Neosporin eent

Bacterial Ophthalmic Infections

Topical treatment of superficial infections of the eye involving the conjunctiva and/or cornea caused by susceptible bacteria.101

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.102 103 105 106

Mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment.135 136 137 141 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,135 136 137 141 avoid indiscriminate use of topical anti-infectives.135 141 Treatment of acute bacterial conjunctivitis generally is empiric;135 136 141 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.135 136 141 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.135 136 141

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.138 Treatment of community-acquired bacterial keratitis generally is empiric;138 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.138 Subconjunctival anti-infectives may be necessary if scleral spread or perforation is imminent.138 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.138

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.107 108

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,107 108 experts state avoid use of such preparations in patients with bacterial conjunctivitis because of risk of potentiating the infection.136

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.107 108 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Contraindications

• Known hypersensitivity to bacitracin or any ingredient in the formulation.101

• Fixed combinations of bacitracin and polymyxin B with or without neomycin: Hypersensitivity to any ingredient in the formulation.102 103 105 106

• 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.107 108 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.107 108

Warnings/Precautions

Sensitivity Reactions

Local irritation and allergic reactions reported (e.g., pruritus, reddening, conjunctival or eyelid edema);103 105 106 107 108 more serious hypersensitivity reactions, including anaphylaxis, reported rarely.103 105 106 107 108

Topical anti-infectives, particularly neomycin, may cause cutaneous sensitization.103 105 106 107 108

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.103 105 106 107 108

If signs or symptoms of sensitivity occur, discontinue the drug.103 105 106 107 108 Symptoms usually subside quickly after ophthalmic preparation discontinued.103 105 106 107 108

Patients allergic to one fixed-combination ophthalmic preparation should avoid preparations containing any of the component drugs.103 105 106 107 108 In addition, patients allergic to fixed combinations containing neomycin may also be allergic to other aminoglycoside (e.g., gentamicin, paromomycin, streptomycin).103 105 106 107 108

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.101 102 103 105 106 Initiate appropriate therapy if superinfection occurs.101 102 103 105 106

Resistance to bacitracin or other anti-infectives in fixed-combination preparations (i.e., polymyxin B, neomycin) may develop.103 105 106

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.103 105 106 107 108

Manufacturers caution that ophthalmic ointments may delay healing.102 103 105 106 107 108

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.107 108

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.107 108

Reevaluate patient if inflammation or pain persists for >48 hours or becomes aggravated.107 108

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.107 108 If used for ≥10 days, monitor IOP regularly, even though monitoring may be difficult in children and uncooperative patients.107 108 Use with caution in patients with glaucoma; check IOP frequently in such patients.107 108

Use after cataract surgery may delay healing and increase incidence of bleb formation.107 108

Corneal and scleral thinning reported with various ocular diseases and with long-term use of topical ophthalmic corticosteroids.107 108 Use in patients with thin corneal and scleral tissue may result in perforation.107 108

Prolonged use may suppress host responses and increase risk of secondary ocular infections.107 108 Use in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.107 108

May prolong course and exacerbate severity of many viral infections of the eye (including herpes simplex).107 108 Use great caution in patients with herpes simplex; frequent slit lamp microscopy recommended.107 108

Consider possibility of fungal infections of the cornea after prolonged use;107 108 perform fungal cultures when appropriate.107 108

Specific Populations

Not known whether ophthalmic preparations containing bacitracin can cause fetal harm when administered to pregnant women.103 105 106

Fixed combinations of bacitracin and polymyxin B with or without neomycin: Use during pregnancy only if clearly needed.103 105 106

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: Use during pregnancy only if potential benefits justify potential risks to fetus.107 108

Not known whether bacitracin distributed into milk.103 105 106

Bacitracin and fixed combinations of bacitracin and polymyxin B with or without neomycin: Use with caution in nursing women.103 105 106

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.107 108

Some experts consider topical bacitracin compatible with nursing.140

Fixed combinations of bacitracin and polymyxin B with or without neomycin: Safety and efficacy not established in pediatric patients.103 105 106

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: Safety and efficacy not established in pediatric patients.107 108

Fixed combinations of bacitracin, neomycin, polymyxin B, and hydrocortisone or hydrocortisone acetate: No substantial differences in safety or efficacy relative to younger adults.108

Common Adverse Effects

Local irritation and allergic reactions (pruritus, edema of the conjunctiva and eyelid, conjunctival erythema).103 105 106 107 108

• Advise patients to avoid contaminating container tip with material from eye, eyelid, fingers, or any other surface.101 103 105 106 107 108 Importance of not sharing ophthalmic preparations with others.103 105 106 107 108

• Inform patients that serious eye damage and subsequent vision loss may occur if ophthalmic preparations are handled improperly and become contaminated by common bacteria known to cause ocular infections.103 105 106 107

• Advise patients to immediately discontinue therapy and contact a clinician if any signs of sensitivity or allergic reaction (e.g., rash, pruritus, swelling, redness) occur or if the infection worsens or does not improve.101 103 105 106 107

• Advise patients using fixed-combination ophthalmic preparations containing a corticosteroid to discontinue the drug and contact a clinician if inflammation or pain persists for >48 hours or becomes aggravated.108

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.101 103 105 106 107 108

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101 103 105 106 107 108

• Importance of informing patients of other important precautionary information.101 103 105 106 107 108 (See Cautions.)

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

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

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

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

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

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