Version May 2024
Otic infections: Otic: Instill 5 drops in affected ear(s) 3 or 4 times daily. Treatment duration is usually 7 days and may be extended to ≤10 days if symptoms are improving but not yet resolved (Ref). Note: Use calibrated dropper provided in packaging.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
Otic infections: Children ≥1 year and Adolescents: Otic: Instill 4 drops in affected ear(s) 3 or 4 times daily
Note: Duration of use should be limited to 10 days. Use calibrated dropper provided in packaging.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Adverse effects are reported for the individual agents rather than for the combination product.
Postmarketing:
Hypersensitivity: Local hypersensitivity reaction
Otic: Ototoxicity
Renal: Nephrotoxicity
Hypersensitivity to neomycin, colistin, hydrocortisone, thonzonium, or any component of the formulation; cutaneous viral infection (eg, herpes simplex virus, varicella zoster virus) of the external auditory canal
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2012).
• Neomycin sensitization: Neomycin may cause cutaneous sensitization (primarily skin rash). Symptoms of neomycin sensitization include itching, low-grade reddening with swelling, dry scaling, itching, and failure to heal. Discontinue immediately if sensitization or irritation occurs.
• Ototoxicity: Neomycin may cause permanent sensorineural hearing loss due to cochlear damage. Risk of ototoxicity is increased in patients with extended use; limit therapy to 10 days. Do not use in any patient with a perforated tympanic membrane.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
• Appropriate use: For otic use only; do not use in the eyes. If infection is not improved after 1 week, preform cultures and susceptibility tests. Avoid contaminating the bottle tip with material from the ear, fingers, or other source.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, otic [drops]:
Coly-Mycin S: Neomycin 0.33%, colistin 0.3%, hydrocortisone acetate 1%, and thonzonium bromide 0.05% (10 mL [DSC]) [contains thimerosal]
Cortisporin-TC: Neomycin 0.33%, colistin 0.3%, hydrocortisone acetate 1%, and thonzonium bromide 0.05% (10 mL) [contains thimerosal]
No
Suspension (Cortisporin-TC Otic)
3.3-3-10-0.5 mg/mL (per mL): $27.80
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For otic use only. Shake otic suspension well before using. Thoroughly cleanse external auditory canal and dry with a sterile cotton applicator. Patient should lie down with affected ear upward and medication instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops. Repeat, if necessary, for the opposite ear. Alternatively, a cotton wick may be inserted into the canal and the cotton may be saturated with the suspension; keep wick moist by adding suspension every 4 hours. Replace wick at least once every 24 hours. Otic preparations should not be used when the integrity of the tympanic membrane is in question (AAP [Rosenfeld 2014]).
Otic: For otic use only. Shake otic suspension well prior to use. Thoroughly cleanse external auditory canal and dry with a sterile cotton applicator. Patient should lie down with affected ear upward and medication instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops. Repeat, if necessary, for the opposite ear. Alternatively, a cotton wick may be inserted into the canal and the cotton may be saturated with the suspension; keep wick moist by adding suspension every 4 hours. Replace wick at least once every 24 hours. Otic preparations should not be used when the integrity of the tympanic membrane is in question (AAP [Rosenfeld 2014]). Avoid contaminating the dropper with material from ear, finger, or other surfaces. Discontinue use if irritation or sensitization occurs.
Otic infections: Treatment of superficial bacterial infections of the external auditory canal (otitis media); treatment of infections of mastoidectomy and fenestration cavities
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with this combination. Refer to the individual Neomycin and Hydrocortisone monographs for additional information.
It is not known if systemic absorption following topical administration results in detectable quantities in human milk. Because hydrocortisone and colistin are excreted into breast milk following oral administration, the manufacturer recommends that caution be exercised when administering to breast-feeding women. Refer to the individual Neomycin and Hydrocortisone monographs for additional information.
Neomycin sensitization (eg, low-grade reddening with swelling, dry scaling, itching, failure to heal)
Colistin: Penetrates and disrupts bacterial cell membrane.
Hydrocortisone: Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.
Neomycin: Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits.
Thonzonium: Promotes tissue contact by dispersion and penetration of the cellular debris and exudate.
See individual agents.
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