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
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