Colistin, neomycin, thonzonium, and hydrocortisone acetate

Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of Cortisporin ® TC Otic in pregnant women. It is not known whether Cortisporin ® TC 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 surface 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 clinical doses. Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, significant systemic levels of neomycin would not be anticipated when Cortisporin ® TC 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. Cortisporin ® TC Otic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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, caution should be exercised when Cortisporin ® TC Otic Suspension is used by a nursing woman.