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Cortisporin Ointment (Neomycin Sulfate Polymyxin B Sulfate Bacitracin Zinc Hydrocor)
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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. PolymyxinB sulfate 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, bacitracin zinc, polymyxin B sulfate and neomycin sulfate are rarely irritating and are not absorbed systemically in significant amounts through intact skin or mucous membrane, but the possibility of significant absorption exists when extensive raw areas are being treated. 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.
Hydrocortisone is partially absorbed through intact skin and this absorption is enhanced when the skin is broken or occluded.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
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. PolymyxinB sulfate 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, bacitracin zinc, polymyxin B sulfate and neomycin sulfate are rarely irritating and are not absorbed systemically in significant amounts through intact skin or mucous membrane, but the possibility of significant absorption exists when extensive raw areas are being treated. 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.
Hydrocortisone is partially absorbed through intact skin and this absorption is enhanced when the skin is broken or occluded.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
Indications
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. PolymyxinB Sulfate 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, Bacitracin Zinc, Polymyxin B Sulfate And Neomycin Sulfate Are Rarely Irritating And Are Not Absorbed Systemically In Significant Amounts Through Intact Skin Or Mucous Membrane, But The Possibility Of Significant Absorption Exists When Extensive Raw Areas Are Being Treated. 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.
Hydrocortisone Is Partially Absorbed Through Intact Skin And This Absorption Is Enhanced When The Skin Is Broken Or Occluded.
The Relative Potency Of Corticosteroids Depends On The Molecular Structure, Concentration, And Release From The Vehicle.
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. PolymyxinB Sulfate 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, Bacitracin Zinc, Polymyxin B Sulfate And Neomycin Sulfate Are Rarely Irritating And Are Not Absorbed Systemically In Significant Amounts Through Intact Skin Or Mucous Membrane, But The Possibility Of Significant Absorption Exists When Extensive Raw Areas Are Being Treated. 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.
Hydrocortisone Is Partially Absorbed Through Intact Skin And This Absorption Is Enhanced When The Skin Is Broken Or Occluded.
The Relative Potency Of Corticosteroids Depends On The Molecular Structure, Concentration, And Release From The Vehicle.
Contraindications
The ointment should not be used to treat otitis externa in the presence of a perforated tympanic membrane because of the risk of ototoxicity.
Only the sterile ophthalmic 3.5g tube is for use in the eyes and not the regular topical ointment.
The use of Cortisporin ointment is contraindicated in patients who have demonstrated allergic hypersensitivity to any of the components of the preparation or to cross-sensitizing substances such as aminoglycosides and other related antibiotics.
The presence of pre-existing nerve deafness is a contraindication to the use of Cortisporin ointment in circumstances in which significant systemic absorption could occur.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cortisporin in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
Viral, tuberculous, primary bacterial and fungal infections of the skin are contraindications to the use of Cortisporin ointment.
A possibility of increased neomycin absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (up to 2years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
The ointment should not be used to treat otitis externa in the presence of a perforated tympanic membrane because of the risk of ototoxicity.
Only the sterile ophthalmic 3.5g tube is for use in the eyes and not the regular topical ointment.
The use of Cortisporin ointment is contraindicated in patients who have demonstrated allergic hypersensitivity to any of the components of the preparation or to cross-sensitizing substances such as aminoglycosides and other related antibiotics.
The presence of pre-existing nerve deafness is a contraindication to the use of Cortisporin ointment in circumstances in which significant systemic absorption could occur.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cortisporin in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
Viral, tuberculous, primary bacterial and fungal infections of the skin are contraindications to the use of Cortisporin ointment.
A possibility of increased neomycin absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (up to 2years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Safety Information / Warning
The concurrent use of other aminoglycoside antibiotics is not recommended in circumstances where significant systemic absorption of neomycin sulfate following topical application could occur.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.
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.
Following significant systemic absorption: aminoglycosides such as neomycin can cause irreversible ototoxicity; neomycin sulfate, polymyxin B sulfate and bacitracin zinc have nephrotoxic potential; polymyxin B sulfate has neurotoxic potential.
The concurrent use of other aminoglycoside antibiotics is not recommended in circumstances where significant systemic absorption of neomycin sulfate following topical application could occur.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.
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.
Following significant systemic absorption: aminoglycosides such as neomycin can cause irreversible ototoxicity; neomycin sulfate, polymyxin B sulfate and bacitracin zinc have nephrotoxic potential; polymyxin B sulfate has neurotoxic potential.
Precautions
General 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.
The use of Cortisporin ointment should not be continued for more than 7 days in the absence of any clinical improvement. 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.
Hydrocortisone may mask the allergic effects produced by any component of Cortisporin ointment.
Signs and symptoms of exogenous hyperadrenocorticism, including adrenal suppression, can occur with the use of topical corticosteroids. Systemic absorption of topically applied steroids will be increased if extensive body suface areas are treated or if occlusive dressings are used. Under these circumstances, suitable precautions should be taken when long-term use is anticipated.
Geriatrics: Cortisporin ointment is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see Dosage).
Children: Cortisporin ointment is suitable for use in children (2years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (<2 years) (see Contraindications and Dosage).
Pregnancy: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy. 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 ointment is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus use of Cortisporin ointment is not recommended in nursing mothers.
Patients with Special Diseases and Conditions: In renal impairment, the plasma clearance of neomycin is reduced (see Dosage).
Drug Interactions : Following significant systemic absorption, both neomycin sulfate and polymyxin B sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents. However, the neuromuscular blocking activity of neomycin sulfate and polymyxin B sulfate is unlikely to present a hazard during use of Cortisporin ointment.
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.
General 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.
