Colistin/Hydrocortisone/Neomycin/Thonzonium Otic

DEA Class; Rx

Common Brand Names; Coly-Mycin S, Cortisporin-TC Otic

Indicated for the treatment of superficial bacterial infections of the external auditory canal (i.e., otitis externa) caused by susceptible organisms, and for the treatment of infections of mastoidectomy and fenestration cavities caused by susceptible organisms.

Hypersensitivity

Do not use if external auditory canal disorder is suspected or known to be due to cutaneous viral infection (eg, herpes simplex virus, varicella-zoster virus)

Neomycin

• Skin sensitization

• Ototoxicity

• Nephrotoxicity

Hydrocortisone

• Burning

• Itching

• Irritation

• Dryness

• Folliculitis

• Hypertrichosis

• Acneiform eruptions

• Hypopigmentation

• Perioral dermatitis

• Allergic contact dermatitis

• Skin maceration

• Secondary infection

• Skin atrophy

• Striae

• Miliaria

For otic use only

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in organ of Corti; the risk is greater with prolonged use

Therapy should be limited to 10 consecutive days; patients being treated with eardrops containing neomycin should be under close clinical observation

Should be used cautiously in any patient with a perforated tympanic membrane

Neomycin sulfate may cause cutaneous sensitization; a precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known; discontinue promptly if sensitivity or irritation occurs

When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin

The manifestation of sensitization to neomycin is usually alow-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal

Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed; these symptoms regress quickly on withdrawing the medication; neomycin containing applications should be avoided for the patient thereafter

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 changed

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 treatment of future infections

Not for use in eyes

There are no adequate and well-controlled studies of this drug in pregnant women; not known whether therapy can cause fetal harm when administered to a pregnant woman

Hydrocortisone and colistin sulfate appears in human milk following oral administration of the drugs; since systemic absorption of these drugs may occur when they are used topically, use caution when drug is used by a nursing woman