamine polypeptide) Eardrops (triethanolamine polypeptide oleate-condensate) are supplied in 6 mL (NDC 0034-5490-06) and 12 mL (NDC 0034-5490-12) bottles with a cellophane wrapped dropper.

Store at controlled room temperature 15-30°C (59-86°F). Store in a dry place.

The Purdue Frederick Company Stamford, CT 06901-3431. November 13, 2001.

 

Cerumenex


Cerumenex Side Effects & Drug Interactions


SIDE EFFECTS

Clinical Reactions of Possible Allergic Origin

Localized dermatitis reactions were reported in about 1% of 2,700 patients treated, ranging from a very mild erythema and pruritus of the external canal to a severe eczematoid reaction involving the external ear and periauricular tissue, generally with duration of 2-10 days.

Other reactions which have been reported in connection with the use of CERUMENEX (triethanolamine polypeptide) Eardrops include allergic contact dermatitis, skin ulcerations, burning and pain at the application site and skin rash.

DRUG INTERACTIONS

No information provided.

 

Cerumenex


 

Cerumenex Warnings & Precautions


WARNINGS

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

General

It is recommended that the following precautions be observed in prescribing and administration of this agent:

  1. Extreme caution is indicated in patients with demonstrable dermatologic idiosyncrasies or with history of allergic reactions in general.
  2. Exposure of the ear canal to the CERUMENEX (triethanolamine polypeptide) Eardrops should be limited to 15-30 minutes.
  3. When administering CERUMENEX (triethanolamine polypeptide) Eardrops, care must be taken to avoid undue exposure of the skin outside the ear during the instillation and the flushing out of the medication. If the medication comes in contact with the skin, the area should be washed with soap and water. Use of proper technique (see DOSAGE AND ADMINSITRATION) will help avoid such undue exposure.
  4. CERUMENEX (triethanolamine polypeptide) Eardrops should be used only with caution in external otitis.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of CERUMENEX (triethanolamine polypeptide) Eardrops.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not yet been conducted with CERUMENEX (triethanolamine polypeptide) Eardrops. It is also not known whether CERUMENEX (triethanolamine polypeptide) Eardrops can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERUMENEX (triethanolamine polypeptide) Eardrops 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 CERUMENEX (triethanolamine polypeptide) Eardrops are administered to a nursing mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

 

Cerumenex


Cerumenex Overdosage & Contraindications


OVERDOSE

No information provided.

CONTRAINDICATIONS

Perforated tympanic membrane or otitis media is considered a contraindication to the use of this medication in the external ear canal.

A history of hypersensitivity to CERUMENEX (triethanolamine polypeptide) Eardrops or to any of its components is also a contraindication to the use of this medication.

 

Cerumenex

 


 

Cerumenex Clinical Pharmacology


CLINICAL PHARMACOLOGY

CERUMENEX (triethanolamine polypeptide) Eardrops emulsify and disperse excess or impacted earwax. The triethanolamine polypeptide oleate, a surfactant, in a hygroscopic vehicle lyses cerumen to facilitate removal by subsequent water irrigation.

 

Cerumenex

 


Cerumenex Medication Guide


PATIENT INFORMATION

  1. Patients should be cautioned to avoid placing the applicator tip into the ear canal.
  2. Patients should be cautioned to gently flush the ear with lukewarm water.
  3. Patients should be warned to use CERUMENEX (triethanolamine polypeptide) Eardrops in ears only. Surrounding skin should be promptly rinsed of any excess drops.
  4. Patients should be instructed not to leave CERUMENEX (triethanolamine polypeptide) Eardrops in the ear for longer than 30 minutes. A second application may be made, if needed, but more frequent use must be indicated by the physician.
  5. Patients must be instructed not to exceed the time of exposure, nor to use the medication more frequently than directed by the physician.
  6. Patients should be advised to discontinue the use of the medication in case of a possible reaction and to consult their physician promptly.

 

Cerumenex

 


 

Cerumenex 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.

