What is chloroxylenol, hydrocortisone, and pramoxine (otic)?
Chloroxylenol is an antibiotic that fights bacteria.
Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves
to the brain.
Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause
inflammation, redness, and swelling.
The combination of chloroxylenol, hydrocortisone, and pramoxine otic (for the ear) are used to
treat pain, and swelling caused by ear infections.
Chloroxylenol, hydrocortisone, and pramoxine otic may also be used for other purposes not
listed in this medication guide.
What should I discuss with my healthcare provider before taking chloroxylenol, hydrocortisone, and pramoxine (otic)?
You should not use this medication if you are allergic to chloroxylenol, hydrocortisone, or
pramoxine.
Do not use this medication if you have a ruptured (torn) ear drum, or the medication could
leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or
without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your
doctor will use a special scope to see any tear in your ear drum.
Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic
to any drugs, or if you have any type of illness or infection (other than 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 chloroxylenol, hydrocortisone, and pramoxine otic 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.
How should I take chloroxylenol, hydrocortisone, and pramoxine (otic)?
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.
Do not use the medication in your eyes or take it by mouth. Chloroxylenol, hydrocortisone,
and pramoxine otic is for use in the ears only.
For best results, remove any ear wax or other debris before using the ear drops. Ask your
doctor about safe methods of ear wax removal.
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, keep the ear tilted upward for about 5 minutes. You may also be
able to soak a small cotton wick with the medication and leave it in place. Ask your doctor of
pharmacist for instructions on using a cotton wick.
Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.
Use this medication for the full prescribed length of time. Your symptoms may improve before
the infection is completely cleared. Talk with your doctor if your symptoms do not improve after using
this medication.
Store the ear drops at room temperature away from moisture and heat. Keep the bottle
properly capped.
What happens if I miss a dose of chloroxylenol, hydrocortisone, and pramoxine (otic)?
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until
then to use the medicine and skip the missed dose.
Do not
use extra medicine to
make up the missed dose.
Where can I get more information about chloroxylenol, hydrocortisone, and pramoxine (otic)?
Your pharmacist has information about chloroxylenol, hydrocortisone, and pramoxine (otic) written for health professionals that you may read.
What are the possible side effects of chloroxylenol, hydrocortisone, and pramoxine (otic)?
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 this medication and call your doctor at once if you have any of these serious side
effects:
-
ear drainage or discharge;
-
severe burning or itching in your ear; or
-
worsening pain, irritation, or rash.
Less serious side effects are more likely, and you may have none at all.
This is not a complete list of side effects and others may occur. Tell your doctor about any
unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about chloroxylenol, hydrocortisone, and pramoxine (otic)?
Do not use this medication if you have a ruptured (torn) ear drum, or the medication could
leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or
without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your
doctor will use a special scope to see any tear in your ear drum.
Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic
to any drugs, or if you have any type of illness or infection (other than an ear infection).
Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid
getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.
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.
Stop using this medication and call your doctor at once if you have ear drainage or
discharge, severe burning or itching in your ear, or worsening pain, irritation, or rash.
Less serious side effects are more likely, and you may have none at all.
What should I avoid while taking chloroxylenol, hydrocortisone, and pramoxine (otic)?
Do not use other ear drops during treatment with chloroxylenol, hydrocortisone, and
pramoxine otic without first talking to your doctor.
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.
Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid
getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.
What other drugs will affect chloroxylenol, hydrocortisone, and pramoxine (otic)?
It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol,
hydrocortisone, and hydrocortisone otic. But many drugs can interact with each other. Tell your
doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start a new medication without telling your
doctor.
What happens if I have an overdose of chloroxylenol, hydrocortisone, and pramoxine (otic)?
