CORTISPORIN Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ointment, USP) is a topical antibacterial ointment. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 5,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum, qs.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B₁ and B₂, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis (Fam. Bacillaceae). It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

Hydrocortisone, 11β,17,21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

For the treatment of corticosteroid responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment. (See WARNINGS.)

Therapy with this product should be limited to 7 days. A thin film is applied 2 to 4 times daily to the affected area.

Tube of 1/2 oz with applicator tip (NDC 61570-031-50).

Store at 15° to 25°C (59° to 77°F).

Prescribing Information as of September 2003. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: King Pharmaceuticals, Inc., Bristol, TN 37620. FDA Rev date: 11/21/2003

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, bacitracin, 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.¹ In another study, the incidence was found to be approximately 1%.²

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. When steroid preparations are used for long periods of time in intertriginous areas or over extensive body areas, with or without occlusive non-permeable dressings, striae may occur; also there exists the possibility of systemic side effects when steroid preparations are used over large areas or for a long period of time.

No information provided.

REFERENCES:

1. Leyden JJ, Kligman AM. Contact dermatitis to neomycin sulfate. JAMA. 1979;242:1276-1278.

2. Prystowsky SD, Allen AM, Smith RW, et al. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine. Arch Dermatol. 1979;115:959-962.

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use. Therapy with this product should be limited to 7 days of treatment. (See INDICATIONS AND USAGE.)

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 sensitization or irritation occurs.

When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis extema 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 usually 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.

General: As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Treatment should not be continued for longer than 7 days. 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. Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections. Use of steroids on infected areas should be supervised with care as anti-inflammatory steroids may encourage spread of infections. If this occurs, steroid therapy should be stopped and appropriate antibacterial drugs used. Generalized dermatological conditions may require systemic corticosteroid therapy.

Signs and symptoms of exogenous hyperadrenocorticism can occur with the use of topical corticosteroids, including adrenal suppression. Systemic absorption of topically applied steroids will be increased if extensive body surface areas are treated or if occlusive dressings are used. Under these circumstances, suitable precautions should be taken when long-term use is anticipated.

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: Teratogenic Effects: 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 CORTISPORIN Ointment is used by a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Sufficient percutaneous absorption of hydrocorti- sone can occur in infants and children during prolonged use to cause cessation of growth, as well as other signs and symptoms of hypera- drenocorticism.

Geriatric Use: Clinical studies of Cortisporin Ointment 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 elderly and younger patients.

No information provided.

Not for use in the eyes or in the external ear canal if the eardrum is perforated. This product is contraindicated in tuberculous, fungal, or viral (for example, herpes simplex or varicella zoster) lesions of the skin. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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. Polymyxin B sulfate, bacitracin zinc, and neomycin sulfate together are considered active against the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens.

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

If redness, irritation, swelling, or pain persists or increases, discontinue use and notify physician. Do not use in the eyes.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

NEOMYCIN/BACITRACIN/POLYMYXIN/HYDROCORTISONE - TOPICAL

(nee-oh-MY-sin/bass-eh-TRAY-sin/paw-lee-MIX-in/) (hi-dro-KOR-tih-sown)

COMMON BRAND NAME(S): Cortisporin

USES: This medication is used to treat skin infections. This product contains neomycin, bacitracin, and polymyxin, antibiotics that work by stopping the growth of bacteria. It also contains hydrocortisone, an anti-inflammatory corticosteroid that works by reducing swelling and itching.

This medication treats only bacterial skin infections. It will not work for other types of skin infections (e.g., infections caused by fungi, viruses). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: This medication is for use on the skin only. Wash your hands before using. Clean and dry the affected area as directed. Then apply a small amount of medication in a thin layer on the skin and rub in gently, usually 2 to 4 times a day or as directed by your doctor. Wash your hands after use, unless you are using this product to treat the hands.

Do not bandage, cover, or wrap the treated area unless you are instructed to do so by your doctor. If you are using this medication on a child's diaper area, do not use tight-fitting diapers or plastic pants.

Do not use large amounts of this medication or apply this more often or for a longer period than directed. Your condition will not clear faster, but the risk of side effects may be increased. This product is not recommended for use over a wide area of the body. Do not use this product for longer than 1 week unless directed by your doctor.

Avoid getting this medication in your eyes or inside the mouth. If this occurs, wipe off the medication and rinse thoroughly with water. Do not use inside the nose unless directed by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Inform your doctor if your condition does not improve after 1 week.

SIDE EFFECTS: Burning, redness, irritation, or dryness of the skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (e.g., fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to neomycin, bacitracin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to other corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies.

This medication should not be used to treat an infection in the outer ear canal if the eardrum is torn (perforated).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a weakened immune system.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable effects that may require additional corticosteroid treatment. Children and those using this medication for an extended time over most of the skin may be at higher risk, especially if they also have serious medical problems such as severe infections, injuries, or surgeries. This precaution applies for up to 1 year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and tell them that you use (or have used) this medication.

Caution is advised when using this drug in children. Children may be more sensitive to the effects of large amounts of steroids. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may affect growth in children if used for long periods. Monitor your child's height and rate of growth from time to time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin), corticosteroids taken by mouth (e.g., prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: hearing problems, change in the amount of urine.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, apply the medication as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat with the cap tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.