Introduction

Antibacterial; polypeptide antibiotic.

Uses for Bacitracin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of superficial infections of the eye involving the conjunctiva and/or cornea caused by susceptible bacteria.

Used in fixed combination with polymyxin B with or without neomycin for topical treatment of superficial infections of the eye involving the conjunctiva and/or cornea (e.g., conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis) caused by susceptible bacteria.

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment. Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications, avoid indiscriminate use of topical anti-infectives. Treatment of acute bacterial conjunctivitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. In vitro staining and/or cultures of conjunctival material may be indicated in management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Because bacterial keratitis may be associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in corneal perforation with potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up. Treatment of community-acquired bacterial keratitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent. In vitro staining and/or cultures of corneal material are indicated in management of keratitis involving corneal infiltrates that are central, large, and extend to the middle to deep stroma; when keratitis is chronic or unresponsive to broad-spectrum topical anti-infective treatment; or when atypical features suggest fungal, amebic, or mycobacterial infection.

Ocular Inflammation

Fixed-combination ophthalmic preparations containing bacitracin, neomycin, polymyxin B, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are used for topical treatment of corticosteroid-responsive ocular conditions when a corticosteroid is indicated and superficial bacterial ocular infection or risk of such infection exists.

Although manufacturers state that use of fixed-combination ophthalmic preparations containing anti-infectives and a corticosteroid may be indicated in ocular inflammatory conditions when risk of superficial ocular infection is high or when potentially dangerous numbers of bacteria are expected to be present in the eye, experts state avoid use of such preparations in patients with bacterial conjunctivitis because of risk of potentiating the infection.

Consider that fixed-combination ophthalmic preparations containing anti-infectives and a corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infectives; and/or increase IOP. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Bacitracin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply topically into conjunctival sac of the eye as an ointment.

For topical ophthalmic use only; do not inject directly into anterior chamber of the eye.

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

Avoid contaminating container tip with material from eye, eyelid, or any other source.

Dosage

Dosage of bacitracin or bacitracin zinc expressed in terms of bacitracin.

Adults

Bacterial Ophthalmic Infections

Ophthalmic

Bacitracin (ophthalmic ointment): Apply to affected eye(s) 1–3 times daily.

Bacitracin and polymyxin B (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.

Bacitracin, neomycin, and polymyxin B (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; 5–7 days usually adequate for mild bacterial conjunctivitis.

Ocular Inflammation

Ophthalmic

Bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours, depending on severity of the condition.

If no improvement after 48 hours, reevaluate patient. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Special Populations

No special population dosing recommendations.

Contraindications

• Known hypersensitivity to bacitracin or any ingredient in the formulation.

• Fixed combinations of bacitracin and polymyxin B with or without neomycin: Hypersensitivity to any ingredient in the formulation.

• Fixed combinations of bacitracin, neomycin, polymyxin B, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate): Known or suspected hypersensitivity to any ingredient in the formulation. Also, viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial infections of the eye, or fungal diseases of ocular structures.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Local irritation and allergic reactions reported (e.g., pruritus, reddening, conjunctival or eyelid edema); more serious hypersensitivity reactions, including anaphylaxis, reported rarely.

Topical anti-infectives, particularly neomycin, may cause cutaneous sensitization.

During long-term use, periodically examine patient for signs of sensitization (e.g., rash, pruritus, edema of the conjunctiva and eyelid, conjunctival erythema); may manifest as failure to heal.

If signs or symptoms of sensitivity occur, discontinue the drug. Symptoms usually subside quickly after ophthalmic preparation discontinued.

Patients allergic to one fixed-combination ophthalmic preparation should avoid preparations containing any of the component drugs. In addition, patients allergic to fixed combinations containing neomycin may also be allergic to other aminoglycoside (e.g., gentamicin, paromomycin, streptomycin).

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Initiate appropriate therapy if superinfection occurs.

Resistance to bacitracin or other anti-infectives in fixed-combination preparations (i.e., polymyxin B, neomycin) may develop.

Precautions Related to Ophthalmic Administration

Bacterial keratitis has developed in patients who inadvertently contaminated the multiple-dose container of their ophthalmic preparation; in most reported cases, concurrent corneal disease or disruption of ocular epithelial surface was present.

Manufacturers caution that ophthalmic ointments may delay healing.

Use of Fixed Combinations Containing Corticosteroids

When ophthalmic preparations containing bacitracin, neomycin, and polymyxin B in fixed combination with a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are used, consider cautions, precautions, and contraindications associated with EENT corticosteroids.

Provide initial prescriptions for fixed-combination ophthalmic preparations containing a corticosteroid or renewal prescriptions (beyond 8 g of ophthalmic ointment) only after examining patient with slit lamp microscopy and, when appropriate, fluorescein staining.

Reevaluate patient if inflammation or pain persists for >48 hours or becomes aggravated.

Prolonged use of ophthalmic preparations containing a corticosteroid may result in glaucoma, with optic nerve damage, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. If used for ≥10 days, monitor IOP regularly, even though monitoring may be difficult in children and uncooperative patients. Use with caution in patients with glaucoma; check IOP frequently in such patients.

Use after cataract surgery may delay healing and increase incidence of bleb formation.

Corneal and scleral thinning reported with various ocular diseases and with long-term use of topical ophthalmic corticosteroids. Use in patients with thin corneal and scleral tissue may result in perforation.

Prolonged use may suppress host responses and increase risk of secondary ocular infections. Use in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.

May prolong course and exacerbate severity of many viral infections of the eye (including herpes simplex). Use great caution in patients with herpes simplex; frequent slit lamp microscopy recommended.

Consider possibility of fungal infections of the cornea after prolonged use; perform fungal cultures when appropriate.

Specific Populations

Pregnancy

Not known whether ophthalmic preparations containing bacitracin can cause fetal harm when administered to pregnant women.

Fixed combinations of bacitracin and polymyxin B with or without neomycin: Use during pregnancy only if clearly needed.

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: Use during pregnancy only if potential benefits justify potential risks to fetus.

Lactation

Not known whether bacitracin distributed into milk.

Bacitracin and fixed combinations of bacitracin and polymyxin B with or without neomycin: Use with caution in nursing women.

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: Discontinue nursing or the ophthalmic preparation, taking into account the importance of the drug to the woman.

Some experts consider topical bacitracin compatible with nursing.

Pediatric Use

Fixed combinations of bacitracin and polymyxin B with or without neomycin: Safety and efficacy not established in pediatric patients.

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

Geriatric Use

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: No substantial differences in safety or efficacy relative to younger adults.

Common Adverse Effects

Local irritation and allergic reactions (pruritus, edema of the conjunctiva and eyelid, conjunctival erythema).

Administration

Ophthalmic Administration

Apply topically into conjunctival sac of the eye as an ointment.

For topical ophthalmic use only; do not inject directly into anterior chamber of the eye.

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

Avoid contaminating container tip with material from eye, eyelid, or any other source.

Dosage

Dosage of bacitracin or bacitracin zinc expressed in terms of bacitracin.

Adults

Bacterial Ophthalmic Infections

Ophthalmic

Bacitracin (ophthalmic ointment): Apply to affected eye(s) 1–3 times daily.

Bacitracin and polymyxin B (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.

Bacitracin, neomycin, and polymyxin B (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days; 5–7 days usually adequate for mild bacterial conjunctivitis.

Ocular Inflammation

Ophthalmic

Bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours, depending on severity of the condition.

If no improvement after 48 hours, reevaluate patient. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Special Populations

No special population dosing recommendations.