Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension

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, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

HOW SUPPLIED 10 mL bottle (NDC 68788-7787-1). Store at 15° to 25°C (59° to 77°F). Rx only KEEP OUT OF REACH OF CHILDREN. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Code No.: TS/DRUGS/13/2010 Made in India PIA44801-03 Revised: 05/2024 P1537072

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, 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.

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.

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 (see ). 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. 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.

General: As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed. Treatment should not be continued for longer than 10 days. Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients: Avoid contaminating the bottle tip with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved. If sensitization or irritation occurs, discontinue use immediately and contact your physician. SHAKE WELL BEFORE USING.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

Pediatric Use: The safety and effectiveness of neomycin and polymyxin B sulfates and hydrocortisone otic suspension in otitis externa have been established in pediatric patients.

Geriatric Use: Clinical studies of neomycin and polymyxin B sulfates and hydrocortisone otic suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

ADVERSE REACTIONS Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see ). 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. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.