Neomycin, polymyxin b, and hydrocortisone (Otic)

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

Neomycin and polymyxin B are antibiotics. They work by killing bacteria or stopping them from growing. 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 improve within 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, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies to date have not shown any pediatric-specific problems that would limit the effectiveness of neomycin, polymyxin B, and hydrocortisone ear drops in children. Safety and effectiveness have been established.

Geriatric

Studies to date have not shown any geriatric-specific problems that would limit the effectiveness of neomycin, polymyxin B, and hydrocortisone eye 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

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if interactions might happen. In these situations, your doctor may want to adjust the dose, or take other precautions. 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 taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor about 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 necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor right away 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 that were not present before using this medicine

Rare

• Stinging and burning feeling in the middle ear

Incidence not known

• Blood in the urine
• Change in how often you urinate or how much urine you produce
• Difficulty 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 hearing
• Vomiting
• Weakness

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also be able to help you find ways to prevent or reduce some of these side effects. Check with your healthcare 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, talk to your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.