Pronunciation:

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate, hye-droe-KOR-ti-sone

Brand Names:

• Antibiotic Otic
• Casporyn HC
• Cort-Biotic
• Cortisporin
• Cortomycin
• Oti-Sone
• Pediotic

Dosage Forms:

• Solution
• Suspension

Classifications:

Therapeutic—

Anti-Infective/Anti-Inflammatory Combination

Pharmacologic—

Adrenal Glucocorticoid

Chemical—

Neomycin

Uses of This Medicine:

Neomycin, polymyxin B, and hydrocortisone combination ear drops is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems. It is also used to treat ear infections as a complication after ear surgery (eg, mastoidectomy, fenestration).

Neomycin and polymyxin B belong to the class of medicines known as antibiotics. They work by killing the bacteria or preventing their growth. Hydrocortisone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by ear infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of neomycin, polymyxin B, and hydrocortisone ear drops in the pediatric population. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of neomycin, polymyxin B, and hydrocortisone eye drops in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Any other ear infection or condition—Use with caution. May make these conditions worse.

• Punctured eardrum or
• Chickenpox or
• Herpes simplex or
• Measles—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should be used only in the ear. Do not put it into the eyes or nose, and do not take it by mouth. If this medicine is swallowed by accident or gets into your eyes, call your doctor right away.

You may warm the ear drops to body temperature (37 °C or 98.6 °F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.

To use the ear drops:

• Wash hands thoroughly with soap and water.
• Shake the bottle well before using it.
• Lie down or tilt your head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal.
• Drop the prescribed number of drops into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.)
• Your doctor may insert a gauze or cotton wick inside your ear and may want you to keep the wick moistened with this medicine. Your doctor also may have other directions for you, such as how long you should keep the wick inside your ear or when you should return to your doctor to have the wick replaced. If you have any questions about this, check with your doctor.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic dosage form (ear drops):
  • For ear canal infection:
    • Adults—4 drops into the affected ear 3 or 4 times a day.
    • Children—3 drops into the ear 3 or 4 times a day.
  • For mastoid cavity infection:
    • Adults—4 to 10 drops in the ear every 6 to 8 hours.
    • Children—4 or 5 drops in the ear every 6 to 8 hours.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you and your child's symptoms do not improve within 1 week, or if they become worse, check with your doctor.

Do not use this medicine for more than 10 days unless otherwise directed by your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Itching, skin rash, redness, swelling, or other signs of irritation in or around the ear not present before the use of this medicine

Rare

Stinging and burning feeling in the middle ear

Incidence not known

Blood in the urine

change in the frequency of urination or amount of urine

difficulty in breathing

dizziness

drowsiness

feeling of fullness in the ears

increased thirst

loss of appetite

loss of balance

loss of hearing

nausea

ringing or buzzing in the ears

swelling of the feet or lower legs

trouble in hearing

vomiting

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Cough

difficulty swallowing

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.