Cortisporin (Hydrocortisone – Neomycin – Polymyxin B)

CORTISPORIN®

Glaxo Wellcome

Hydrocortisone – Neomycin – Polymyxin B Compound

Anti-inflammatory – Antibacterial

Action And Clinical Pharmacology: Corticosteroids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticosteroids 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 and neomycin sulfate together are considered active against the following microorganisms: S. aureus, E. coli, H. influenzae, Klebsiella-Enterobacter species, Neisseria species and P. aeruginosa. This product does not provide adequate coverage against S. marcescens and Streptococci, including S. pneumoniae.

When used topically, polymyxin B, bacitracin and neomycin are rarely irritating and absorption from the intact skin or mucous membrane is insignificant. The incidence of skin sensitization to this combination has been shown to be low on normal skin. Since these antibiotics are seldom used systemically, the patient is spared sensitization to those antibiotics which might later be required systemically.

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

Indications And Clinical Uses: Eye/Ear Suspension: For the treatment of non-purulent bacterial, allergic, vernal and phlyctenular conjunctivitis; nonpurulent blepharitis and episcleritis; interstitial, sclerosing, postoperative or acne rosacea keratitis; chemical and thermal burns of the cornea; superficial bacterial infections of the external auditory canal; infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

Ointment: Inflammation of anterior segment of eye; skin infections and inflammation.

Ophthalmic Ointment: For the treatment of nonpurulent bacterial, allergic, vernal and phlyctenular conjunctivitis; nonpurulent blepharitis and episcleritis; interstitial, sclerosing, postoperative or acne rosacea keratitis, chemical and thermal burns of the cornea.

Otic Solution: For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

Children: Caution: Safety of corticosteroid in children of the age group 2 years or below has not been established.

Contra-Indications: Eye/Ear Suspension and Ophthalmic Ointment: In acute purulent conjunctivitis and blepharitis; mycobacterial, fungal or viral lesions of the skin or eye, including herpes simplex, vaccinia, varicella and dendritic keratitis; and in conditions involving the posterior segment of the eye.

For otic use this product is contraindicated in tuberculous, fungal or viral lesions.

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Only the ophthalmic 3.5 g tube is for use in the eyes and not the regular topical ointment.

Ointment not for use in the external ear canal if the eardrum is perforated.

A possibility of increased neomycin absorption exists in neonates and infants, thus Cortisporin is not recommended for use in neonates, and should be used at reduced dosages in infants.

Manufacturers’ Warnings In Clinical States: 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 usually a low-grade reddening with swelling, dry scaling and itching. It may be manifested 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.

Neomycin may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.

In neonates and infants, absorption by immature skin may be enhanced. Immaturity of renal function may predispose these patients to decreased elimination and increased blood levels.

Ophthalmic Ointment: Use of steroid medication in the treatment of herpes simplex requires great caution.

Acute purulent untreated infections of the eye may be masked or enhanced by the presence of a steroid.

Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, the ointment should not be used over a wide area or for extended periods of time.

Prolonged ophthalmic use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Eye/Ear Suspension: The eye/ear suspension should be used with caution in cases of perforated ear drum and in long-standing cases of chronic otitis media, because of the possibility of ototoxicity. In otic use, ototoxicity has been reported (see Adverse Effects).

Prolonged ophthalmic use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and unco-operative patients.

Otic Solution: The otic solution should be used with care when the integrity of the tympanic membrane is in question because of the possibility of ototoxicity caused by neomycin. Stinging and burning may occur when this product gains access to the middle ear.

The otic solution contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions: As with any antibiotic preparation, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi. The possibility of persistent fungal infections of the cornea and ear should be considered after prolonged steroid dosing. Appropriate measures should be taken if this occurs. 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.

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.

Treatment with the otic solution 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.

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.

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

Pregnancy and Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity, thus use of Cortisporin is not recommended in pregnancy and lactation.

Children: Safety of corticosteroids in children aged 2 years or younger has not been established. Sufficient absorption of hydrocortisone can occur in infants and children during prolonged use to cause cessation of growth, as well as other systemic signs and symptoms of hyperadrenocorticism.

