Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is a Sterile Antibacterial and Anti-Inflammatory Suspension for otic use.

Indicated 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. This product is contraindicated in persons who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia and varicella infections. Warnings: 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, USP 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.

When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.

For additional information, see prescribing info link below.

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     Hydrocortisone Otic Suspension, USP Prescribing Info

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