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Neomycin (Topical)

Class: Antibacterials
VA Class: DE101
CAS Number: 1405-10-3

Medically reviewed by Drugs.com on Jul 13, 2020. Written by ASHP.

Introduction

Aminoglycoside antibiotic.

Uses for Neomycin (Topical)

Superficial Bacterial Skin Infections

Used topically in fixed combination with other anti-infectives (i.e., polymyxin B with or without bacitracin) for prevention of superficial bacterial skin infections associated with minor cuts, scrapes, or burns.

Has been used in fixed combination with other anti-infectives for topical treatment of minor skin infections caused by susceptible bacteria. Role, if any, of topical anti-infectives for treatment of superficial skin infections not fully elucidated.

Self-medication with topical anti-infectives for prevention or treatment of superficial skin infections not usually recommended.

Infected Corticosteroid-responsive Dermatoses

Used topically in fixed combination with a corticosteroid (i.e., fluocinolone, hydrocortisone) with or without other anti-infectives (i.e., polymyxin B with or without bacitracin) for treatment of corticosteroid-responsive dermatoses with secondary infection.

No evidence that fixed-combination topical preparations that include anti-infectives and a corticosteroid provide greater benefit than use of a topical corticosteroid alone after 7 days of treatment. Weigh possible benefits of fixed-combination topical preparation containing anti-infectives and a corticosteroid against risk that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.

Prevention of Bacteriuria Associated with Indwelling Catheters

Fixed combination of neomycin and polymyxin B used for short-term (≤10 days) continuous irrigation of the urinary bladder in abacteriuric patients for prevention of bacteriuria and gram-negative septicemia associated with use of indwelling catheters.

Routine bladder irrigation with anti-infectives not recommended to prevent or eradicate catheter-associated bacteriuria in patients with indwelling catheters; use of neomycin solutions for bladder irrigation no longer recommended.

Instillation/Irrigation

Has been used in the past for peritoneal instillation and for irrigation of wounds or surgical sites; no longer recommended for these uses because severe toxicity (e.g., ototoxicity) may occur.

Neomycin (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically to skin as an ointment or cream.

For external use only on skin; do not use in the eyes.

Do not apply to extensive areas of skin, deep or puncture wounds, animal bites, or serious burns.

Apply small amount of topical ointment or cream (amount equal to surface area of fingertip) to cleansed, affected areas of skin.

May cover affected areas with a sterile bandage. However, at least one manufacturer of a topical preparation containing neomycin and a corticosteroid (i.e., fluocinolone) states do not use bandages or occlusive coverings on treated areas of skin unless directed by a clinician.

Bladder Irrigation

Commercially available irrigation solution concentrate containing fixed combination of neomycin and polymyxin B is for continuous irrigation of the intact urinary bladder only; do not use for irrigation at any other site and do not administer by injection or any other route.

The irrigation solution concentrate must be diluted prior to use.

Administer diluted irrigation solution by continuous bladder irrigation via a 3-way catheter; do not interrupt inflow of the diluted solution for more than a few minutes.

Dilution

Add contents of 1-mL ampul of commercially available irrigation solution concentrate (40 mg of neomycin and 200,000 units of polymyxin B sulfate) to 1 L of 0.9% sodium chloride solution.

Rate of Administration

Administer diluted irrigation solution by continuous bladder irrigation using inflow rate of 1 L every 24 hours. Adjust inflow rate to 2 L every 24 hours if patient’s urine output exceeds 2 L daily.

Dosage

Available as neomycin sulfate; dosage usually expressed in terms of the base.

Pediatric Patients

Prevention of Superficial Bacterial Skin Infections
Topical

Children ≥2 years of age: Apply ointment or cream to affected areas of skin 1–3 times daily.

May use for up to 1 week for self-medication. Discontinue use and contact a clinician if condition persists for >1 week or worsens.

Adults

Prevention of Superficial Bacterial Skin Infections
Topical

Ointment or cream: Apply to affected areas of skin 1–3 times daily.

