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Polymyxin B Sulfate eent

Class: Antibacterials
VA Class: OT101
CAS Number: 1405-20-5
Brands: Casporyn HC

Introduction

Antibacterial; polymyxin antibiotic.102 103 105 106 125 126 127 128

Uses for Polymyxin B Sulfate

Bacterial Ophthalmic Infections

Used in fixed combination with other anti-infectives (i.e., bacitracin; bacitracin and neomycin; neomycin and gramicidin; trimethoprim) for topical treatment of superficial infections of the eye (e.g., conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis) caused by susceptible bacteria.102 103 105 106 125 126 127 128

Used subconjunctivally for treatment of infections of the eye caused by susceptible Pseudomonas aeruginosa.104

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

Bacterial Otic Infections

Used in fixed combination with neomycin and a corticosteroid (i.e., hydrocortisone) for topical treatment of superficial infections of the external auditory canal (otitis externa) caused by susceptible bacteria.121 122 123 124 139 Also used for topical treatment of infections of mastoidectomy and fenestration cavities caused by susceptible bacteria.121 124

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid).139 143 Supplement with systemic anti-infective therapy if patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, HIV infection) or if infection has spread into pinna, skin of the neck or face, or into deeper tissues such as occurs with malignant otitis externa.139 Malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients, and requires prompt diagnosis and treatment with systemic anti-infectives.139

Ocular Inflammation

Fixed-combination ophthalmic preparations containing polymyxin B, neomycin, and dexamethasone119 120 or fixed-combination ophthalmic preparations containing polymyxin B, neomycin, bacitracin, and hydrocortisone or hydrocortisone acetate107 108 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.107 108 119 120

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,107 108 119 120 experts state avoid use of such preparations in patients with bacterial conjunctivitis because of risk of potentiating the infection.136

Consider that use of 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-infective; and/or increase IOP.107 108 119 120 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Polymyxin B Sulfate Dosage and Administration

Administration

Ophthalmic Administration (Topical)

Fixed combination of polymyxin B and bacitracin with or without neomycin: Apply topically to eye as an ophthalmic ointment.102 103 105 106

Fixed combination of polymyxin B, neomycin, and gramicidin: Apply topically to eye as an ophthalmic solution.125 126

Fixed combination of polymyxin B and trimethoprim: Apply topically to eye as an ophthalmic solution.127 128

Fixed combination of polymyxin B, other anti-infectives (i.e., neomycin with or without bacitracin), and a corticosteroid (i.e., dexamethasone, hydrocortisone, or hydrocortisone acetate): Apply topically to eye as ophthalmic ointments or suspensions.107 108 119 120

For topical ophthalmic use only;103 105 106 107 108 119 120 125 126 127 128 do not inject subconjunctivally or directly into anterior chamber of the eye.103 105 106 107 108 119 120 125 126 127 128

Avoid contaminating container tip with material from eye, eyelids, fingers, or other source.103 105 106 107 108 119 120 125 126 127 128

Ophthalmic Administration (Subconjunctival)

Has been administered by subconjunctival injection.104

For subconjunctival administration, reconstitute vial containing sterile powder for injection (500,000 units of polymyxin B) by adding 20–50 mL of sterile water for injection or 0.9% sodium chloride injection to provide a solution containing 10,000–25,000 units/mL.104 Administer appropriate dose of reconstituted solution by subconjunctival injection.104

Otic Administration

Fixed combination of polymyxin B, neomycin, and hydrocortisone: Apply topically into ear canal as an otic solution or suspension.121 122 123 124

Otic preparations are for topical otic use only;121 122 123 124 do not use in the eyes.122 123 124

Clean and dry ear canal prior to administration.121 122 123 124

Shake otic suspensions well prior to each use.121 124

Lie with the affected ear upward.121 122 123 124 Instill appropriate amount of otic solution or suspension into ear; maintain this position for 5 minutes to facilitate penetration into ear canal.121 122 123 124 Repeat procedure for opposite ear if necessary.121 122 123 124

If ear canal is narrow or edematous and there are concerns that drug delivery might be impeded,139 consider inserting cotton wick into ear canal and saturating it with the otic preparation.121 122 123 124 Manufacturers state keep wick moist by adding additional otic solution or suspension every 4 hours and replace wick once every 24 hours.121 122 123 124 Experts state that wick unnecessary after ear canal edema subsides, which may occur within 24 hours or a few days after topical treatment initiated.139

Avoid contaminating container tip with material from ear, fingers, or other source.121 122 123 124

