Bacitracin Zinc eent

Pronunciation

Class: Antibacterials
VA Class: DE101
CAS Number: 1405-87-4
Brands: AK-Poly-Bac

Introduction

Antibacterial; polypeptide antibiotic produced by Bacillus subtilis.104 a d e f

Uses for Bacitracin Zinc

Bacterial Ophthalmic Infections

Treatment of superficial infections of the eye involving the conjunctiva and/or cornea caused by susceptible organisms.101 d e

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Used alone or in fixed combination with other topical anti-infectives (e.g., neomycin, polymyxin B) with or without topical corticosteroids (e.g., hydrocortisone) when such combination therapy is indicated.104 a d e f (See Use of Fixed Combinations under Cautions.)

Not recommended for topical prophylaxis of neonatal ophthalmia.a

Not indicated for treatment of deep-seated ocular infections or infections likely to become systemic.101

Bacitracin Zinc Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to conjunctival sac of the eye as an ointment.101

Not for injection into the eye; do not instill directly into the anterior chamber of the eye.104 e f

When treating blepharitis, carefully remove all scales and crusts prior to application of the ointment; spread ointment uniformly over lid margins.101

Avoid contaminating the tip of the ointment container.101 104 e f

Dosage

Available as bacitracin alone; as fixed combination containing bacitracin zinc and polymyxin B sulfate; and as fixed combinations containing bacitracin zinc, and neomycin and polymyxin B sulfates, with or without hydrocortisone or hydrocortisone acetate. Dosage of bacitracin or bacitracin zinc is expressed in terms of bacitracin.101 104 d e f

Adults

Bacterial Ophthalmic Infections
Bacitracin
Ophthalmic Ointment

Apply into the conjunctival sac of the affected eye(s) 1–3 times daily.101

Bacitracin Zinc and Neomycin and Polymyxin B Sulfates
Ophthalmic Ointment

Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.e

Bacitracin Zinc, Neomycin and Polymyxin B Sulfates, and Hydrocortisone
Ophthalmic Ointment

Apply to affected eye(s) every 3 or 4 hours, depending on severity of the condition.104 f

Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment

Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on the severity of the infection.d

Special Populations

No special population dosing recommendations at this time.101 104 a d e f

Cautions for Bacitracin Zinc

Contraindications

  • Known hypersensitivity to bacitracin or any ingredient in the formulation.101 104 a d e f

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Cutaneous sensitization possible (e.g., itching, reddening, conjunctival or eyelid edema).104 e

Hypersensitivity reactions (e.g., itching, rash, swelling of lips and face, sweating, tightness of the chest), including anaphylaxis, reported rarely.a

During long-term use of topical antibiotics, periodically examine patient for signs of sensitization; may manifest as a failure to heal.104 e f If signs or symptoms of sensitivity occur, discontinue the drug.101 104 a e f

Patients sensitive to neomycin may also be sensitive to bacitracin.a

General Precautions

Deep-seated Ocular Infections

Do not use for treatment of deep-seated ocular infections or infections likely to become systemic.101

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.101 104 d e f Discontinue drug and institute appropriate therapy if superinfection occurs.101 a d e

Infection Complications

Ophthalmic ointments may delay healing.104 d e f

Use of Fixed Combinations

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections, prevent recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to bacitracin or other ingredients in the formulation.f

When bacitracin is used in fixed combination with other agents (corticosteroids, other anti-infectives), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).104 d e f

Specific Populations

Pregnancy

Category C.104 e f

Lactation

Experts consider topical bacitracin compatible with nursing.g

Use the fixed combination with neomycin and polymyxin B sulfates with caution in nursing women.e

Pediatric Use

Safety and efficacy not established in pediatric patients.104 e f

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.104 e

Bacitracin Zinc Pharmacokinetics

Absorption

Extent

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

Distribution

Extent

Not known whether topical bacitracin is distributed into breast milk.e g

Stability

Storage

Ophthalmic

Ointment

Bacitracin: 15–30°C.a

Bacitracin zinc and polymyxin B sulfate: 20–25°C.d

Neomycin and polymyxin B sulfates and bacitracin zinc: 20–25°C.e

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone: 15–30°C.f

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate: 15–25°C.104

Actions and Spectrum

  • Bacitracin consists of 3 separate compounds, bacitracin A, B, and C; bacitracin A is the chief constituent.a d e

  • May be bactericidal or bacteriostatic in action, depending on concentration of the drug attained at the site of infection and the susceptibility of the infecting organism.a e

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

  • Spectrum of activity includes many gram-positive aerobic bacteria, some aerobic gram-negative bacteria, and some anaerobic bacteria.a 101 e Inactive against fungi.101

  • Gram-positive bacteria: Active against Staphylococcus aureus and some streptococci.a 101

  • An increasing number of staphylococci, including penicillin-resistant staphylococci, are resistant to bacitracin.a Cross-resistance does not usually occur between bacitracin and other anti-infectives.a

Advice to Patients

  • Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.101 104 e f Advise patient to keep container tightly closed when not in use.e f

  • Importance of discontinuing therapy and contacting clinician if the infection worsens or does not improve, or if any signs of sensitivity occur (e.g., rash, itching, swelling, redness, burning).101 104 a e f

  • Advise patient not to share the drug with any other person.104 e

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.104 d e

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.104 e

  • 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.

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

Bacitracin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

500 units/g*

Bacitracin

Akorn, Fougera

Bacitracin Zinc and Polymyxin B Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

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

AK-Poly-Bac

Akorn

Bacitracin Zinc and Polymyxin B Sulfate

Bausch & Lomb, Fougera

* 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

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g*

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Bausch & Lomb, Fougera

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

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%*

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Bausch & Lomb

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1%

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate

Fougera

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

101. E. Fougera & Co. Bacitracin ophthalmic ointment USP prescribing information. Melville, NY; 1998 Mar.

102. Akorn. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment USP prescribing information. Buffalo Grove, IL; 2003 Dec.

103. Akorn. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Somerset, NJ; 1998 Jul.

104. E. Fougera & Co. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY; 2004 Aug.

a. AHFS drug information 2008. McEvoy, GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2837-8.

d. Akorn, Inc. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Buffalo Grove, IL; 2007 Aug.

e. Akorn, Inc. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP prescribing information. Buffalo Grove, IL; 2007 Oct.

f. Bausch & Lomb Incorporated. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment USP prescribing information. Tampa, FL; 2003 Nov.

g. Briggs CC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation, 7th ed. Philadelphia, PA: Lippincott, Williams, & Wilkins; 2005: 144-5.

h. AHFS drug information 2008. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2867-9.

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