Use of steroids on infected areas should be supervised with care as anti-inflammatory steroids may encourage spread of infection. If this occurs steroid therapy should be stopped and appropriate antibacterial drugs used. Generalized dermatological conditions may require systemic corticosteroid therapy.

The initial prescription and renewal of the eye/ear suspension order beyond 10 days or of the ophthalmic ointment beyond 7 g should be made by a physician only after examination of the patient; in the case of ophthalmic use, with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Information for the Patient: Eye/Ear Suspension and Otic Solution: 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.

Eye/Ear Suspension: Shake well before using.

Otic Solution: Do not use in the eyes.

If redness, irritation, swelling or pain persists or increases, discontinue use and notify physician.

Adverse Reactions: Neomycin occasionally causes skin sensitization. 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 2 of 2.175 (0.09%) individuals in the general population. In another study, the incidence was found to be approximately 1%. When steroid preparations are used for long periods of time in intertriginous areas or over extensive body areas, with or without occlusive nonpermeable dressings, striae may occur; also there exists the possibility of systemic adverse effects when steroid preparations are used over larger areas or for a long period of time.

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, milaria.

Eye/Ear Suspension and Sterile Ophthalmic Ointment: Reactions occurring most often from the presence of the anti-infective ingredient in ophthalmic use are localized hypersensitivity, including itching, swelling and conjunctival erythema. Local irritation on instillation has also been reported.

The reactions due to the steroid component, in decreasing order of frequency, are elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.

In otic use, ototoxicity and nephrotoxcity have also been reported (see Warnings).

Stinging and burning have been reported rarely when this product has gained access to the middle ear.

Otic Solution: Stinging and burning have been reported when this product has gained access to the middle ear.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial infection following suppression of host responses also occurs.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Treatment is symptomatic.

Dosage And Administration: A possibility of increased neomycin absorption exists in neonates and infants, thus Cortisporin is not recommended for use in neonates, and should be used at reduced dosages in infants.

Eye/Ear Suspension: Ophthalmic: 1 or 2 drops in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Otic: The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. Three or 4 drops in the ear 3 to 4 times daily. For infants and children, the dose should be reduced, 3 drops are suggested because of the smaller capacity of the ear canal.

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 solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.

Not more than a 10-day supply should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in Precautions.

The patient should be instructed to avoid contaminating the dropper with material from the eye, ear, fingers, or other sources. This caution is necessary if the sterility of the suspension is to be preserved.

Shake well before using.

Ointment: Apply thin film 2 to 4 times daily.

Ophthalmic Ointment: Apply in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Otic Solution: Adults: 4 drops of the solution should be instilled into the affected ear 3 or 4 times daily. Infants and Children: 3 drops are suggested because of the smaller capacity of the ear canal.

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 solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.

Availability And Storage: Eye/Ear Suspension: Each mL of sterile eye/ear suspension contains: polymyxin B sulfate 10 000 units, neomycin sulfate equivalent to 3.5 mg neomycin base and hydrocortisone 10 mg (1%). Nonmedicinal ingredients: benzalkonium chloride (preservative), cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyethylene stearate, propylene glycol, sulfuric acid (may be added to adjust pH) and water for injection. Bottles of 10 mL.

Ointment: Each g of ointment contains: polymyxin B sulfate 5 000 units, zinc bacitracin 400 units, neomycin sulfate 5 mg, hydrocortisone 10 mg in a low melting point petrolatum base. Tubes of 15 g.

Ophthalmic Ointment: Each g of sterile ophthalmic ointment contains: polymyxin B sulfate 10 000 units, zinc bacitracin 400 units, neomycin sulfate 5 mg, hydrocortisone 10 mg in a low melting point petrolatum base. Tubes of 3.5 g.

Otic Solution: Each mL of sterile otic solution contains: polymyxin B sulfate 10 000 units, neomycin sulfate equivalent to 3.5 mg neomycin base, and hydrocortisone 10 mg (1%). Nonmedicinal ingredients: cupric sulfate, glycerin, potassium metabisulfite and propylene glycol. Bottles of 10 mL with sterilized dropper.

Store between 15 and 25°C.

CORTISPORIN® Glaxo Wellcome Hydrocortisone – Neomycin – Polymyxin B Compound Anti-inflammatory – Antibacterial

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