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Neosporin Cream (Polymyxin B Sulfate Neomycin Sulfate Gramicidin)
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Pharmacology
The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Polymyxin B 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 . Bacitracin is active against most gram-positive bacteria, pathogenic Neisseria spp and H.influenzae . Gramicidin is active against most species of aerobic and anaerobic gram-positive bacteria.
The anti-infective components in the combination are included to provide action against specific organisms susceptible to them. Polymyxin B 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 . Bacitracin is active against most gram-positive bacteria, pathogenic Neisseria spp and H.influenzae . Gramicidin is active against most species of aerobic and anaerobic gram-positive bacteria.
Indications
The Anti-infective Components In The Combination Are Included To Provide Action Against Specific Organisms Susceptible To Them. Polymyxin B 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 . Bacitracin Is Active Against Most Gram-positive Bacteria, Pathogenic Neisseria Spp And H.influenzae . Gramicidin Is Active Against Most Species Of Aerobic And Anaerobic Gram-positive Bacteria.
The Anti-infective Components In The Combination Are Included To Provide Action Against Specific Organisms Susceptible To Them. Polymyxin B 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 . Bacitracin Is Active Against Most Gram-positive Bacteria, Pathogenic Neisseria Spp And H.influenzae . Gramicidin Is Active Against Most Species Of Aerobic And Anaerobic Gram-positive Bacteria.
Contraindications
General: The use of Neosporin 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.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Neosporin in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
A possibility of increased absorption exists in very young children, thus Neosporin is not recommended for use in neonates and infants (<2years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Cream: Neosporin cream should not be used in the eyes or in the external ear canal if the eardrum is perforated.
Ointment: Neosporin ointment should not be used in the eyes. It should not be used to treat otitis externa in the presence of a perforated tympanic membrane because of the risk of ototoxicity.
The presence of pre-existing nerve deafness is a contraindication to the use of Neosporin ointment or any topical aminoglycoside in circumstances where significant systemic absorption could occur.
Ophthalmic Ointment Sterile: Neosporin ophthalmic ointment sterile should not be used during surgical procedures or before surgery in circumstances where the product could gain access to intraocular fluids.
Eye and Ear Solution Sterile: For ophthalmic use, Neosporin Eye and Ear Solution Sterile should not be used during surgical procedures or before surgery in circumstances where the product could gain access to intraocular fluids.
For otic use, Neosporin eye and ear solution sterile is contraindicated in patients in whom perforation of the tympanic membrane is known or suspected and in long-standing cases of chronic otitis media, because of the possibility of ototoxicity caused by neomycin. In otic use, ototoxicity has been reported.
General: The use of Neosporin 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.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Neosporin in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
A possibility of increased absorption exists in very young children, thus Neosporin is not recommended for use in neonates and infants (<2years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Cream: Neosporin cream should not be used in the eyes or in the external ear canal if the eardrum is perforated.
Ointment: Neosporin ointment should not be used in the eyes. It should not be used to treat otitis externa in the presence of a perforated tympanic membrane because of the risk of ototoxicity.
The presence of pre-existing nerve deafness is a contraindication to the use of Neosporin ointment or any topical aminoglycoside in circumstances where significant systemic absorption could occur.
Ophthalmic Ointment Sterile: Neosporin ophthalmic ointment sterile should not be used during surgical procedures or before surgery in circumstances where the product could gain access to intraocular fluids.
Eye and Ear Solution Sterile: For ophthalmic use, Neosporin Eye and Ear Solution Sterile should not be used during surgical procedures or before surgery in circumstances where the product could gain access to intraocular fluids.
For otic use, Neosporin eye and ear solution sterile is contraindicated in patients in whom perforation of the tympanic membrane is known or suspected and in long-standing cases of chronic otitis media, because of the possibility of ototoxicity caused by neomycin. In otic use, ototoxicity has been reported.
Safety Information / Warning
General: 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.
