Brand Name
US Brand Name
Antibiotic Otic
Casporyn HC
Cort-Biotic
Cortisporin
Cortomycin
Oti-Sone
Pediotic
Description
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 caused by surgery or behind the ear (mastoidectomy or 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.
This product is available in the following dosage forms:
- Solution
- Suspension
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Casporyn HC™ ear drops in children and Cortisporin® ear drops in children younger than 2 years of age. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of neomycin, polymyxin B, and hydrocortisone ear drops in the elderly.
Breastfeeding
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.
Drug Interactions
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:
- Infection (eg, herpes simplex virus, varicella zoster virus) or
- Perforated eardrum (tear or hole)—Should not be used in patients with this condition.
Proper Use
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:
- Before applying this medicine, clean the ear canal thoroughly and dry it with a sterile cotton applicator.
- Shake the bottle well before using it.
- Wash your hands before and after using this medicine.
- 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 medicine 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 also 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. Serious damage to the ear and possible loss of hearing may result from using contaminated ear medicines.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. 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—Instill 4 drops into the affected ear 3 or 4 times a day.
- Children 2 years of age and older—Instill 3 drops into the ear 3 or 4 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For ear canal infection:
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that a doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If you and your child's symptoms do not improve within 1 week, or if they become worse, check with your doctor.
This medicine may cause permanent hearing loss (with long-term use). Do not use it for more than 10 days.
This medicine may cause serious allergic reactions. Check with your doctor right away if you have difficulty in breathing or swallowing, fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing.
Side Effects
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:
Incidence not known
- Blistering, burning, itching, peeling, rash, redness, swelling, or other signs of skin irritation
- blood in the urine
- change in the frequency of urination or amount of urine
- chest tightness
- cough
- crusting, dryness, flaking, or scaling of the skin
- difficulty in breathing
- difficulty swallowing
- dizziness
- drowsiness
- fast heartbeat
- feeling of fullness in the ears
- hives, itching, skin rash
- increased thirst
- loss of appetite
- loss of balance
- loss of hearing
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- ringing or buzzing in the ears
- swelling of the feet or lower legs
- thinning of the skin with easy bruising
- trouble in hearing
- unusual tiredness or weakness
- vomiting
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:
Incidence not known
- Acne, pimples
- burning, itching, and pain in hairy areas
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of the treated areas of dark skin
- pus at the root of the hair
- reddish purple lines on the arms, face, legs, trunk, or groin
- redness and scaling around the mouth
- softening of the skin
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.
DRG-20062295