Dosage

Available as polymyxin B sulfate; potency and dosage expressed in terms of polymyxin B activity (units of polymyxin B).102 103 104 105 106 107 108 119 120 121 122 123 124 125 126 127 128

Pediatric Patients

Bacterial Ophthalmic Infections
Ophthalmic

Polymyxin B and trimethoprim in infants and children ≥2 months of age (ophthalmic solution): Instill 1 drop in affected eye(s) every 3 hours (maximum of 6 doses daily) for 7–10 days.127 128

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;135 136 141 5–7 days usually adequate for mild bacterial conjunctivitis.135

Bacterial Otic Infections
Otic

Polymyxin B, neomycin, and hydrocortisone in children ≥2 years of age (otic solution or suspension): Instill 3 drops in affected ear(s) 3 or 4 times daily for up to 10 days.121 122 123 124

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended.139 Appropriate treatment should result in improvement in symptoms (otalgia, pruritus, fullness) within 48–72 hours, although resolution of symptoms may take up to 2 weeks.139

Ocular Inflammation
Ophthalmic

Polymyxin B, neomycin, and dexamethasone in children ≥2 years of age (ophthalmic suspension): Instill 1 or 2 drops in conjunctival sac of affected eye(s) up to 4–6 times daily.120 In severe disease, instill 1 or 2 drops every hour initially, then taper dosage by decreasing frequency of administration as inflammation subsides.120

If no improvement after 48 hours, reevaluate patient.107 108 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Adults

Bacterial Ophthalmic Infections
Ophthalmic (Topical)

Polymyxin B and bacitracin with or without neomycin (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.102 103 105 106

Polymyxin B, neomycin, and gramicidin (ophthalmic solution): Instill 1 or 2 drops in affected eye(s) every 4 hours for 7–10 days.125 126 May instill up to 2 drops every hour for severe infections.125 126

Polymyxin B and trimethoprim (ophthalmic solution): Instill 1 drop in affected eye(s) every 3 hours (maximum of 6 doses daily) for 7–10 days.127 128

Usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5–10 days;135 136 141 5–7 days usually adequate for mild bacterial conjunctivitis.135

Ophthalmic (Subconjunctival)

Up to 100,000 units daily using reconstituted solution containing 10,000–25,000 units/mL.104

If used in conjunction with topical polymyxin B, total dosage should not exceed 25,000 units/kg daily.104

Bacterial Otic Infections
Otic

Polymyxin B, neomycin, and hydrocortisone (otic solution or suspension): Instill 4 drops in affected ear(s) 3 or 4 times daily for up to 10 days.121 122 123 124

Optimal duration of topical treatment of acute otitis externa not determined, but 7–10 days usually recommended.139 Appropriate treatment should result in improvement in symptoms (otalgia, pruritus, fullness) within 48–72 hours, although resolution of symptoms may take up to 2 weeks.139

Ocular Inflammation
Ophthalmic

Polymyxin B, neomycin, and dexamethasone (ophthalmic ointment): Apply approximately 1.25 cm (½ inch) of ointment in conjunctival sac of affected eye(s) up to 3 or 4 times daily.119

Polymyxin B, neomycin, and dexamethasone (ophthalmic suspension): Instill 1 or 2 drops in conjunctival sac of affected eye(s) up to 4–6 times daily.120 In severe disease, instill 1 or 2 drops every hour initially, then taper dosage by decreasing frequency of administration as inflammation subsides.120

Polymyxin B, neomycin, bacitracin, and hydrocortisone or hydrocortisone acetate (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours, depending on severity of the condition.107 108

If no improvement after 48 hours, reevaluate patient.107 108 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Prescribing Limits

Pediatric Patients

Bacterial Ophthalmic Infections
Ophthalmic

Polymyxin B and trimethoprim in infants and children ≥2 months of age (ophthalmic solution): Maximum 6 doses in 24 hours.127 128

Bacterial Otic Infections
Otic

Polymyxin B, neomycin, and hydrocortisone in children ≥2 years of age (otic solution or suspension): Maximum 10 consecutive days of therapy.121 122 123 124

Adults

Bacterial Ophthalmic Infections
Ophthalmic

Polymyxin B and trimethoprim (ophthalmic solution): Maximum 6 doses in 24 hours.127 128

Bacterial Otic Infections
Otic

Polymyxin B, neomycin, and hydrocortisone (otic solution or suspension): Maximum 10 consecutive days of therapy.121 122 123 124

