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Fixed-dose combination

Hydrocortisone, Neomycin and Polymyxin b

Also known as hydrocortisone, neomycin sulfate, polymyxin b sulfate
Available on request
Presentations
9
Brands
1
Manufacturers
4
Available from stock
0

Hydrocortisone, Neomycin and Polymyxin b is a fixed-dose combination of an aminoglycoside antibacterial, a corticosteroid and a polymyxin-class antibacterial. It is available as otic suspension, ear drops and otic solution for ophthalmic use. MedsAcross supplies Hydrocortisone, Neomycin and Polymyxin b for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Aminoglycoside Antibacterial, Corticosteroid, Polymyxin-class Antibacterial, Corticosteroid Hormone Receptor Agonists
US FDA first approval
16 April 1963
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Otic, Ophthalmic
Dosage forms
Otic suspension, Ear drops, Otic solution, Ophthalmic suspension
Fixed-dose combination of
Hydrocortisone, Neomycin, Polymyxin b

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

Dosing overview

Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For children, 3 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 suspension every 4 hours. The wick should be replaced at least once every 24 hours. SHAKE WELL BEFORE USING.

Source: US FDA prescribing information

Contraindications

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

Source: US FDA prescribing information

Warnings and precautions

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. Patients being treated with eardrops containing neomycin should be under close clinical observation. Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension should not be used in any patient with a perforated tympanic membrane. Discontinue promptly if sensitization or irritation occurs. Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.

Source: US FDA prescribing information

Side effects

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported. Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Stinging and burning have been reported rarely when this drug has gained access to the middle ear.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

9 presentations of Hydrocortisone, Neomycin and Polymyxin b, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/3.5 mg/10000 units per mL ear dropsOticHydrocortisone, Neomycin and Polymyxin bBausch & Lomb IncoporatedUS FDAAvailable on request
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/3.5 mg/10000 units per mL otic suspensionOticHydrocortisone, Neomycin and Polymyxin bSandozUS FDAAvailable on request
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/3.5 mg/10000 units per mL otic suspensionOticHydrocortisone, Neomycin and Polymyxin bBausch & LombUS FDAAvailable on request
Hydrocortisone, Neomycin and Polymyxin b 10 mg/3.5 mg/10000 units per mL otic suspensionOticGeneric nameHydrocortisone, Neomycin and Polymyxin b—US FDAAvailable on request
Hydrocortisone, Neomycin and Polymyxin b 10 mg/3.5 mg/10000 IU per mL ear dropsOticGeneric nameHydrocortisone, Neomycin and Polymyxin b—US FDAAvailable on request
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/3.5 mg/10000 IU per mL otic solutionOticHydrocortisone, Neomycin and Polymyxin bSandozUS FDAAvailable on request
Neomycin And Polymyxin B Sulfates And Hydrocortisone 10 mg/3.5 mg/10000 units per mL ear dropsOticHydrocortisone, Neomycin and Polymyxin bAmneal Pharmaceuticals NYUS FDAAvailable on request
Neomycin And Polymyxin B Sulfates And Hydrocortisone 10 mg/3.5 mg/10000 units per mL otic suspensionOticHydrocortisone, Neomycin and Polymyxin bAmneal Pharmaceuticals NYUS FDAAvailable on request
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/3.5 mg/10000 units per mL ophthalmic suspensionOphthalmicHydrocortisone, Neomycin and Polymyxin bSandozUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 April 1963Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Hydrocortisone, Neomycin and Polymyxin b available for export from India?

Yes, on request. MedsAcross lists 9 presentations of Hydrocortisone, Neomycin and Polymyxin b and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Hydrocortisone, Neomycin and Polymyxin b have?

The catalogue lists 2 brand names for Hydrocortisone, Neomycin and Polymyxin b, including Neomycin And Polymyxin B Sulfates And Hydrocortisone, Neomycin and Polymyxin B Sulfates and Hydrocortisone.

Is Hydrocortisone, Neomycin and Polymyxin b approved by the US FDA?

Yes. The US FDA first approved Hydrocortisone, Neomycin and Polymyxin b on 16 April 1963, according to Drugs@FDA.

Does Hydrocortisone, Neomycin and Polymyxin b need cold chain shipping?

No listed presentation of Hydrocortisone, Neomycin and Polymyxin b is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension prescribing information (Rising Pharma Holdings). U.S. National Library of Medicine, DailyMed. Retrieved 10 June 2024

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