"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
Pediotic Patient Information including How Should I Take
In this Article
- What is hydrocortisone, neomycin, and polymyxin B otic (Pediotic)?
- What are the possible side effects of hydrocortisone, neomycin, and polymyxin B otic?
- What is the most important information I should know about hydrocortisone, neomycin, and polymyxin B otic?
- What should I discuss with my health care provider before using hydrocortisone, neomycin, and polymyxin B otic?
- How should I use hydrocortisone, neomycin, and polymyxin B otic?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using hydrocortisone, neomycin, and polymyxin B otic?
- What other drugs will affect hydrocortisone, neomycin, and polymyxin B otic?
- Where can I get more information?
What should I discuss with my health care provider before using hydrocortisone, neomycin, and polymyxin B otic?
You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:
- a ruptured ear drum; or
- an ear infection caused by chickenpox, or herpes infection (simplex or zoster).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
- herpes (simplex or zoster);
- chickenpox or small pox;
- any ear infection that causes blistering;
- asthma or sulfite allergy; or
- if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Hydrocortisone and colistin can pass into breast milk and may 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 younger than 2 years old.
How should I use hydrocortisone, neomycin, and polymyxin B otic?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Before using this medication, clean and dry your ear canal with sterile cotton.
Shake the ear drops well just before you measure a dose.
This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.
Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.
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. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.
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, stay lying down or with your head tilted for at least 5 minutes.
As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.
Wipe the ear 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 1 week of using this medication.
Store this medication at room temperature away from moisture and heat.
Additional Pediotic Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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