Great resource for drug information, reviews and discussions
Cortisporin Ophthalmic Ointment (Neomycin Sulfate Polymyxin B Sulfate Bacitracin Zinc Hydrocor)
How do you rate this drug's effectiveness?
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 zinc and neomycin sulfate together are considered active against the following microorganisms: S.aureus , streptococci including S.pneumoniae , E.coli , H.influenzae , Klebsiella-Enterobacter species, Neisseria species and P.aeruginosa .
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. Polymyxin B sulfate, bacitracin zinc and neomycin sulfate together are considered active against the following microorganisms: S.aureus , streptococci including S.pneumoniae , E.coli , H.influenzae , Klebsiella-Enterobacter species, Neisseria species and P.aeruginosa .
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. Polymyxin B Sulfate, Bacitracin Zinc And Neomycin Sulfate Together Are Considered Active Against The Following Microorganisms: S.aureus , Streptococci Including S.pneumoniae , E.coli , H.influenzae , Klebsiella-Enterobacter Species, Neisseria Species And P.aeruginosa .
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. Polymyxin B Sulfate, Bacitracin Zinc And Neomycin Sulfate Together Are Considered Active Against The Following Microorganisms: S.aureus , Streptococci Including S.pneumoniae , E.coli , H.influenzae , Klebsiella-Enterobacter Species, Neisseria Species And P.aeruginosa .
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
In the presence of: acute purulent conjunctivitis and blepharitis; untreated mycobacterial, fungal or viral lesions of the skin or eye, including Herpes simplex, Herpes zoster, vaccinia, varicella and dendritic keratitis; and in conditions involving the posterior segment of the eye.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cortisporin ophthalmic ointment in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
The use of Cortisporin ophthalmic 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 use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
A possibility of increased neomycin absorption exists in very young children, thus Cortisporin ophthalmic ointment is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
In the presence of: acute purulent conjunctivitis and blepharitis; untreated mycobacterial, fungal or viral lesions of the skin or eye, including Herpes simplex, Herpes zoster, vaccinia, varicella and dendritic keratitis; and in conditions involving the posterior segment of the eye.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cortisporin ophthalmic ointment in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
The use of Cortisporin ophthalmic 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 use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
A possibility of increased neomycin absorption exists in very young children, thus Cortisporin ophthalmic ointment is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Safety Information / Warning
Prolonged use of steroids 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 also 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 under medical supervision, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. 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 and polymyxin B sulfate have nephrotoxic potential; polymyxin B sulfate has neurotoxic potential.
Prolonged use of steroids 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 also 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 under medical supervision, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. 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 and polymyxin B sulfate have nephrotoxic potential; polymyxin B sulfate has neurotoxic potential.
Precautions
General: The use of Cortisporin ophthalmic ointment should not be continued for more than 7 days without medical supervision. 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.
The initial prescription and renewal of the medication order beyond 7 days should be made by a physician only after appropriate examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining (see Warnings).
As with any antibiotic preparation, prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing. Appropriate measures should be taken if this occurs.
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 ophthalmic ointment.
All topically active corticosteroids possess the potential to suppress the pituitary-adrenal axis following systemic absorption. Development of adverse systemic effects due to the hydrocortisone component of ophthalmic ointment is considered to be unlikely, but the recommended dosage should not be exceeded.
Geriatrics: Cortisporin ophthalmic 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 ophthalmic ointment is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ophthalmic 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 ophthalmic 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 ophthalmic 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 ophthalmic 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: The use of Cortisporin ophthalmic ointment should not be continued for more than 7 days without medical supervision. 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.
The initial prescription and renewal of the medication order beyond 7 days should be made by a physician only after appropriate examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining (see Warnings).
As with any antibiotic preparation, prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing. Appropriate measures should be taken if this occurs.
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 ophthalmic ointment.
All topically active corticosteroids possess the potential to suppress the pituitary-adrenal axis following systemic absorption. Development of adverse systemic effects due to the hydrocortisone component of ophthalmic ointment is considered to be unlikely, but the recommended dosage should not be exceeded.
Geriatrics: Cortisporin ophthalmic 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 ophthalmic ointment is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ophthalmic 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 ophthalmic 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 ophthalmic 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 ophthalmic 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%.
Ototoxicity and nephrotoxicity have been reported.
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensitivity to neomycin sulfate in certain selected groups of patients in dermatological practice, particularly those with 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.
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.
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.
The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea and ear are particularly prone to develop coincidentally with long-term application of steroids. 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.
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%.
Ototoxicity and nephrotoxicity have been reported.
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensitivity to neomycin sulfate in certain selected groups of patients in dermatological practice, particularly those with 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.
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.
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.
The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea and ear are particularly prone to develop coincidentally with long-term application of steroids. 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.
Overdose
Symptoms: No specific symptoms or signs have been associated with excessive use of Cortisporin ophthalmic ointment. However, consideration should be given to significant systemic absorption.
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 should be determined. Hemodialysis may reduce the serum level of neomycin sulfate.
Symptoms: No specific symptoms or signs have been associated with excessive use of Cortisporin ophthalmic ointment. However, consideration should be given to significant systemic absorption.
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 should be determined. Hemodialysis may reduce the serum level of neomycin sulfate.
Recommended Dosage
Treatment should not be continued for more than 7 days without medical supervision.
Adults: Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.
Children: Cortisporin ophthalmic ointment is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ophthalmic ointment is not recommended for use in neonates and infants (<2 years).
Geriatrics: Cortisporin ophthalmic 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 Contraindications, Warnings, and Precautions).
Use in Renal Impairment: Dosage should be reduced in patients with reduced renal function.
Treatment should not be continued for more than 7 days without medical supervision.
Adults: Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.
Children: Cortisporin ophthalmic ointment is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cortisporin ophthalmic ointment is not recommended for use in neonates and infants (<2 years).
Geriatrics: Cortisporin ophthalmic 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 Contraindications, Warnings, and Precautions).
Use in Renal Impairment: Dosage should be reduced in patients with reduced renal function.
Supplied / Packaging
Each g of ointment contains: polymyxin B sulfate 10000 units, bacitracin zinc 400 units, neomycin sulfate equivalent to 3.5mg neomycin base, and hydrocortisone 10 mg in a low melting point petrolatum base. Tubes of 3.5 g. Store between 15 and 25°C.
Each g of ointment contains: polymyxin B sulfate 10000 units, bacitracin zinc 400 units, neomycin sulfate equivalent to 3.5mg neomycin base, and hydrocortisone 10 mg in a low melting point petrolatum base. Tubes of 3.5 g. Store between 15 and 25°C.
Search for a drug
Brand Name
Cortisporin Ophthalmic Ointment
Cortisporin Ophthalmic Ointment
General Indications
Anti-inflammatory Antibacterial
Anti-inflammatory Antibacterial