Special Populations

No special population dosage recommendations.102 103 105 106 125 126 127 128

Cautions for Polymyxin B Sulfate

Contraindications

  • Polymyxin B: Hypersensitivity to polymyxins.104

  • Fixed combinations of polymyxin B and other anti-infectives (ophthalmic): Hypersensitivity to any ingredient in the formulation.102 103 105 106 125 126 127 128

  • Fixed combinations of polymyxin B, other anti-infectives, and dexamethasone, hydrocortisone, or hydrocortisone acetate (ophthalmic): Hypersensitivity to any ingredient in the formulation.107 108 119 120 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.107 108 119 120

  • Fixed combinations of polymyxin B, neomycin, and hydrocortisone (otic): Hypersensitivity to any ingredient in the formulation.121 122 123 124 Also, viral infections of external ear canal (e.g., herpes simplex, vaccinia, varicella zoster).121 122 123 124

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Local irritation and allergic reactions reported;103 105 106 107 108 119 120 121 122 123 124 125 126 127 128 more serious hypersensitivity reactions, including anaphylaxis, reported rarely.103 105 106 107 108 119 120 125 126 127 128

Topical anti-infectives, particularly neomycin, may cause cutaneous sensitization.103 105 106 107 108 119 120 121 122 123 124 125 126

During long-term use, periodically examine patient for signs of sensitization.103 105 106 107 108 121 122 123 124 125 126

Ophthalmic preparations: Sensitization may manifest as rash, pruritus, edema of the conjunctiva and eyelid, conjunctival erythema, or failure to heal.103 105 106 107 108 125 126 127 128

Otic preparations: Sensitization may manifest as swelling, dry scaling, pruritus, or failure to heal.121 122 123 124

If signs or symptoms of sensitivity occur, discontinue the drug.103 105 106 107 108 121 122 123 124 125 126 127 128 Symptoms usually subside quickly after preparation discontinued.103 105 106 107 108 121 122 123 124 125 126

Patients allergic to one fixed-combination preparation should avoid preparations containing any of the component drugs.103 105 106 107 108 121 122 123 124 125 126 Cross-allergenicity occurs among the aminoglycosides;119 120 patients allergic to fixed-combination preparations containing neomycin may also be allergic to other aminoglycosides (e.g., gentamicin, paromomycin, streptomycin).103 105 106 107 108 121 122 123 124 125 126

Sulfite Sensitivity

Some fixed-combination otic preparations contain potassium metabisulfite,122 123 a sulfite that can cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.111 112 113 114 115 116 117 118 122 123

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.102 103 104 105 106 121 122 123 124 125 126 127 128 If superinfection occurs, institute appropriate therapy.102 103 105 106 125 126 127 128

Resistance to polymyxin B or other anti-infectives in fixed-combination preparations may develop.103 105 106 125 126

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

Do not wear contact lenses if any signs or symptoms of ocular infection are present.127 128

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

Precautions Related to Otic Administration

Do not use fixed-combination otic preparations containing polymyxin B, neomycin, and hydrocortisone in patients with perforated tympanic membrane.121 122 123 124

Neomycin, especially with prolonged use, can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti.121 122 123 124 Use otic preparations containing neomycin only under close clinical observation; do not use for longer than 10 consecutive days.121 122 123 124

If otic infection not improved after 1 week of treatment, obtain cultures to guide treatment.121 122 123 124

Use of Fixed Combinations Containing Corticosteroids

When ophthalmic or otic preparations containing polymyxin B in fixed combination with other anti-infectives and a corticosteroid (i.e., dexamethasone, hydrocortisone, hydrocortisone acetate) are used, consider cautions, precautions, and contraindications associated with EENT corticosteroids.107 108 119 120 121 122 123 124

Provide initial prescriptions for fixed-combination ophthalmic preparations containing a corticosteroid or renewal prescriptions (beyond 8 g of ophthalmic ointment or beyond 20 mL of ophthalmic suspension) only after examining patient with slit lamp microscopy and, when appropriate, fluorescein staining.107 108 119 120

Reevaluate patient if eye pain or inflammation persists for >48 hours or becomes aggravated.108 119 120

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.107 108 119 120 If used for ≥10 days, monitor IOP regularly, even though monitoring may be difficult in children and uncooperative patients.107 108 119 120 Use with caution in patients with glaucoma; check IOP frequently in such patients.107 108 119 120

Use after cataract surgery may delay healing and increase incidence of bleb formation.107 108 119 120