The use of Cortisporin ointment should not be continued for more than 7 days in the absence of any clinical improvement. 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.
Hydrocortisone may mask the allergic effects produced by any component of Cortisporin ointment.
Signs and symptoms of exogenous hyperadrenocorticism, including adrenal suppression, can occur with the use of topical corticosteroids. Systemic absorption of topically applied steroids will be increased if extensive body suface areas are treated or if occlusive dressings are used. Under these circumstances, suitable precautions should be taken when long-term use is anticipated.
Geriatrics: Cortisporin ointment is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see Dosage).
Children: Cortisporin ointment is suitable for use in children (2years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (<2 years) (see Contraindications and Dosage).
Pregnancy: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy. 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 ointment is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus use of Cortisporin ointment is not recommended in nursing mothers.
Patients with Special Diseases and Conditions: In renal impairment, the plasma clearance of neomycin is reduced (see Dosage).
Drug Interactions : Following significant systemic absorption, both neomycin sulfate and polymyxin B sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents. However, the neuromuscular blocking activity of neomycin sulfate and polymyxin B sulfate is unlikely to present a hazard during use of Cortisporin ointment.
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.
Side Effects / Adverse Effects
Adverse reactions have occurred with topical use of antibiotic combinations containing 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 2175 (0.09%) individuals in the general population. In another study, the incidence was found to be approximately 1%.
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensivity to neomycin sulfate in certain selected groups of patients in dermatological practice, in particular venous stasis eczema and ulceration, and chronic otitis externa.
Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching of the affected skin, or as a failure of the lesion to heal.
Allergic hypersensitivity reactions following the topical administration of bacitracin zinc, hydrocortisone and polymyxin B sulfate are rare events.
Anaphylactic reactions following the topical application of bacitracin zinc have been reported, but are rare events.
Topically applied hydrocortisone may produce skin atrophy such as telangiectasiae and striae. However, this effect only occurs following prolonged use, high dosage, occlusion of the topical site (for example by plastic or by natural occlusion as in the groin), and particularly applies to infants and young children. The possibility of systemic adverse effects when steroid preparations are used over larger areas or for a long period of time also exists.
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.
Adverse reactions have occurred with topical use of antibiotic combinations containing 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 2175 (0.09%) individuals in the general population. In another study, the incidence was found to be approximately 1%.
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensivity to neomycin sulfate in certain selected groups of patients in dermatological practice, in particular venous stasis eczema and ulceration, and chronic otitis externa.
Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching of the affected skin, or as a failure of the lesion to heal.
Allergic hypersensitivity reactions following the topical administration of bacitracin zinc, hydrocortisone and polymyxin B sulfate are rare events.
Anaphylactic reactions following the topical application of bacitracin zinc have been reported, but are rare events.
Topically applied hydrocortisone may produce skin atrophy such as telangiectasiae and striae. However, this effect only occurs following prolonged use, high dosage, occlusion of the topical site (for example by plastic or by natural occlusion as in the groin), and particularly applies to infants and young children. The possibility of systemic adverse effects when steroid preparations are used over larger areas or for a long period of time also exists.
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.
Overdose
No information is available concerning accidental ingestion of Cortisporin ointment.
Symptoms:
No specific symptoms or signs have been associated with excessive use of Cortisporin ointment. However, consideration should be given to significant systemic absorption (see Contraindications, Warnings, and Precautions).
Treatment: Use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.
Blood levels of neomycin sulfate and bacitracin zinc should also be determined, and hemodialysis may reduce the serum level of neomycin sulfate.
No information is available concerning accidental ingestion of Cortisporin ointment.
Symptoms:
No specific symptoms or signs have been associated with excessive use of Cortisporin ointment. However, consideration should be given to significant systemic absorption (see Contraindications, Warnings, and Precautions).
Treatment: Use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.
Blood levels of neomycin sulfate and bacitracin zinc should also be determined, and hemodialysis may reduce the serum level of neomycin sulfate.
Recommended Dosage
Prior to treatment, remove any debris such as pus, crusts, etc. from the affected area.
Treatment should not be continued for more than 7 days without medical supervision.
Dilution of Cortisporin ointment is not recommended; reduction of the antibiotic concentrations may reduce their therapeutic efficacy.
Adults: Apply a thin film of ointment to the affected area 2to 4times per day, depending on the clinical condition.
Children: Cortisporin ointment is suitable for use in children (2years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (<2years) (see Contraindications and Precautions).
Geriatrics: Cortisporin ointment is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur.
Dosage in Renal Impairment: Dosage should be reduced in patients with reduced renal function (see Warnings and Precautions).
Prior to treatment, remove any debris such as pus, crusts, etc. from the affected area.
Treatment should not be continued for more than 7 days without medical supervision.
Dilution of Cortisporin ointment is not recommended; reduction of the antibiotic concentrations may reduce their therapeutic efficacy.
Adults: Apply a thin film of ointment to the affected area 2to 4times per day, depending on the clinical condition.
Children: Cortisporin ointment is suitable for use in children (2years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ointment is not recommended for use in neonates and infants (<2years) (see Contraindications and Precautions).
Geriatrics: Cortisporin ointment is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur.
Dosage in Renal Impairment: Dosage should be reduced in patients with reduced renal function (see Warnings and Precautions).
Supplied / Packaging
Each g of ointment contains: polymyxin B sulfate 5000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg and hydrocortisone 10 mg in a low melting point petrolatum. Tubes of 15 g. Store between 15 and 25°C.
Each g of ointment contains: polymyxin B sulfate 5000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg and hydrocortisone 10 mg in a low melting point petrolatum. Tubes of 15 g. Store between 15 and 25°C.
