Polymyxin B / Neomycin Sulfate / Hydrocortisone

What it is and how it works

Mechanism class: Corticosteroid Hormone Receptor Agonists

Indications

INDICATIONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three 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.

Contraindications

CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).

Warnings and precautions

WARNINGS Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use; therefore, duration of therapy should be limited to 10 consecutive days (see PRECAUTIONS - General ). Patients being treated with eardrops containing neomycin should be under close clinical observation.

Pregnancy

Pregnancy Teratogenic Effects Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women.

Storage and supply

HOW SUPPLIED Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is supplied in a white plastic dropper bottle in the following size: NDC: 70518-0763-00 PACKAGING: 1 in 1 CARTON, 10 mL in 1 BOTTLE DROPPER TYPE 0 Storage:Store between 15°C to 25°C (59°F to 77°F). Securely tighten cap between uses. Keep out of reach of children.

Source: Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone (Neomycin And Polymyxin B Sulfates And Hydrocortisone) — US FDA prescribing information, 2026-01-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.