Corneal and scleral thinning reported with various ocular diseases and with long-term use of topical ophthalmic corticosteroids.108 120 Use in patients with thin corneal and scleral tissue may result in perforation.107 108 119 120

Prolonged use may suppress host responses and increase risk of secondary ocular infections.107 108 119 120 Use in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.107 108 119 120

May prolong course and exacerbate severity of many viral infections of the eye (including herpes simplex).107 108 119 120 Use great caution in patients with herpes simplex; frequent slit lamp microscopy recommended.107 108 119 120

Consider possibility of fungal infections of the cornea after prolonged use,107 108 119 120 especially in those with persistent corneal ulceration.119 120 Perform fungal cultures when appropriate.107 108 119 120

Specific Populations

Pregnancy

Not known whether ophthalmic preparations containing polymyxin B can cause fetal harm when administered to pregnant women.103 105 106 125 126

Polymyxin B and bacitracin with or without neomycin (ophthalmic): Use during pregnancy only if clearly needed.103 105 106

Polymyxin B, neomycin, and gramicidin (ophthalmic): Use during pregnancy only if clearly needed.106 125 126

Polymyxin B and trimethoprim (ophthalmic): Use during pregnancy only if potential benefits justify potential risks to fetus; trimethoprim may interfere with folic acid metabolism.127 128

Polymyxin B, other anti-infectives, and dexamethasone, hydrocortisone, or hydrocortisone acetate (ophthalmic): Use during pregnancy only if potential benefits justify potential risks to fetus.107 108 119 120

Polymyxin B, neomycin, and hydrocortisone (otic): Use during pregnancy only if potential benefits justify potential risks to fetus.121 122 123 124

Lactation

Polymyxin B and other anti-infectives (ophthalmic): Use with caution.103 105 106 125 126 127 128

Polymyxin B, neomycin, and dexamethasone (ophthalmic): Use with caution.119 120

Polymyxin B, neomycin, bacitracin, and hydrocortisone or hydrocortisone acetate (ophthalmic): Discontinue nursing or the drug, taking into account importance of the drug to the woman.107 108

Polymyxin B, neomycin, and hydrocortisone (otic): Use with caution.121 122 123 124

Pediatric Use

Polymyxin B and bacitracin with or without neomycin (ophthalmic): Safety and efficacy not established in pediatric patients.103 105 106

Polymyxin B, neomycin, and gramicidin (ophthalmic): Safety and efficacy not established in pediatric patients.125 126

Polymyxin B and trimethoprim (ophthalmic): Safety and efficacy not established in infants <2 months of age.127 128

Polymyxin B, neomycin, and dexamethasone (ophthalmic): Safety and efficacy of the suspension not established in children <2 years of age;120 safety and efficacy of the ointment not established in pediatric patients.119

Polymyxin B, neomycin, bacitracin, and hydrocortisone or hydrocortisone acetate (ophthalmic): Safety and efficacy not established in pediatric patients.107 108

Polymyxin B, neomycin, and hydrocortisone (otic): Most manufacturers state safety and efficacy not established in children <2 years of age because of insufficient data.122 123 124 One manufacturer states safety and efficacy have been established in pediatric patients and does not specify an age range.121

Geriatric Use

Polymyxin B, neomycin, and gramicidin (ophthalmic): Clinical data insufficient to determine whether geriatric patients respond differently than younger adults.125

Polymyxin B and trimethoprim (ophthalmic): No overall differences in safety or efficacy relative to younger adults.127 128

Polymyxin B, neomycin, and dexamethasone (ophthalmic): No overall differences in safety or efficacy relative to younger patients.119 120

Polymyxin B, neomycin, bacitracin, and hydrocortisone acetate (ophthalmic): No overall differences in safety or efficacy relative to younger adults.108

Polymyxin B, neomycin, and hydrocortisone (otic): Clinical data insufficient to determine whether geriatric patients respond differently than younger patients; other clinician experience has not identified differences in response.121 122 123 124

Common Adverse Effects

Local irritation and allergic reactions.103 105 106 107 108 119 120 121 122 123 124 125 126 127 128

Polymyxin B Sulfate Pharmacokinetics

Absorption

Bioavailability

Minimal or no absorption from intact or denuded skin or from mucous membranes.a

Stability

Storage

Ophthalmic

Ointment

Polymyxin B and bacitracin: 15–25°C.102 103

Polymyxin B, neomycin, and bacitracin: 15–25°C.105 106

Polymyxin B, neomycin, and dexamethasone: 2–25°C.119 Contains methylparaben and propylparaben as preservatives.119

