Cerumenex

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...

Read All Potential Precautions of 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 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.
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