Drug Class: Otic steroids with anti-infectives
Related/similar drugs
amoxicillin, ciprofloxacin otic, cephalexin, azithromycin, Augmentin, ceftriaxone, amoxicillin / clavulanateColy-Mycin S - Clinical Pharmacology
Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a corticosteroid hormone which is thought to act by regulating the rate of protein synthesis; it controls inflammation, edema, pruritus and other dermal reactions. Cortiscosteroids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
Thonzonium bromide is a surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate.
Warnings
Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days. (See PRECAUTIONS-General.) Patients being treated with eardrops containing neomycin should be under close clinical observation. Coly-Mycin® S Otic 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 ususally a low-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.
Precautions
General
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 the treatment of future infections.
Coly-Mycin S Dosage and Administration
Therapy with this product should be limited to 10 days. (See WARNINGS.)
The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
When using the calibrated dropper:
For adults, 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For pediatric patients, 4 drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.
COLY-MYCIN S
colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate suspension |
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Labeler - Par Pharmaceutical, Inc. (092733690) |