Colistin-Hydrocortisone-Neomycin-Thonzonium Otic

Colistin-Hydrocortisone-Neomycin-Thonzonium Otic is a combination medication used for the treatment of bacterial infection of the external ear canal.

• Colistin-Hydrocortisone-Neomycin-Thonzonium Otic is available under the following different brand names: Coly-Mycin S, Cortisporin-TC Otic

Common side effects of Colistin-Hydrocortisone-Neomycin-Thonzonium Otic include:

• temporary stinging
• burning, or irritation of the ear for a minute or two when applied
• dryness
• acne
• skin discoloration
• skin peeling, and
• rash

Serious side effects of Colistin-Hydrocortisone-Neomycin-Thonzonium Otic include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe burning or other irritation after using the ear drops,
• hearing loss,
• skin rash,
• itching, 
• redness, swelling, dryness, or scaling of the skin
• serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
• severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Colistin-Hydrocortisone-Neomycin-Thonzonium Otic include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Otic suspension

• (3 mg/10 mg/3.3 mg/0.5 mg)/mL

Bacterial Otitis Externa

Adult dosage

• Instill 5 drops into the affected ear thrice or four times daily; not to exceed 10 days of therapy

Pediatric dosage

• Below 1 year: safety and efficacy not established
• Instill 4 drops into the affected ear thrice daily or four times daily; not to exceed 10 days of therapy

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Colistin-Hydrocortisone-Neomycin-Thonzonium Otic has no noted severe interactions with any other drugs.
• Colistin-Hydrocortisone-Neomycin-Thonzonium Otic has no noted serious interactions with any other drugs.
• Colistin-Hydrocortisone-Neomycin-Thonzonium Otic has no noted moderate interactions with any other drugs.
• Colistin-Hydrocortisone-Neomycin-Thonzonium Otic has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Do not use if external auditory canal disorder is suspected or known to be due to cutaneous viral infection (eg, herpes simplex virus, varicella-zoster virus)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Colistin-Hydrocortisone-Neomycin-Thonzonium Otic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Colistin-Hydrocortisone-Neomycin-Thonzonium Otic?”

Cautions

• For otic use only
• Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti; the risk is greater with prolonged use
• Therapy should be limited to 10 consecutive days; patients being treated with eardrops containing neomycin should be under close clinical observation
• Should be used cautiously in any patient with a perforated tympanic membrane
• Neomycin sulfate may cause cutaneous sensitization; a precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known; discontinue promptly if sensitivity or irritation occurs
• When using neomycin-containing products to control secondary infection in chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin
• The manifestation of sensitization to neomycin is usually alow-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal
• Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed; these symptoms regress quickly upon withdrawing the medication; neomycin-containing applications should be avoided for the patient after that
• As with any other antibiotic preparation, prolonged treatment may result in the overgrowth of nonsusceptible organisms and fungi; if the infection is not improved after one week, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed
• Treatment should not be continued for longer than ten days
• Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections
• Not for use in eyes

Pregnancy and Lactation

• There are no adequate and well-controlled studies of this drug in pregnant women; not known whether therapy can cause fetal harm when administered to a pregnant woman
• Administer during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Colistimethate sodium, the methanesulfonate salt of colistin, was not teratogenic in rats or rabbits given intramuscular doses up to 20 mg/kg (equivalent to 9.3 mg/kg of colistin base, approximately 30 times (rats) or 55 times (rabbits) clinical daily dose based on body surface area and assuming 100% absorption from the ear)
• Colistin has not been shown to have any adverse effects on developing embryos or fetuses at doses relevant to the amount that will be delivered ototopically at recommended clinical doses
• Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, significant systemic levels of neomycin would not be anticipated when the drug is used as directed
• Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels; the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals
• Lactation
  • Hydrocortisone and colistin sulfate appears in human milk following oral administration of the drugs; since systemic absorption of these drugs may occur when they are used topically, use caution when the drug is used by a nursing woman