Irrigating Solution: Prophylactic bladder care with Neosporin irrigating solution should not be given where there is a possibility of systemic absorption.
Neosporin irrigating solution is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters. Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces.
Neosporin irrigating solution should not be used for irrigation other than for the urinary bladder. Systemic absorption after topical administration of neomycin to open wounds, burns and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported.
Absorption of neomycin from the denuded bladder surface has been reported. However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neosporin irrigating solution is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10days (see Precautions).
When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive. In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration but also in terms of characteristics of the blocks produced.
General: 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.
Irrigating Solution: Prophylactic bladder care with Neosporin irrigating solution should not be given where there is a possibility of systemic absorption.
Neosporin irrigating solution is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters. Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces.
Neosporin irrigating solution should not be used for irrigation other than for the urinary bladder. Systemic absorption after topical administration of neomycin to open wounds, burns and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported.
Absorption of neomycin from the denuded bladder surface has been reported. However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neosporin irrigating solution is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10days (see Precautions).
When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive. In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration but also in terms of characteristics of the blocks produced.
Precautions
General: The use of Neosporin should not be continued for more than 7days without medical supervision. If the infection is not improved after 1week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed (see Warnings).
Articles in current medical literature indicate an increase in the incidence of allergies to neomycin in patients with stasis ulcers or eczema. The possibility of an allergic reaction to neomycin should be borne in mind.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
Because of the potential hazard of nephrotoxicity and ototoxicity due to neomycin, care should be exercised when treating extensive burns, trophic ulceration and other extensive conditions where absorption of neomycin is possible.
After a maximal course, treatment should not be repeated for at least 3 months.
Eye and Ear Solution: Neosporin eye and ear solution sterile should not be given subconjunctivally or intraocularly, nor should it be used for the irrigation of fistulous tracts in or about the eye or its socket. Treatment should be continued until at least 48hours after the eye has apparently recovered.
Irrigating Solution: Care should be taken to prevent reflux of Neosporin irrigating solution up to the ureters, since the concentration of neomycin may cause renal toxicity. Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if the components of the preparation are systemically absorbed (see Warnings). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of toxicity.
The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established.
Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive cultures suggest the presence of organisms which are resistant to the bladder rinse antibiotics.
Geriatrics: Neosporin 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: Neosporin 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 Neosporin is not recommended for use in neonates and infants (<2years) (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 Neosporin is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus, use of Neosporin 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 polymyxinB sulfate is unlikely to present a hazard during use of Neosporin.
General: The use of Neosporin should not be continued for more than 7days without medical supervision. If the infection is not improved after 1week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed (see Warnings).
Articles in current medical literature indicate an increase in the incidence of allergies to neomycin in patients with stasis ulcers or eczema. The possibility of an allergic reaction to neomycin should be borne in mind.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
Because of the potential hazard of nephrotoxicity and ototoxicity due to neomycin, care should be exercised when treating extensive burns, trophic ulceration and other extensive conditions where absorption of neomycin is possible.
After a maximal course, treatment should not be repeated for at least 3 months.
Eye and Ear Solution: Neosporin eye and ear solution sterile should not be given subconjunctivally or intraocularly, nor should it be used for the irrigation of fistulous tracts in or about the eye or its socket. Treatment should be continued until at least 48hours after the eye has apparently recovered.
Irrigating Solution: Care should be taken to prevent reflux of Neosporin irrigating solution up to the ureters, since the concentration of neomycin may cause renal toxicity. Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if the components of the preparation are systemically absorbed (see Warnings). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of toxicity.
The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established.
Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive cultures suggest the presence of organisms which are resistant to the bladder rinse antibiotics.
Geriatrics: Neosporin 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: Neosporin 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 Neosporin is not recommended for use in neonates and infants (<2years) (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 Neosporin is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus, use of Neosporin 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 polymyxinB sulfate is unlikely to present a hazard during use of Neosporin.
Side Effects / Adverse Effects
Adverse reactions have occurred with topical use of antibiotic combination containing neomycin and polymyxinB. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In 1clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in 2of 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 (see Warnings).