Polymyxin B, neomycin, bacitracin, and hydrocortisone or hydrocortisone acetate: 15–25°C.107 108

Solution

Polymyxin B, neomycin, and gramicidin: 15–25°C;125 126 protect from light.125 Contains thimerosal as a preservative.125 126

Polymyxin B and trimethoprim: 15–25°C; protect from light.127 128 Contains benzalkonium chloride as a preservative.127 128

Suspension

Polymyxin B, neomycin, and dexamethasone: 8–25°C; store upright.120 Contains benzalkonium chloride as a preservative.120

Powder for Injection

Polymyxin B: 20–25°C; protect from light.104

After reconstitution, store at 2–8°C; discard unused portions after 72 hours.104

Otic

Solution or Suspension

Polymyxin B, neomycin, and hydrocortisone: 15–25°C.121 122 123 124 Solutions contain potassium meta bisulfite as a preservative (see Sulfite Sensitivity under Cautions);122 123 suspensions contain thimerosal as a preservative.121 124

Actions and Spectrum

  • Polymyxin antibiotic derived from Bacillus polymyxa.a

  • Usually bactericidal.a Increases permeability of the bacterial cell wall membrane by interacting with phospholipid components of the cell membrane.a

  • Polymyxin B: Spectrum of activity includes many aerobic gram-negative bacteria.a Inactive against gram-positive bacteria and fungi.

  • Polymyxin B in fixed combination with neomycin: Active against Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Enterobacter, Klebsiella, Neisseria, and Pseudomonas aeruginosa.119 120 121 122 123 124 Does not provide coverage against streptococci (including Streptococcus pneumoniae) or Serratia marcescens.119 120 121 122 123 124

  • Polymyxin B in fixed combination with bacitracin with or without neomycin: Active against S. aureus, streptococci (including S. pneumoniae), E. coli, H. influenzae, Enterobacter, Klebsiella, Neisseria, and Ps. aeruginosa.105 106 107 108 Does not provide coverage against S. marcescens.105 106 107 108

  • Polymyxin B in fixed combination with neomycin and gramicidin: Active against S. pneumoniae, E. coli, H. influenzae, Enterobacter, Klebsiella, Neisseria, and Ps. aeruginosa.125 126 Does not provide coverage against S. marcescens.125 126

  • Polymyxin B in fixed combination with trimethoprim: Active against S. aureus, S. epidermidis, S. pneumoniae, viridans streptococci, H. influenzae, and Ps. aeruginosa.127 128

  • Bacteria resistant to polymyxin B may emerge in patients receiving topical preparations containing the drug.103 105 106 125 126

  • Complete cross-resistance occurs between polymyxin B and colistin.a

Advice to Patients

  • Advise patients to avoid contaminating container tip with material from eye, eyelid, ears, fingers, or other source.103 105 106 107 108 119 120 121 122 123 124 125 126 127 128 Importance of not sharing ophthalmic or otic preparations with others103 105 106 107 108 119 120 125 126

  • 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

  • Inform patients that their vision may be temporarily blurred after administration of topical ophthalmic preparations;119 120 take care in operating machinery or driving a motor vehicle.119 120

  • Importance of not wearing contact lenses if any signs or symptoms of eye infection are present.127 128

  • 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 condition worsens or does not improve.103 105 106 107 108 121 122 123 124 125 126 127 128

  • 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.108 119 120

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.103 105 106 107 108 119 120 121 122 123 124 125 126 127 128

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.103 105 106 107 108 119 120 121 122 123 124 125 126 127 128

  • Importance of informing patients of other important precautionary information.103 105 106 107 108 119 120 121 122 123 124 125 126 127 128 (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

Polymyxin B Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

500,000 units (of polymyxin B)*

Polymyxin B Sulfate for Injection

* 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

Ophthalmic

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 Ophthalmic Ointment

* 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 3.5 mg (of neomycin) per g, 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 Ophthalmic Ointment

Neosporin Ophthalmic Ointment

Burroughs Wellcome

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

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

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

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

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 3.5 g (of neomycin) per g, 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 Ophthalmic Ointment

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

Neomycin and Polymyxin B Sulfates and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Neomycin Sulfate 3.5 g (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Dexamethasone 0.1%*

Maxitrol

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment

Suspension

Neomycin Sulfate 3.5 mg (of neomycin) per mL, Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Dexamethasone 0.1%*

Maxitrol

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension

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

Neomycin and Polymyxin B Sulfates and Gramicidin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