May use for up to 1 week for self-medication. Discontinue use and contact a clinician if condition persists for >1 week or worsens.

Infected Corticosteroid-responsive Dermatoses
Topical

Ointment or cream (fixed combination of neomycin and a corticosteroid with or without other anti-infectives): Apply thin film to affected areas of skin 2–4 times daily for up to 7 days.

Prevention of Bacteriuria Associated with Indwelling Catheters
Bladder Irrigation

1 L of diluted irrigation solution (40 mg of neomycin and 200,000 units of polymyxin B sulfate in 0.9% sodium chloride solution) by continuous bladder irrigation every 24 hours for up to 10 days. (See Bladder Irrigation under Dosage and Administration.)

Prescribing Limits

Pediatric Patients

Prevention of Superficial Bacterial Skin Infections
Topical

Maximum duration: 1 week, unless directed by a clinician.

Adults

Prevention of Superficial Bacterial Skin Infections
Topical

Maximum duration: 1 week, unless directed by a clinician.

Infected Corticosteroid-responsive Dermatoses
Topical

Maximum duration: 7 days.

Prevention of Bacteriuria Associated with Indwelling Catheters
Bladder Irrigation

Maximum duration: 10 days.

Cautions for Neomycin (Topical)

Contraindications

  • Topical (fixed combinations of neomycin and other anti-infectives with or without a topical anesthetic): Hypersensitivity to neomycin or any ingredient in the formulation.

  • Topical (fixed combinations of neomycin and a corticosteroid with or without other anti-infectives): Hypersensitivity to any ingredient in the formulation or presence of tuberculous, fungal, or viral (e.g., herpes simplex, varicella zoster) skin lesions. Also contraindicated for use in the eyes or in external ear canal if eardrum is perforated.

  • Bladder irrigation (fixed combination of neomycin and polymyxin B): Hypersensitivity to neomycin, polymyxins, or any ingredient in the formulation. Because of cross-sensitivity among aminoglycosides, may also be contraindicated in those with history of hypersensitivity or serious toxic reaction to any aminoglycoside.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions, including contact dermatitis, burning, erythema, rash, and urticaria, reported following topical application of neomycin in patients sensitive to the drug or other ingredients in the formulation. Anaphylactoid reactions reported rarely with topical application of neomycin.

Topical neomycin is a contact sensitizer, especially when used for prolonged periods.

Consider that patients allergic to neomycin may have cutaneous sensitivity reactions or anaphylactic reactions to the drug.

If itching, burning, rash, or any other signs of sensitivity or allergic reaction occur, discontinue use and consult a clinician.

Cross-allergenicity occurs among the aminoglycosides; consider that patients sensitive to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides.

Patients allergic to one fixed-combination topical preparation containing neomycin should avoid preparations containing any of the component drugs.

Other Warnings and Precautions

Precautions Related to Topical Use

Do not use for >1 week unless directed by a clinician.

Prolonged use may promote bacterial resistance and should be avoided. Overgrowth of nonsusceptible organisms, including fungi, may occur.

Ototoxicity, nephrotoxicity, and neuromuscular blockade reported following topical application of neomycin resulting in systemic absorption of the drug, especially when used for peritoneal instillation, irrigation of wounds or surgical sites, or topical treatment for skin ulcers, granulating wounds, serious burns, or extensive areas of denuded skin. Death reported rarely.

Because of risk of systemic absorption and possibility of toxicity (ototoxicity, nephrotoxicity, neuromuscular blockade), use with caution for topical treatment of extensive burns, trophic ulceration, or other extensive dermatologic conditions where rapid absorption of the drug is possible. Apply topical neomycin no more than once daily in treatment of patients with burns covering ≥20% of their body surface area, especially if patient has impaired renal function or is receiving other aminoglycosides concurrently.

