Description
Colistin, neomycin, thonzonium, and hydrocortisone combination is used to treat infections of the ear canal and infections caused by surgery or behind the ear (fenestration or mastoidectomy). This medicine contains two antibiotics and a cortisone-like (steroid) medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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 have not been performed on the relationship of age to the effects of colistin, neomycin, thonzonium, and hydrocortisone combination in children younger than 1 year of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of colistin, neomycin, thonzonium, and hydrocortisone combination in the elderly.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
- Mifepristone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Alcuronium
- Aldesleukin
- Apalutamide
- Aspirin
- Atazanavir
- Atracurium
- Avacopan
- Balofloxacin
- Bemiparin
- Besifloxacin
- Bupropion
- Carbamazepine
- Cholera Vaccine, Live
- Cidofovir
- Ciprofloxacin
- Cisatracurium
- Clarithromycin
- Cobicistat
- Colistimethate Sodium
- Conivaptan
- Cosyntropin
- Darunavir
- Decamethonium
- Desogestrel
- Dienogest
- Doxacurium
- Drospirenone
- Emtricitabine
- Enoxacin
- Estradiol
- Ethacrynic Acid
- Ethinyl Estradiol
- Ethynodiol
- Fazadinium
- Fedratinib
- Fexinidazole
- Fleroxacin
- Flumequine
- Foscarnet
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alcuronium
- Atracurium
- Auranofin
- Bumetanide
- Colestipol
- Gallamine
- Hexafluorenium
- Licorice
- Metocurine
- Rifapentine
- Rotavirus Vaccine, Live
- Saiboku-To
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)—Should not be used in patients with this condition.
- Perforated eardrum (tear or hole)—Use with caution. May cause side effects to become worse.
Proper Use
Use this medicine only 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.
This medicine is for use only in your ears. Do not get any of it into your eyes, nose, or mouth. Rinse it off right away if it does get on these areas.
To use the ear drops:
- Before applying this medicine, clean the ear canal thoroughly and dry it with a sterile cotton applicator.
- You may warm the ear drops to body temperature by holding the bottle in your hand for a few minutes. If it gets too warm, the medicine may not work properly.
- Shake the bottle well before using it.
- Wash your hands before and after using this medicine.
- Lie down or tilt the 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 cotton wick into your ear soaked with the medicine. Keep it moist by adding more medicine every 4 hours. Replace the cotton wick at least once every 24 hours.
- 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 (ear drops) dosage form (suspension):
- For infections of the ear canal:
- Adults—Instill 5 drops into the ear 3 or 4 times a day.
- Children 1 year of age and older—Instill 4 drops into the ear 3 or 4 times a day.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For infections of the ear canal:
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 your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If your symptoms do not improve within 1 week or if they become worse, check with your doctor right away.
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
- bloody urine
- burning and itching of the skin with pinhead-sized red blisters
- change in the frequency of urination or amount of urine
- crusting, dryness, flaking, or scaling of the skin
- 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
- thinning of the skin with easy bruising
- 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:
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-20061733