Stinging and burning have been reported rarely when this product has gained access to the middle ear.
The incidence of allergic hypersensitivity reactions to neomycin sulfate in the general population are low. 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 and polymyxin B sulfate are rare events.
Anaphylactic reactions following the topical application of bacitracin zinc have been reported, but are rare events.
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.
Irritation of the urinary bladder mucosa has been reported with use of Neosporin irrigating solution.
Adverse reactions have occurred with topical use of antibiotic combination containing neomycin and polymyxinB. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In 1clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in 2of 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 (see Warnings).
Stinging and burning have been reported rarely when this product has gained access to the middle ear.
The incidence of allergic hypersensitivity reactions to neomycin sulfate in the general population are low. 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 and polymyxin B sulfate are rare events.
Anaphylactic reactions following the topical application of bacitracin zinc have been reported, but are rare events.
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.
Irritation of the urinary bladder mucosa has been reported with use of Neosporin irrigating solution.
Overdose
Symptoms: No specific symptoms or signs have been associated with excessive use of Neosporin. However, consideration should be given to significant systemic absorption (see Contraindications, Warnings and Precautions).
Following accidental ingestion, minimal absorption is expected.
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, polymyxin B, and bacitracin zinc 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 Neosporin. However, consideration should be given to significant systemic absorption (see Contraindications, Warnings and Precautions).
Following accidental ingestion, minimal absorption is expected.
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, polymyxin B, and bacitracin zinc should be determined. Hemodialysis may reduce the serum level of neomycin sulfate.
Recommended Dosage
Treatment should not be continued for more than 7days without medical supervision.
Adults: Cream: Following any necessary removal of debris, such as pus, crusts, etc., from the affected area, apply a small quantity 2to 5times daily, as required. Rub in gently if condition permits.
Following any necessary removal of debris, such as pus, crusts, etc., from the affected area, apply a thin film 2to 5times daily over the affected area. Cover with dressing or leave exposed. Do not use in the eyes .
Treatment should not be continued for more than 7days without medical supervision.
Adults: Cream: Following any necessary removal of debris, such as pus, crusts, etc., from the affected area, apply a small quantity 2to 5times daily, as required. Rub in gently if condition permits.
Following any necessary removal of debris, such as pus, crusts, etc., from the affected area, apply a thin film 2to 5times daily over the affected area. Cover with dressing or leave exposed. Do not use in the eyes .
Supplied / Packaging
Neosporin formulations are antibacterial preparations for topical use. Only Neosporin ophthalmic ointment sterile and Neosporin eye and ear solution are sterile preparations appropriate for use in the eye.
Cream: Each g contains: polymyxinB sulfate 10000units, neomycin sulfate (equiv.to 3.5mg neomycin base) 5mg, gramicidin 250µg in a white vanishing cream base, pH approximately 5.0. Nonmedicinal ingredients: emulsifying wax, methylparaben, mineral oil, poloxamer, propylene glycol, purified water and white petrolatum. Tubes of15g. Store at 15to25°C.
Neosporin formulations are antibacterial preparations for topical use. Only Neosporin ophthalmic ointment sterile and Neosporin eye and ear solution are sterile preparations appropriate for use in the eye.
Cream: Each g contains: polymyxinB sulfate 10000units, neomycin sulfate (equiv.to 3.5mg neomycin base) 5mg, gramicidin 250µg in a white vanishing cream base, pH approximately 5.0. Nonmedicinal ingredients: emulsifying wax, methylparaben, mineral oil, poloxamer, propylene glycol, purified water and white petrolatum. Tubes of15g. Store at 15to25°C.
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Brand Name
Neosporin Cream
Neosporin Cream
Generic Name
Polymyxin B Sulfate Neomycin Sulfate Gramicidin
Polymyxin B Sulfate Neomycin Sulfate Gramicidin
General Indications
Antibacterial
Antibacterial
