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Otic infections: Treatment of superficial bacterial infections of the external auditory canal (otitis externa); treatment of infections of mastoidectomy and fenestration cavities (suspension only)
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)
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.
Refer to adult dosing.
Note: Duration of use should be limited to 10 days unless otherwise directed by the health care provider.
Otic infections: Children ≥2 years and Adolescents: Otic: Instill 3 drops 3 to 4 times daily
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.
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]).
Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Otic:
Cortisporin: Neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per 1 mL (10 mL [DSC]) [contains potassium metabisulfite]
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)
There are no known significant interactions.
Frequency not defined.
Otic: Ear sign or symptom (stinging, burning)
Miscellaneous: Drug-induced hypersensitivity (sensitization to kanamycin, paromomycin, streptomycin, and gentamicin)
Concerns related to adverse effects:
- Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercorticism 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 Cushings 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.
C
Animal reproduction studies have not been conducted with this combination. See 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.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience burning or stinging. Have patient report immediately to prescriber severe ear irritation or hearing loss (HCAHPS).
- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.