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Bacitracin (Topical)

Class: Antibacterials
VA Class: DE101
Molecular Formula: C66H103N17O16S
CAS Number: 1405-87-4

Medically reviewed by Drugs.com. Last updated on July 13, 2020.

Introduction

Polypeptide antibiotic.

Uses for Bacitracin (Topical)

Superficial Bacterial Skin Infections

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

Has been used alone or 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 other anti-infectives (i.e., polymyxin B and neomycin) and a corticosteroid (i.e., hydrocortisone) 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.

Bacitracin (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically to skin as an ointment, cream, or powder.

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. If using the powder, apply light dusting of powder to affected areas of skin.

May cover treated areas of skin with a sterile bandage.

Dosage

Pediatric Patients

Prevention of Superficial Bacterial Skin Infections
Topical

Children ≥2 years of age: Apply ointment 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.

Powder: Apply a light dusting on 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 (fixed combination of bacitracin, polymyxin B, neomycin, and hydrocortisone): Apply thin film to affected areas of skin 2–4 times daily for up to 7 days.

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.

Cautions for Bacitracin (Topical)

Contraindications

  • Sensitivity to bacitracin or any ingredient in the formulation.

  • Fixed combination of bacitracin, polymyxin B, neomycin, and hydrocortisone: 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 eyes or in external ear canal if eardrum is perforated.

Warnings/Precautions

Sensitivity Reactions

Minor skin irritation, rash, and allergic contact dermatitis or other hypersensitivity reactions have occurred.

More serious hypersensitivity reactions, including anaphylaxis, reported rarely following topical application to skin.

Topical anti-infectives, including bacitracin and neomycin, are known contact sensitizers.

Consider that patients allergic to bacitracin may have delayed cell-mediated contact dermatitis reactions or immediate IgE-mediated (e.g., 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.

Patients allergic to one fixed-combination topical preparation should avoid preparations containing any of the component drugs. Patients sensitive to bacitracin may also have cross-sensitivity to polymyxin B. In addition, patients allergic to fixed combinations containing neomycin may also be allergic to other aminoglycosides.

Other Warnings and Precautions

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

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

Use of Fixed Combinations

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

When fixed combinations containing neomycin used, consider that topical neomycin may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily rash) due to topical neomycin not known.

When fixed combination containing 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. Do not use fixed combination preparation containing hydrocortisone for >7 days; discontinue use and contact clinician if redness, irritation, swelling, or pain persists or increases.

Specific Populations

Pregnancy

Category C.

Some manufacturers advise pregnant patients to consult a clinician before using topical preparations containing bacitracin.

Fixed combination of bacitracin, polymyxin B, neomycin, and hydrocortisone: Use during pregnancy only if potential benefits justify potential risks to fetus. Topical corticosteroids are teratogenic in mice and rabbits.

Lactation

Not known whether topical bacitracin is distributed into milk.

Some experts consider topical bacitracin compatible with nursing.

Some manufacturers advise breast-feeding women to consult a clinician before using topical preparations containing bacitracin.

Fixed combination of bacitracin, polymyxin B, neomycin, and hydrocortisone: Use with caution in nursing women. Hydrocortisone is distributed into human milk following oral administration; systemic absorption may occur when hydrocortisone is applied topically.

Pediatric Use

Some manufacturers state do not use topical preparations containing bacitracin in children <2 years of age unless directed by a clinician.

Fixed combination of bacitracin, polymyxin B, neomycin, and hydrocortisone: Safety and efficacy not established in pediatric patients.

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.

Geriatric Use

Fixed combination of bacitracin, polymyxin B, neomycin, 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.

Common Adverse Effects

Minor skin irritation, rash, allergic contact dermatitis.

Bacitracin (Topical) Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from intact or denuded skin, wounds, or mucous membranes.

Stability

Storage

Topical

Cream

Fixed combination of bacitracin zinc, neomycin, polymyxin B, and local anesthetic (i.e., lidocaine): 15–30°C; protect from excessive heat and freezing.

Ointment

Bacitracin: 20–25°C.

Bacitracin zinc: 15–30°C; avoid exposure to excessive heat and humidity.

Fixed combinations of bacitracin zinc and polymyxin B with or without neomycin: 20–25 or 15–30°C, depending on manufacturer.

Fixed combination of bacitracin zinc, polymyxin B, neomycin, and hydrocortisone: 15–25°C.

Fixed combinations of bacitracin zinc and local anesthetic (i.e., lidocaine, pramoxine) with or without neomycin and polymyxin B: 15–30°C, depending on manufacturer; protect from excessive heat and freezing.

Powder

Fixed combination of bacitracin zinc and polymyxin B: 20–25°C; do not refrigerate.

Actions and Spectrum

  • Polypeptide antibiotic produced by Bacillus subtilis or B. licheniformis. Mixture of polypeptides (bacitracin A, B1, B2, and B3); major component is bacitracin A.

  • May be bactericidal or bacteriostatic depending on concentration of the drug at site of infection and susceptibility of infecting organism.

  • Inhibits bacterial cell wall synthesis by preventing incorporation of amino acids and nucleotides into the cell wall.

  • Active against some gram-positive aerobic bacteria (e.g., Staphylococcus aureus, Streptococcus pyogenes, Corynebacterium).

  • Active against some gram-negative aerobic bacteria (e.g., Haemophilus influenzae, Neisseria), but not active against most gram-negative bacilli.

  • Activity of bacitracin is not impaired by blood, pus, necrotic tissue, or large inocula.

  • Staphylococci (e.g., S. aureus) and streptococci resistant to bacitracin reported.

  • No cross-resistance between bacitracin and other anti-infectives.

Advice to Patients

  • Inform patients that topical preparations containing bacitracin 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 bacitracin for >1 week for prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns); importance of discontinuing use and consulting a clinician if condition persists or worsens.

  • Importance of discontinuing topical preparation containing bacitracin 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

Bacitracin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

500 units per g*

Bacitracin Ointment

Bacitraycin Plus Original

First Aid

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

Bacitracin Zinc

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

500 units (of bacitracin) per g*

Bacitracin Zinc Ointment

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

Bacitracin Zinc and Polymyxin B Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g*

Bacitracin Zinc and Polymyxin B Sulfate Ointment

Double Antibiotic Ointment

Fougera

Polysporin Ointment

Johnson & Johnson

Powder

Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g

Polysporin Powder

Johnson & Johnson

* 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

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

Other Bacitracin Zinc Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

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

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

Ointment

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

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

Bacitracin Zinc 500 units (of bacitracin) per g, 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*

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

Neosporin Plus

Johnson & Johnson

Triple Antibiotic Plus

Bacitracin Zinc 500 units (of bacitracin) per g and Pramoxine Hydrochloride 10 mg per g

Bacitracin Zinc and Pramoxine Hydrochloride Ointment

Bacitraycin Plus

First Aid

AHFS DI Essentials™. © Copyright 2021, 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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