Cortomycin

Cortomycin is part of the drug classes:

• Corticosteroids acting locally

• Corticosteroids for local oral treatment

• Antiinflammatory Corticosteroids

• Corticosteroids, weak group I

• Corticosteroids, weak, other combinations

• Corticosteroids/antiinfectives/mydriatics in combination

• Glucocorticoids

• Antiinfectives and antiseptics for local oral treatment

• Other aminoglycosides

• Other antibiotics for topical use

• Polymyxins

In the U.S.

• Antibiotic Otic
• Cort-Biotic
• Cortisporin
• Cortomycin
• Oti-Sone
• Pediotic

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Neomycin

This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and hydrocortisone. It may not be specific to Cortomycin. Please read with care.

You may warm the ear drops to body temperature (37 °C or 98.6 °F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.) Your doctor may have inserted a gauze or cotton wick into your ear and may want you to keep the wick moistened with this medicine. Your doctor also may have other directions for you, such as how long you should keep the wick in your ear or when you should return to your doctor to have the wick replaced. If you have any questions about this, check with your doctor.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic (ear drops) dosage forms:
  • For ear canal infection:
    • Adults—Use four drops in the ear three or four times a day.
    • Children—Use three drops in the ear three or four times a day.
  • For mastoid cavity infection:
    • Adults—Use four to ten drops in the ear every six to eight hours.
    • Children—Use four or five drops in the ear every six to eight hours.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Corticoids 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 anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

If the infection is not improved after 1 week, cultures and susceptibility tests 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 10 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.

Information for patients

Avoid contaminating bottle tip 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.

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 studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

Pregnancy

Pregnancy Category C: Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when neomycin and polymyxin B sulfates and hydrocortisone otic solution is used by a nursing woman.

Pediatric use

The safety and effectiveness of neomycin and polymyxin B sulfates and hydrocortisone otic solution in otitis externa have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age 1.

Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123; 1193-1200.

Geriatric use

Clinical studies of neomycin and polymyxin B sulfates and hydrocortisone otic solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. 2 In another study, the incidence was found to be approximately 1%.3

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Stinging and burning have been reported when this product has gained access to the middle ear.

Leyden JJ. Kligman AM. Contact dermatitis to neomycin sulfate. JAMA 1979; 242: 276-1278.

Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odum RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine: relationships between age, sex, history of exposure, and reactivity to standard patch tests and use tests in general population. Arch Dermatol 1979; 115:959-962.

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is supplied in a white plastic dropper bottle in the following size:

10 mL - Prod. No. 10009

STERILE OTIC SOLUTION

Rx only

FOR USE IN THE EARS ONLY

NOT FOR USE IN THE EYES

Applies to hydrocortisone / neomycin / polymyxin b otic: otic solution, otic suspension

Along with its needed effects, hydrocortisone / neomycin / polymyxin b otic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrocortisone / neomycin / polymyxin b otic:

• Itching, skin rash, redness, swelling, or other sign of irritation in or around the ear not present before use of this medicine