Version May 2024
Otic infections: Otic: Instill 4 drops 3 to 4 times daily; otic suspension is the preferred otic preparation. Treatment duration is usually 7 days and may be extended to ≤10 days if symptoms are improving but not yet resolved (AAP [Rosenfeld 2014]; manufacturer's labeling).
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.
(For additional information see "Neomycin, polymyxin B, and hydrocortisone (otic): Pediatric drug information")
Otitis externa, acute: Infants, Children, and Adolescents (Limited data in ages <2 years [Bradley 2015]): Otic (solution or suspension):
Without a cotton wick: Instill 3 drops 3 to 4 times daily
With a cotton wick: Insert saturated wick of cotton; keep moist by adding drops every 4 hours; replace wick every 24 hours
Note: Duration of use should be limited to 10 days unless otherwise directed by the health care provider.
There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in 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.
Frequency not defined: Otic: Ear sign or symptom (stinging, burning)
Hypersensitivity to neomycin, polymyxin B, hydrocortisone, or any component of the formulation; herpes simplex, vaccinia, and varicella infections (suspension only); cutaneous viral infection (herpes simplex virus, varicella zoster virus) of the external auditory canal (solution only)
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. Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered.
• 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's 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's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Sulfites: Some formulations may contain sulfites, which may cause allergic-type reactions in susceptible individuals.
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.
The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to HPA axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Otic:
Generic: Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per 1 mL (10 mL)
Suspension, Otic:
Generic: Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per 1 mL (10 mL)
Yes
Solution (Neomycin-Polymyxin-HC Otic)
1% (per mL): $10.07
3.5-10000-1 (per mL): $10.49
Suspension (Neomycin-Polymyxin-HC Otic)
3.5-10000-1 (per mL): $10.07 - $11.82
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. 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 suspension every 4 hours. The wick should be replaced 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: Avoid contaminating the dropper with material from the ear, fingers, or other source. Prior to use, warm by holding bottle in hands, shake otic suspension well before using. Thoroughly cleanse the external auditory canal and dry with a sterile cotton applicator. 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 suspension every 4 hours. The wick should be replaced at least once every 24 hours. Otic preparations should not be used when the integrity of the tympanic membrane is in question (Rosenfeld [AAP] 2014).
Otic infections: Treatment of superficial bacterial infections of the external auditory canal (otitis externa); treatment of infections of mastoidectomy and fenestration cavities (suspension only)
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with this combination. See individual agents.
It is not known if systemic absorption following topical administration results in detectable quantities in human milk. The manufacturer recommends that caution be exercised when administering neomycin/polymyxin B/hydrocortisone to nursing women. Refer to individual agents.
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.
Polymyxin B: Binds to phospholipids, alters permeability, and damages the bacterial cytoplasmic membrane permitting leakage of intracellular constituents.
See individual agents.
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