Dosage Forms
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)
Pharmacology
Mechanism of Action
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.
Use: Labeled Indications
Otic infections: Treatment of superficial bacterial infections of the external auditory canal (otitis externa); treatment of infections of mastoidectomy and fenestration cavities (suspension only)
Contraindications
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)
Dosage and Administration
Dosing: Adult
Note: Duration of use should be limited to 10 days unless otherwise directed by the health care provider.
Otic infections: Otic: Instill 4 drops 3 to 4 times daily; otic suspension is the preferred otic preparation.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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.
Administration
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 (Rosenfeld [AAP 2014]).
Storage
Store at 15°C to 25°C (59°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined.
Otic: Ear sign or symptom (stinging, burning)
Miscellaneous: Drug-induced hypersensitivity (sensitization to kanamycin, paromomycin, streptomycin, and gentamicin)
Warnings/Precautions
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.
Pregnancy
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination. See individual agents.
Patient Education
What is this drug used for?
- It is used to treat ear infections.
Frequently reported side effects of this drug
- Burning or stinging
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Unable to pass urine
- Change in amount of urine passed
- Ear irritation
- Hearing loss
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
