Cort-Biotic (Otic)

Neomycin, polymyxin B, and hydrocortisone combination ear drops are used to treat infections in the ear canal and to help relieve redness, irritation, and discomfort from certain ear issues. It is also used to treat ear infections that can occur after ear surgery (for example, mastoidectomy or fenestration).

Neomycin and polymyxin B are antibiotics that work by killing bacteria or stopping their growth. Hydrocortisone is a steroid that helps reduce redness, itching, and swelling caused by ear infections.

You can get this medicine only with a prescription from your doctor.

If you and your child's symptoms do not get better in 1 week, or if they get worse, contact your doctor.

Do not use this medicine for more than 10 days unless your doctor tells you to.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare 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.

Pediatric

Appropriate studies performed so far have not shown any pediatric-specific problems that would limit the usefulness of neomycin, polymyxin B, and hydrocortisone ear drops in children. Safety and effectiveness have been established.

Geriatric

Appropriate studies performed so far have not shown any geriatric-specific problems that would limit the usefulness of neomycin, polymyxin B, and hydrocortisone ear drops in older adults.

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

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

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 using 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. Your health care professional may also 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, 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 health care professional.

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

In the U.S.

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

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Neomycin

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.