Monograph: |
Colistin Sulfate; Hydrocortisone Acetate; Neomycin Sulfate; Thonzonium Bromide
DESCRIPTION:
Coly-Mycin S Otic with neomycin and hydrocortisone (colistin sulfate-neomycin sulfate-thonzonium bromide-hydrocortisone acetate otic suspension) is a sterile aqueous suspension containing in each ml: colistin base activity, 3 mg (as the sulfate); neomycin base activity, 3.3 mg (as the sulfate); hydrocortisone acetate, 10 mg (1%); thonzonium bromide, 0.5 mg (0.05%); polysorbate 80, acetic acid, and sodium acetate in a buffered aqueous vehicle. Thimerosal (mercury derivative) 0.002%, added as a preservative. It is a nonviscous liquid, buffered at pH 5, for instillation into the canal of the external ear or direct application to the affected aural skin.
CLINICAL PHARMACOLOGY:
1. Colistin Sulfate: an antibiotic with bactericidal action against most gram-negative organisms, notably Pseudomonas aeruginosa, E coli and Klebsiella-Aerobacter .
2. Neomycin Sulfate: a broad-spectrum antibiotic bactericidal to many pathogens, notably Staph aureus and Proteus sp.
3. Hydrocortisone Acetate: a corticosteroid that controls inflammation, edema, pruritus and other dermal reactions.
4. Thonzonium Bromide: a surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate.
INDICATIONS AND USAGE:
For the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.
CONTRAINDICATIONS:
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia and varicella.
WARNINGS:
As with other antibiotic preparations, prolonged treatment may result in overgrowth of nonsusceptible organisms and fungi.
If the infection is not improved after one week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
Patients who prefer to warm the medication before using should be cautioned against heating the suspension above body temperature, in order to avoid loss of potency.
PRECAUTIONS:
General
If sensitization or irritation occurs, medication should be discontinued promptly.
This drug should be used with care in cases of perforated eardrum and in long-standing cases of chronic otitis media because of the possibility of ototoxicity caused by neomycin.
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 following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
ADVERSE REACTIONS:
Neomycin is a not uncommon cutaneous sensitizer. There are articles in the current literature that indicate an increase in the prevalence of persons sensitive to neomycin.
DOSAGE AND ADMINISTRATION:
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 infants and children, 4 drops are suggested because of the smaller capacity of the ear canal.
This dosage correlates to the 4 drops (for adults) and 3 drops (for children) recommended when using the dropper-bottle container for this product.
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.
Shake well before using.
Store at controlled room temperature 15Β°-30Β°C (59Β°-86Β°F). Stable for 18 months at room temperature; prolonged exposure to higher temperatures should be avoided.
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