 

TRIETHANOLAMINE POLYPEPTIDE OLEATE - OTIC

 

(try-ETH-a-nol-a-meen pall-ee-PEP-tide OH-lee-ate)

 

COMMON BRAND NAME(S): Cerumenex

 

USES: This medication is also known as trolamine polypeptide oleate. It is used to remove earwax buildup before an ear examination, treatment, or hearing test. This product helps to soften and loosen earwax, making it easier to remove. Too much earwax can block the ear canal and reduce hearing. This medication should not be used regularly to remove earwax or clean the ears.

 

HOW TO USE: This medication is for use only in the ear as directed by your doctor. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person give 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 fill the ear canal with the drops. 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. Insert a soft cotton plug in the ear and leave it in for 15 to 20 minutes. After this time, remove the plug and gently flush the ear with warm water using an ear syringe with a soft rubber bulb.

Do not rinse the dropper. Replace the dropper cap after use.

Avoid getting any of the medication on the skin outside the ear because it can be irritating. If this occurs, wash the area with soap and water.

Avoid getting this medication in your eyes. If this occurs, rinse the eyes thoroughly with water.

Do not keep this medication in the ear for longer than 20 minutes or use it more often than directed.

If the earwax remains, talk to your doctor before re-using. If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Cerumenex


 

 

Cerumenex Consumer (continued)

SIDE EFFECTS: This medication may cause a temporary burning feeling in your ear for 1 to 2 minutes when it is first applied. If this effect persists or worsens, contact your doctor or pharmacist promptly.

A very serious allergic reaction to this drug is rare. However, stop using this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), ear pain, 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.

 

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: other ear problems (e.g., ear drainage, infection, pain, rash, swelling, injury, hole/perforation in the eardrum), dizziness, history of skin reactions or allergies.

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

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

 

Cerumenex

 


 

Cerumenex Consumer (continued)

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

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 can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: Not applicable.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat, light, and moisture. Do not store in the bathroom. Keep all drug products 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 for more details about how to safely discard your product.

 

Cerumenex


Cerumenex Patient Information Including Side Effects

Brand Names: Cerumenex

Generic Name: triethanolamine polypeptide oleate (otic) (Pronunciation: try eth an OH la meen pol ee PEP tyd OH lee ayt)

 

  • What is triethanolamine polypeptide oleate otic (Cerumenex)?
  • What are the possible side effects of triethanolamine polypeptide oleate otic (Cerumenex)?
  • What is the most important information I should know about triethanolamine polypeptide oleate otic (Cerumenex)?
  • What should I discuss with my health care provider before using triethanolamine polypeptide oleate otic (Cerumenex)?
  • How should I use triethanolamine polypeptide oleate otic (Cerumenex)?
  • What happens if I miss a dose (Cerumenex)?
  • What happens if I overdose (Cerumenex)?
  • What should I avoid while taking triethanolamine polypeptide oleate otic (Cerumenex)?
  • What other drugs will affect triethanolamine polypeptide oleate otic (Cerumenex)?
  • Where can I get more information?

 

What is triethanolamine polypeptide oleate otic (Cerumenex)?

Triethanolamine polypeptide oleate is an emulsion that breaks down natural oils.

Triethanolamine polypeptide oleate otic is used in the ear to break down and loosen earwax that has built up inside the ear canal.

Triethanolamine polypeptide oleate otic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of triethanolamine polypeptide oleate otic (Cerumenex)?

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

Stop using triethanolamine polypeptide oleate and call your doctor at once if you have any of these serious side effects:

  • severe itching, burning, or irritation of the ear; or
  • itching, crusting, or scaling of the skin around your ear.

Continue using triethanolamine polypeptide oleate and talk with your doctor if you have mild itching, burning, or ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about triethanolamine polypeptide oleate otic (Cerumenex)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Avoid allowing this medication to get on the outside of your ear. After applying the ear drops, wipe away any excess liquid from the outside of your ear as quickly as possible. After flushing the ear, wash the outside of your ear with soap and water.

Do not leave this medication in your ear for longer than 30 minutes.

