Cortisporin®-TC Otic Suspension 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, 3mg (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.

  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.

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.

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 longstanding 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 pediatric patients, 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 pediatric patients) 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.

HOW SUPPLIED

Cortisporin®-TC Otic Suspension is supplied as:

NDC 61570-090-10 ......................... 10-mL bottle with dropper

Each mL contains: Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate. Thimerosal (mercury derivative) 0.002% added as a preservative.

A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package.

Shake well before using.

Store at controlled room temperature 15°-30° C (59°-86° F). Stable for 18 months at room temperature; prolonged exposure to higher temperatures should be avoided.

Rx only.

Distributed by:

Monarch Pharmaceuticals, Inc.

Bristol, TN 37620

Manufactured by:

Parkedale Pharmaceuticals, Inc.

Rochester, MI 48307

Rev. 3/98

090G030

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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