As with any other antibiotic preparation, prolonged
treatment may result in overgrowth of nonsusceptible organisms and fungi. If
the infection is not improved after one week, cultures should be repeated to
verify the identity of the organism and to determine whether therapy should be
Treatment should not be continued for longer than ten days.
Allergic cross-reactions may occur which could prevent the
use of any or all of the aminoglycoside antibiotics for the treatment of future
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 animal carcinogenicity studies have not been
performed with colistin or neomycin, or Coly- Mycin® S Otic. An increased
incidence of chromosome aberrations in human lymphocytes has been reported
following in vitro exposure to colistin or neomycin.
Fertility studies have not been performed with neomycin, but
reports from the scientific literature suggest that it may decrease
spermatogenesis in rats. No adverse effects on fertility were observed in male
or female rats given intramuscular doses of colistimethate sodium, the
methanesulfonate salt of colistin, up to 20 mg/kg (equivalent to 9.3 mg/kg of
colistin base). This is approximately 30 times the clinical daily dose based on
body surface area, assuming 100% absorption from the ear; however, significant
systemic levels of colistin or neomycin would not be anticipated in humans when
Coly-Mycin® S Otic is used as directed.
Long term studies in rodents showed no evidence of
carcinogenicity attributable to oral administration of corticosteroids.
Mutagenicity studies with hydrocortisone were negative. Studies have not been
performed to evaluate the effect on fertility of topical corticosteroids.
Pregnancy Category C
There are no adequate and well controlled studies of Coly-Mycin® S Otic
in pregnant women. It is not known whether Coly-Mycin® S Otic can cause
fetal harm when administered to a pregnant woman.
Colistimethate sodium, the methanesulfonate salt of
colistin, was not teratogenic in rats or rabbits given intramuscular doses up
to 20 mg/kg (equivalent to 9.3 mg/kg of colisitin base, approximately 30 times
(rats) or 55 times (rabbits) the clinical daily dose based on body suface area
and assuming 100% absorption from the ear). Increased resorptions were observed
in rabbits at 20 mg/kg, but not 10 mg/kg (equivalent to 4.15 mg/kg of colistin
base). Decreased pup survival at weaning was observed in rats at 20 mg/kg, a
maternally toxic dose of colistin, but not 10 mg/kg. Colistin has not been
shown to have any adverse effects on the developing embryo or fetus at doses
relevant to the amount that will be delivered ototopically at the recommended
Although aminoglycosides can cause congenital deafness in
humans if administered during pregnancy, significant systemic levels of neomycin
would not be anticipated when Coly-Mycin® S Otic is used as directed.
Corticosteroids are generally teratogenic in laboratory
animals when administered systemically at relatively low dosage levels. The
more potent corticosteroids have been shown to be teratogenic after dermal
application in laboratory animals.
Coly-Mycin® S Otic should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Hydrocortisone and colistin sulfate appear in human milk
following oral administration of the drugs. Since systemic absorption of these
drugs may occur when they are used topically, caution should be exercised when
Coly-Mycin® S Otic Suspension is used by a nursing woman.
See DOSAGE AND ADMINISTRATION. The safety and
effectiveness of Coly-Mycin® S Otic in infants below one year of age have not
been established. The efficacy of Coly-Mycin® S Otic in pediatric patients one
year or older in the treatment of superficial bacterial infections of the
external auditory canal and for the treatment of infections of mastoidectomy
and fenestration cavities has been demonstrated in a controlled clinical trial.
No overall differences in safety or effectiveness have been
observed between elderly and younger patients.