Cortisporin-TC

CORTISPORIN-TC- colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate suspension
JHP Pharmaceuticals LLC

DESCRIPTION

Cortisporin® -TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension) is a sterile antibacterial and anti-inflammatory 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%, is 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.

The structural formulas of colistin sulfate (mixture of Colistin A & B), neomycin sulfate (mixture of neomycin A, B & C), hydrocortisone acetate ((11β)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are represented below:

Chemical Structure

Thonzonium Bromide

Chemical Structure
(click image for full-size original)

Colistin sulfate

Chemical Structure

Neomycin A

Chemical Structure
(click image for full-size original)

Neomycin B Sulfate

Chemical Structure

Hydrocortisone Acetate

Chemical Structure
(click image for full-size original)

Neomycin C Sulfate

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.

Microbiology

Together, colistin sulfate and neomycin sulfate have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-positive microorganisms:

Staphylococcus aureus.

Aerobic gram-negative microorganisms:

Enterobacter aerogenes
Escherichia coli
Klebsiella pneumoniae
Pseudomonas aeruginosa.

Susceptibility Tests

It is not recommended that colistin sulfate or neomycin sulfate be routinely tested and reported by clinical microbiology laboratories.

Cortisporin-TC Indications and Usage

Cortisporin® -TC Otic Suspension is indicated 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.

This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).

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. Cortisporin® -TC Otic Suspension 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.

Information for Patients

Avoid contaminating the dropper with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved.

If sensitization or irritation occurs, discontinue use immediately and contact your physician.

Do not use in the eyes.

If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to avoid loss of potency.

SHAKE WELL BEFORE USING.

Laboratory Tests

Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies have not been performed with colistin or neomycin, or Cortisporin® -TC Otic Suspension. An increased incidence of chromosome aberrations in human lymphocytes has been reported following in vitro exposure to colistin or neomycin.

Fertility studies have not been performed with neomycin, but reports from the scientific literature suggest that it may decrease spermatogenesis in rats. No adverse effects on fertility were observed in male or female rats given intramuscular doses of colistimethate sodium, the methanesulfonate salt of colistin, up to 20 mg/kg (equivalent to 9.3 mg/kg of colistin base). This is approximately 30 times the clinical daily dose based on body surface area, assuming 100% absorption from the ear; however, significant systemic levels of colistin or neomycin would not be anticipated in humans when Cortisporin® -TC Otic Suspension is used as directed.

Long term studies in rodents showed no evidence of carcinogenicity attributable to oral administration of corticosteroids. Mutagenicity studies with hydrocortisone were negative. Studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

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