Data from FDA - Curated by EPG Health - Last updated 22 December 2016
PRECAUTIONS General As with any other antibiotic preparation,
Treatment should not be continued for longer than ten days.
If sensitization or
If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to avoid
Laboratory Tests Systemic effects of
Fertility studies have not been performed with neomycin, but reports from the scientific literature suggest that
This is approximately 30 times the clinical daily dose based on body surface area, assuming 100 % absorption from the ear; however,
Studies have not been performed to evaluate the effect on fertility of topical corticosteroids.
Pregnancy Teratogenic Effects Pregnancy Category C There are
It is not known whether Coly-Mycin® S Otic can cause fetal
Colistimethate sodium, the methanesulfonate salt of colistin, was not teratogenic in
Decreased pup survival at weaning was observed in
Colistin has not been shown to have any
Although aminoglycosides can cause congenital
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at
Coly-Mycin®S Otic should be used during pregnancy only if the potential
Nursing Mothers 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,
Pediatric Use See DOSAGE AND ADMINISTRATION.
The efficacy of Coly-Mycin® S Otic in pediatric patients one year or older in the treatment of superficial bacterial
Ototoxicity (see WARNINGS section) and nephrotoxicity have also been reported.
The reaction occurring most often is
In one clinical study, using a 20
In another study the incidence was found to be approximately 1 %.
The following local
To report SUSPECTED
When using the
For pediatric patients, 4 drops are suggested because of the smaller capacity of the ear canal.
This position should be maintained for 5
Repeat, if necessary, for the opposite ear.
This wick should be kept
The wick should be replaced at least once every 24 hours.
|Date Last Revised||17-03-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store at 20°–25°C (68°–77°F). Rx only.|
|Marketing authorisation holder||Par Pharmaceutical, Inc.|