Wednesday, September 14, 2016

Bacitracin topical



Class: Antibacterials
VA Class: DE101
CAS Number: 1405-87-4
Brands: Baciguent, Baci-Rx, Bactine First Aid Antibiotic Plus Anesthetic, Band-Aid with Antibiotic, Betadine Brand First Aid Antibiotics + Moisturizer, Betadine Brand First Aid Antibiotics + Pain Reliever, Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength, Double Antibiotic, Mycitracin Plus Pain Reliever, Neosporin, Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving, Polysporin, Spectrocin Plus, Triple Antibiotic, Triple Antibiotic Extra, Zeba-Rx

Introduction

Polypeptide antibiotic.


Uses for Bacitracin


Superficial Skin Infections


Topically (alone or in combination with other anti-infectives) to prevent or treat superficial skin infections caused by susceptible organisms.a


May be useful for preventing infection in minor skin injuries (e.g., cuts, scrapes, burns).a


Role of topical anti-infectives for treatment of superficial skin infections has not been fully elucidated.a


Self-medication with topical anti-infectives to treat superficial skin infections currently is not recommended.a


Treatment of serious or extensive skin infections usually requires systemic anti-infective therapy.a


Bacitracin Dosage and Administration


Administration


Apply ointment or powder topically to cleansed area.a


May cover affected area with a sterile bandage following use of ointments, powders, or sprays.a


Has been used for topical compresses in 0.9% sodium chloride injection or sterile water for injection (250–1000 units/mL).a


Dosage


Adults


Superficial Skin Infections

Topical

Ointment: Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.a


Powder: Use a light dusting on affected area 1–3 times daily.a


Prescribing Limits


Maximum 1 week of use unless directed by a physician.a


Cautions for Bacitracin


Contraindications



  • Known history of hypersensitivity to bacitracin or any ingredients in the formulations.a




  • Avoid use in atopic individuals.a



Warnings/Precautions


Sensitivity Reactions


Rashes and allergic anaphylactoid reactions have occurred, but topical application has low order of toxicity.a


If itching, burning, inflammation, or other signs of sensitivity occur, discontinue use and consult a clinician.a


Sensitivity to neomycin also may indicate sensitivity to bacitracin.a


Patch testing (e.g., 1% bacitracin in petrolatum) may be useful in diagnosing suspected allergic contact dermatitis when hypersensitivity to other topical antibiotics (e.g., neomycin) is suspected.a


General Precautions


Overgrowth of nonsusceptible organisms, particularly Candida, may occur; institute appropriate therapy if superinfection occurs.a


Topical use of bacitracin should not replace appropriate surgical management or other measures.a


Consider systemic anti-infective therapy if a deep-seated infection is present.a


Corticosteroids in topical anti-infective combination preparations may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotics or other ingredients in the formulations; weigh benefits against risks.a


Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.


Specific Populations


Pregnancy

Category C.b


Lactation

Not known whether topical bacitracin is distributed into milk.b


Bacitracin Pharmacokinetics


Absorption


Bioavailability


Not absorbed to any appreciable extent from intact or denuded skin, wounds, or mucous membranes.a


Stability


Storage


Topical


Ointment

15–30°C.a


Powder

2–15°C; protect from direct sunlight.a


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Topical










Vehicle Compatibility

Compatiblea



Lanolin



Paraffins



Petrolatum



White wax



Incompatible



Water-miscible bases











Mixture Compatibility

Incompatiblea



Benzalkonium chloride



Benzoates



Cetylpyridinium chloride



Heavy metal salts



Salicylates



Sodium lauryl sulfate



Tannates


Actions and SpectrumActions



  • Polypeptide antibiotic produced by Bacillus subtilis; consists of 3 separate compounds, bacitracin A (chief constituent), B, and C.a




  • Bactericidal or bacteriostatic, depending on concentration attained at infection site and infecting organism's susceptibility.a




  • Inhibits bacterial cell-wall synthesis, damages the bacterial plasma membrane and is active against protoplasts.a




  • Active against many gram-positive organisms such as staphylococci (including some penicillin-resistant staphylococci), streptococci, anaerobic cocci, corynebacteria, and clostridia; in vitro, bacitracin 0.05–5 mcg/mL inhibits most susceptible strains of Staphylococcus aureus.a




  • Active against gonococci, meningococci, and fusobacteria, but not most other gram-negative organisms.a




  • Also active against Actinomyces israelii, Treponema pallidum, and T. vincenti.a




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




  • In susceptible bacteria, bacitracin resistance seldom occurs; if it does occur, it emerges slowly.a




  • Staphylococci, including penicillin-resistant staphylococci, are increasingly becoming resistant.a




  • No cross-resistance with other antibiotics.a



Advice to Patients



  • Importance of discontinuing bacitracin and consulting a clinician if itching, burning, inflammation, or other signs of sensitivity occur.a




  • Importance of understanding that topical bacitracin preparations are intended for external use only.a




  • Importance of not using in the eyes or applying over large areas of the body.




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




  • Importance of discontinuing use and consulting a clinician if condition persists or worsens when used to prevent infection in minor skin injuries (e.g., cuts, scrapes, burns).a




  • Importance of not using for >1 week unless directed by a clinician.a




  • 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.a (See Cautions.)



Preparations


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


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


















Bacitracin

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder*



Topical



Ointment



500 units/g*



Baciguent



Lee Pharmaceuticals


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













Bacitracin Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Ointment



400 units/g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 5000 units (of polymyxin B) per g*



Triple Antibiotic Ointment



Alpharma, Pfeiffer


















Bacitracin Zinc

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder



Topical



Ointment



500 units (of bacitracin) per g



Bacitracin Zinc Ointment



Alpharma, Rugby


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


































































































Bacitracin Zinc Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Ointment



400 units (of bacitracin) per g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 5000 units (of polymyxin B) per g



Neosporin



Pfizer



Triple Antibiotic Ointment



500 units (of bacitracin) per g with Lidocaine 4%, Neomycin Sulfate 0.5% (0.35% of neomycin), and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g*



Bactine First Aid Antibiotic Plus Anesthetic



Bayer



Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength



Bayer



Mycitracin Plus Pain Reliever (with parabens)



J&J Consumer



Spectrocin Plus



Numark



Triple Antibiotic Extra



IVAX



Triple Antibiotic Plus Ointment Maximum Strength



Alpharma, G&W, Major



Triple Antibiotic with Lidocaine Ointment Maximum Strength



Clay-Park, Moore



500 units (of bacitracin) per g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g



Mycitracin Triple Antibiotic First Aid Ointment Maximum Strength (with parabens)



J&J Consumer



500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g and Pramoxine Hydrochloride 1%



Betadine Brand First Aid Antibiotics + Pain Reliever



Purdue Frederick



500 units (of bacitracin) per g, with Neomycin Sulfate 0.5% (0.35% of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Pramoxine Hydrochloride 1%



Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving Ointment



Pfizer



500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g



Bacitracin-Polymyxin Ointment



Clay-Park, Major, Rugby



Band-Aid with Antibiotic Ointment



J&J Consumer



Betadine Brand First Aid Antibiotics + Moisturizer Ointment



Purdue Frederick



Double Antibiotic Ointment



Fougera



Polysporin Ointment



Pfizer



Powder



500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g



Polysporin Powder



Pfizer


Anti-infective combinations including bacitracin are also commercially available in combination with corticosteroids for topical use.



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. AHFS drug information 2004. McEvoy GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2004:3305-6.



b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002: 120/b.



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