Stop using triethanolamine polypeptide oleate and call your doctor at once if you have any of these serious side effects:

  • severe itching, burning, or irritation of the ear; or
  • itching, crusting, or scaling of the skin around your ear.
Related Drug Centers
  • Cerumenex

 

 

Cerumenex


Cerumenex Patient Information including How Should I Take

In this Article

  • What is triethanolamine polypeptide oleate otic (Cerumenex)?
  • What are the possible side effects of triethanolamine polypeptide oleate otic (Cerumenex)?
  • What is the most important information I should know about triethanolamine polypeptide oleate otic (Cerumenex)?
  • What should I discuss with my health care provider before using triethanolamine polypeptide oleate otic (Cerumenex)?
  • How should I use triethanolamine polypeptide oleate otic (Cerumenex)?
  • What happens if I miss a dose (Cerumenex)?
  • What happens if I overdose (Cerumenex)?
  • What should I avoid while taking triethanolamine polypeptide oleate otic (Cerumenex)?
  • What other drugs will affect triethanolamine polypeptide oleate otic (Cerumenex)?
  • Where can I get more information?

What should I discuss with my health care provider before using triethanolamine polypeptide oleate otic (Cerumenex)?

Do not use this medication if you have:

  • a perforated (ruptured) ear drum; or
  • an ear infection.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication in a child without a doctor's advice.

How should I use triethanolamine polypeptide oleate otic (Cerumenex)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medicine.

Triethanolamine polypeptide oleate otic is often used by your doctor just before an ear exam or other procedure.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, use a small piece of cotton to plug the ear and keep the medicine from draining out. Leave this cotton in place for at least 15 minutes. Wipe away the excess liquid from the outside of your ear as quickly as possible.

Do not leave this medication in your ear for longer than 30 minutes.

Remove the cotton from your ear and prepare a bulb syringe by filling it with warm water. Place the tip of the syringe into your ear and gently squeeze (do not squirt) the water into your ear. Lean over a sink with the ear downward so that the water and wax can drain out freely.

After drainage is complete, wash the outside of the ear with soap and water.

You may repeat this ear-flushing procedure if needed.

Store this medicine at room temperature, away from moisture and heat. Do not freeze.

Related Drug Centers
  • Cerumenex

Cerumenex


Cerumenex Patient Information including If I Miss a Dose

In this Article

  • What is triethanolamine polypeptide oleate otic (Cerumenex)?
  • What are the possible side effects of triethanolamine polypeptide oleate otic (Cerumenex)?
  • What is the most important information I should know about triethanolamine polypeptide oleate otic (Cerumenex)?
  • What should I discuss with my health care provider before using triethanolamine polypeptide oleate otic (Cerumenex)?
  • How should I use triethanolamine polypeptide oleate otic (Cerumenex)?
  • What happens if I miss a dose (Cerumenex)?
  • What happens if I overdose (Cerumenex)?
  • What should I avoid while taking triethanolamine polypeptide oleate otic (Cerumenex)?
  • What other drugs will affect triethanolamine polypeptide oleate otic (Cerumenex)?
  • Where can I get more information?

What happens if I miss a dose (Cerumenex)?

Since triethanolamine polypeptide oleate is used as needed, you are unlikely to be on a dosing schedule.

What happens if I overdose (Cerumenex)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of triethanolamine polypeptide oleate otic is not expected to produce life-threatening symptoms.

What should I avoid while taking triethanolamine polypeptide oleate otic (Cerumenex)?

Avoid allowing this medication to get on the outside of your ear. After applying the ear drops, wipe away any excess liquid from the outside of your ear as quickly as possible. After flushing the ear, wash the outside of your ear with soap and water.

While you are using triethanolamine polypeptide oleate otic, do not use other ear drops or ear medications without your doctor's advice.

What other drugs will affect triethanolamine polypeptide oleate otic (Cerumenex)?

There may be other drugs that can affect triethanolamine polypeptide oleate otic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has more information about triethanolamine polypeptide oleate written for health professionals that you may read.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 1.01. Revision date: 7/13/06.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Related Drug Centers
  • Cerumenex
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