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.
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: Teratogenic Effects: 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
Nursing Mothers: 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 CORTISPORIN Otic
Solution is used by a nursing woman.
Pediatric Use: The safety and effectiveness of CORTISPORIN Otic Solution (neomycin and polymyxin b sulfates and hydrocortisone otic solution)
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
Geriatric Use: Clinical studies of CORTISPORIN Otic Solution (neomycin and polymyxin b sulfates and hydrocortisone otic solution) 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
1. Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123: 1193-1200.