Precautions Related to Bladder Irrigation

Do not use irrigation solution containing fixed combination of neomycin and polymyxin B if there is a possibility of systemic absorption. The irrigation solution is intended for continuous prophylactic bladder irrigation only in patients with an intact urinary bladder. Because of risk of systemic absorption and toxicity (e.g., ototoxicity, nephrotoxicity, neuromuscular blockade), avoid use in patients with defects in bladder mucosa or bladder wall (e.g., vesical rupture) and do not use in conjunction with operative procedures involving bladder wall. Patients with impaired renal function, infants, dehydrated patients, geriatric patients, and those receiving prolonged treatment with high doses are especially at risk for toxicity.

Safety and efficacy of bladder irrigation with the fixed combination solution not established in patients with recent lower urinary tract surgery.

Bladder irrigation may result in overgrowth of nonsusceptible organisms, including fungi; take appropriate measures as needed.

Collect urine specimens for urinalysis, culture, and susceptibility testing. If uropathogens isolated, perform in vitro susceptibility testing and initiate systemic anti-infective therapy if appropriate.

Use of Fixed Combinations

When used in fixed combination with other topical anti-infectives (i.e., polymyxin B with or without bacitracin), topical corticosteroids (i.e., fluocinolone, hydrocortisone), or topical anesthetics (i.e., lidocaine, pramoxine), consider cautions, precautions, and contraindications associated with each drug in the fixed combination.

When fixed combination containing a corticosteroid (i.e., fluocinolone, hydrocortisone) used, consider that topical corticosteroids used in fixed combination with topical anti-infectives may mask clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the anti-infectives or other ingredients in the formulation. Also consider that use of topical corticosteroids can result in signs and symptoms of exogenous hyperadrenocorticism, including adrenal suppression, and that systemic absorption of topically applied corticosteroids is increased if extensive body surface areas treated or if occlusive dressing used. Discontinue use if redness, irritation, swelling, or pain persists or increases.

Specific Populations

Pregnancy

Aminoglycosides may cause fetal harm following systemic absorption in pregnant women. The drugs cross the placenta; total, irreversible, bilateral, congenital deafness reported in some children whose mothers received parenteral streptomycin during pregnancy.

Topical (neomycin in fixed combination with other anti-infectives): Category C.

Topical (fixed combination of neomycin and a corticosteroid with or without other anti-infectives): Use during pregnancy only if potential benefits justify potential risks to fetus. Topical corticosteroids have been teratogenic in animals (mice, rabbits).

Bladder irrigation (fixed combination of neomycin and polymyxin B): If used during pregnancy, inform patient about potential hazard to the fetus.

Lactation

Clinically unimportant amounts of neomycin may distribute into breast milk following systemic absorption.

Topical (fixed combination of neomycin and a corticosteroid with or without other anti-infectives): Use with caution in nursing women. Systemic corticosteroids (e.g., oral) are distributed into human milk; systemic absorption may occur when corticosteroids are applied topically.

Pediatric Use

Topical: Some manufacturers state do not use in children ≤2 years of age unless directed by a clinician.

Topical (fixed combination of neomycin and fluocinolone): Manufacturer states use least amount compatible with an effective therapy regimen; pediatric patients may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than more mature patients because of a larger skin surface area to body weight ratio.

Topical (fixed combination of neomycin, polymyxin B with or without bacitracin, and hydrocortisone): Safety and efficacy not established in pediatric patients. If topical hydrocortisone used for prolonged periods in infants and children, sufficient percutaneous absorption of the drug can occur and cause cessation of growth, as well as other signs and symptoms of hyperadrenocorticism.

Topical (fixed combination of neomycin, polymyxin B, bacitracin, and lidocaine): At least one manufacturer states do not use in children <12 years of age unless directed by a clinician.

Bladder irrigation (fixed combination of neomycin and polymyxin B): Safety and efficacy not established in pediatric patients.

Geriatric Use

Topical (fixed combination of neomycin, polymyxin B with or without bacitracin, and hydrocortisone): Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric individuals respond differently than younger patients; other reported clinical experience has not identified differences in responses between geriatric and younger patients.

