Colistin

Cortisporin ® TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

• Therapy with this product should be limited to 10 days (See WARNINGS )
• The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator
• When using the calibrated dropper: For adults, 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily
• For pediatric patients, 4 drops are suggested because of the smaller capacity of the ear canal
• The patient should lie with the affected ear upward and then the drops should be instilled
• This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal
• Repeat, if necessary, for the opposite ear
• If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension
• This wick should be kept moist by adding further solution every 4 hours
• The wick should be replaced at least once every 24 hours

• See DOSAGE AND ADMINISTRATION
• The safety and effectiveness of Cortisporin ® TC Otic in infants below one year of age have not been established
• The efficacy of Cortisporin ® TC Otic
• In pediatric patients one year or older in the treatment of superficial bacterial infections of the external auditory canal and for the treatment of infections of mastoidectomy and fenestration cavities has been demonstrated in a controlled clinical trial

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

• Avoid contaminating the dropper with material from the ear, fingers, or other source
• This caution is necessary if the sterility of the drops is to be preserved
• If sensitization or irritation occurs, discontinue use immediately and contact your physician
• Do not use in the eyes
• If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to avoid loss of potency
• SHAKE WELL BEFORE USING

• This product is contraindicated in those individuals who have shown hypersensitivity to any of its components
• This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus)

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 (See PRECAUTIONS-General ). Patients being treated with eardrops containing neomycin should be under close clinical observation. Cortisporin ® TC Otic 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. …

Neomycin occasionally causes skin sensitization. Ototoxicity (see WARNINGS section) and nephrotoxicity have also been reported. Adverse reactions have occurred with topical use of antibiotic combinations. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. In another study the incidence was found to be approximately 1%. …

Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of Cortisporin ® TC Otic in pregnant women. It is not known whether Cortisporin ® TC Otic can cause fetal harm when administered to a pregnant woman. …

Store at 20° to 25°C (68° to 77°F). Rx only.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.