"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
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 PRECAUTIONS - General). Patients being treated with eardrops containing neomycin should be under close clinical observation. PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® 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.
As with other antibacterial preparations, prolonged use may result in overgrowth of non-susceptible 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.
Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.
Pregnancy Category C. 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. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® is used by a nursing woman.
The safety and effectiveness of PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® in otitis externa have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age.1
Clinical studies of PEDIOTIC (neomycin, polymyxin b and hydrocortisone) ® 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.
1. Jones RN, Milazzo J, Seidlin M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surgery 1997; 123:1193-1200.
Last reviewed on RxList: 2/23/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Pediotic Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.