Bladder irrigation (fixed combination of neomycin and polymyxin B): Increased risk of toxicity in geriatric patients receiving prolonged treatment with high doses.

Renal Impairment

Bladder irrigation (fixed combination of neomycin and polymyxin B): Risk of toxicity increased in patients with renal impairment.

Common Adverse Effects

Topical: Allergic contact dermatitis.

Bladder irrigation: Irritation of urinary bladder mucosa.

Neomycin (Topical) Pharmacokinetics

Absorption

Bioavailability

Topical: Not absorbed to any appreciable extent from intact skin. Readily absorbed through denuded or abraded areas of skin or skin that has lost the keratin layer (i.e., wounds, burns, ulcers).

Bladder irrigation: Systemic absorption not expected to be clinically important if bladder is intact and duration of irrigation is ≤10 days. Systemic absorption may occur if bladder surface is denuded or inflamed.

Rapidly absorbed from the peritoneum, draining sinuses, wounds, or surgical sites.

Plasma Concentrations

Plasma concentrations following topical application to open wounds, burns, or granulating surfaces comparable to, or higher than, those achieved following oral or parenteral administration (parenteral preparation no longer available in US).

Stability

Storage

Topical

Ointments and Creams

20–25 or 15–30°C, depending on manufacturer.

Some manufacturers state protect from excessive heat and freezing.

Bladder Irrigation

Solution Concentrate for Irrigation

2–8°C.

Following dilution in 0.9% sodium chloride, store at 4°C and use within 48 hours after dilution.

Actions and Spectrum

  • Usually bactericidal.

  • Appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.

  • Spectrum of activity includes some aerobic gram-positive bacteria and many aerobic gram-negative bacteria.

  • Gram-positive aerobes: Active against Staphylococcus aureus and S. epidermidis. Most streptococci are resistant.

  • Gram-negative aerobes: Active against Escherichia coli, Haemophilus influenzae, Klebsiella, Neisseria, Moraxella lacinate, and Proteus. Inactive against Serratia and Pseudomonas aeruginosa.

Advice to Patients

  • Inform patients that topical preparations containing neomycin are for external use only; do not use in the eyes and do not apply over large areas of the body.

  • For self-medication, importance of not using topical preparations containing neomycin for >1 week for prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) unless directed by a clinician; importance of discontinuing use and consulting clinician if condition persists or worsens.

  • Importance of discontinuing topical preparation containing neomycin and consulting a clinician if itching, burning, rash or any other signs of sensitivity or allergic reaction occur.

  • Importance of first consulting a clinician if considering use for self-medication for deep or puncture wounds, animal bites, or serious burns.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Urogenital

For irrigation, concentrate

Neosporin Sulfate 40 mg (of neomycin) per mL and Polymyxin B Sulfate 200,000 units per mL*

Neomycin and Polymyxin B Sulfates Solution for Irrigation

Neosporin G.U. Irrigant

Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g*

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment

Neosporin Original

Johnson & Johnson

Triple Antibiotic Ointment

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%

Cortisporin Ointment

Pfizer

Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Hydrocortisone Acetate 5 mg per g

Cortisporin Cream

Pfizer

Neomycin Sulfate and Fluocinolone Acetonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

Neomycin Sulfate 3.5 mg (of neomycin) per g and Fluocinolone Acetonide 0.25 mg per g

Neo-Synalar

Medimetriks

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Neomycin Sulfate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Lidocaine Hydrochloride 20 mg per g*

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Lidocaine Hydrochloride Cream

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Pramoxine Hydrochloride 10 mg per g*

Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride Cream

Ointment

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units per g, Bacitracin Zinc 400 units per g, and Lidocaine 40 mg per g*

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Lidocaine Ointment

Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 500 units (of bacitracin) per g, and Pramoxine Hydrochloride 10 mg per g*

Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, and Pramoxine Hydrochloride Ointment

Triple Antibiotic Plus

Neosporin Plus

Johnson & Johnson

AHFS DI Essentials™. © Copyright 2022, Selected Revisions July 13, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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