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.

Last updated on RxList: 4/27/2009

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

1. Fill ear canal with CERUMENEX 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

CERUMENEX 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.

Last updated on RxList: 4/27/2009

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 Eardrops include allergic contact dermatitis, skin ulcerations, burning and pain at the application site and skin rash.

No information provided.

Last updated on RxList: 4/27/2009

Discontinue promptly if sensitization or irritation occurs.

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 Eardrops should be limited to 15-30 minutes.
3. When administering CERUMENEX 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 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 Eardrops.

Pregnancy

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

Last updated on RxList: 4/27/2009

No information provided.

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 Eardrops or to any of its components is also a contraindication to the use of this medication.

Last updated on RxList: 4/27/2009

CERUMENEX 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.

Last updated on RxList: 4/27/2009

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 Eardrops in ears only. Surrounding skin should be promptly rinsed of any excess drops.
4. Patients should be instructed not to leave CERUMENEX 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.

Last updated on RxList: 4/27/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

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.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies.

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.

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.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.