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
Systemic effects of excessive levels of hydrocortisone may include a reduction
in the number of circulating eosinophils and a decrease in urinary excretion of 17hydroxycorticosteroids.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals (rats,
rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of
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 CASPORYN HC Otic Suspension is used by a nursing woman.
The safety and effectiveness of CASPORYN HC Otic Suspension in otitis extema have been established in the pediatric age group.
Clinical studies of CASPORYN HC 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.