Colistin, neomycin, thonzonium, and hydrocortisone (Otic)

Colistin, neomycin, thonzonium, and hydrocortisone combination is used to treat infections in the ear canal and infections that occur after surgery or behind the ear (fenestration or mastoidectomy). This medicine has two antibiotics and a cortisone-like (steroid) medicine.

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

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and to look for any unwanted effects.

If your symptoms do not improve within 1 week or if they get worse, contact your doctor immediately.

This medicine may cause permanent hearing loss if used for a long time. Do not use it for more than 10 days.

This medicine may cause serious allergic reactions. Contact your doctor immediately if you have trouble breathing or swallowing, a fast heartbeat, itching skin, a rash or redness, swelling of the face, throat, or tongue, or difficulty breathing.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies done on how colistin, neomycin, thonzonium, and hydrocortisone combination affects children younger than 1 year. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of colistin, neomycin, thonzonium, and hydrocortisone combination.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not 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 may change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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
• Aceclofenac
• Acemetacin
• Alcuronium
• Aldesleukin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Atracurium
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Cholera Vaccine, Live
• Choline Salicylate
• Cidofovir
• Ciprofloxacin
• Cisatracurium
• Clonixin
• Cobicistat
• Colistimethate Sodium
• Conivaptan
• Darunavir
• Decamethonium
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Doxacurium
• Droxicam
• Emtricitabine
• Enoxacin
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Fazadinium
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Foscarnet
• Fosnetupitant
• Furosemide
• Gallamine
• Gatifloxacin
• Gemifloxacin
• Hexafluorenium
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Ketorolac
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metocurine
• Mivacurium
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Ofloxacin
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Pancuronium
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pipecuronium
• Piroxicam
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rapacuronium
• Rocuronium
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sorafenib
• Sparfloxacin
• Sulindac
• Tacrolimus
• Tenofovir Alafenamide
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Tubocurarine
• Valdecoxib
• Vecuronium

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both 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
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

• Infection (e.g., herpes simplex virus, varicella zoster virus)—Should not be used in patients with this condition.

• Perforated eardrum (tear or hole)—Use with caution. May worsen side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor right away 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 how often you urinate or the amount of urine
• Crusting, dryness, flaking, or scaling of the skin
• 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
• Thinning of the skin with easy bruising
• Trouble 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 gets used to the medicine. Also, your healthcare professional may be able to tell you how 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:

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 happen 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.

In the U.S.

• Coly-Mycin S
• Cortisporin TC

In Canada

• Coly-Mycin

Available Dosage Forms:

• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Hydrocortisone

Chemical Class: Neomycin

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.

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.