Neomycin Sulfate 1.75 mg (of neomycin) per mL, Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Gramicidin 0.025 mg per mL*

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution

Neosporin Ophthalmic Solution

Pfizer

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

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 3.5 mg (of neomycin) per mL, Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension

Otic

Solution

Neomycin Sulfate 3.5 mg (of neomycin) per mL, Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Cortisporin Otic Solution

Pfizer

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution

Suspension

Neomycin Sulfate 3.5 mg (of neomycin) per mL, Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Casporyn HC

Casper

Neosporin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension

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

Polymyxin B Sulfate and Trimethoprim Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL and Trimethoprim Sulfate 1 mg (of trimethoprim) per mL*

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

Polytrim

Allergan

AHFS DI Essentials. © Copyright 2018, Selected Revisions May 14, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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

102. Bausch & Lomb. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Tampa, FL; 2013 Mar.

103. E. Fougera & Co. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Melville, NY; 2007 Oct.

104. X-Gen Pharmaceuticals. Polymyxin B for injection, USP for parenteral and ophthalmic administration prescribing information. Big Flats, NY; 2015 May.

105. MWI. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment USP prescribing information. Boise, ID; 2016 Oct.

106. Burroughs Wellcome. Neosporin (neomycin and polymyxin B sulfates and bacitracin zinc) ophthalmic ointment USP prescribing information. Research Triangle Park, NC; undated.

107. Bausch & Lomb. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment USP prescribing information. Bridgewater, NJ; 2016 Nov.

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

111. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. http://www.ncbi.nlm.nih.gov/pubmed/6604672?dopt=AbstractPlus

112. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. http://www.ncbi.nlm.nih.gov/pubmed/6716628?dopt=AbstractPlus

113. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. http://www.ncbi.nlm.nih.gov/pubmed/6716626?dopt=AbstractPlus

114. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. http://www.ncbi.nlm.nih.gov/pubmed/7120631?dopt=AbstractPlus

115. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. http://www.ncbi.nlm.nih.gov/pubmed/7334982?dopt=AbstractPlus

116. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. http://www.ncbi.nlm.nih.gov/pubmed/6630799?dopt=AbstractPlus

117. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N 0113] Fed Regist. 1985; 50:47558 63.

118. Food and Drug Administration Center for Food Safety and Applied Nutrition. The reexamination of the GRAS status of sulfiting agents, January 1985. (Doc. No. 223-83-2020.) Bethesda, MD: FASEB Life Sciences Research Office.

119. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2017 Dec.

120. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates and dexamethasone) ophthalmic suspension prescribing information. Fort Worth, TX; 2017 Dec.

121. Casper Pharma. Casporyn HC (neomycin and polymyxin B sulfates and hydrocortisone) otic suspension, USP. East Brunswick, NJ; 2017 Dec.

122. Bausch & Lomb. Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP prescribing information. Bridgewater, NJ; 2016 Aug.

123. Pfizer Laboratories. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone) otic solution, USP prescribing information. New York, NY; 2016 Aug.

124. Bausch & Lomb. Neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP prescribing information. Bridgewater, NJ; 2016 Aug.

125. Pfizer. Neosporin (neomycin and polymyxin B sulfates and gramicidin) ophthalmic solution, USP prescribing information. Bristol, TN; 2016 Jul.

126. Bausch & Lomb. Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP prescribing information. Bridgewater, NJ; 2016 Jun.

127. Allergan. Polytrim (polymyxin B sulfate and trimethoprim sulfate) ophthalmic solution prescribing information. Irvine, CA; 2004 Aug.

128. Bausch & Lomb. Polymyxin B sulfate and trimethoprim ophthalmic solution, USP prescribing information. Bridgewater, NJ. 2016 Jun.

135. American Academy of Ophthalmology. Preferred practice pattern (PPP) guidelines: conjunctivitis PPP - 2013. From American Academy of Ophthalmology website. Accessed 20 Dec 2017. http://www.aao.org/preferred-practice-pattern/conjunctivitis-ppp--2013

136. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA. 2013; 310:1721-9. http://www.ncbi.nlm.nih.gov/pubmed/24150468?dopt=AbstractPlus

137. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev. 2012; :CD001211. http://www.ncbi.nlm.nih.gov/pubmed/22972049?dopt=AbstractPlus

138. American Academy of Ophthalmology. Preferred Practice Pattern (PPP) guidelines: bacterial keratitis - 2013. From the American Academy of Ophthalmology website. Accessed 5 Dec 2016. https://www.aao.org/preferred-practice-pattern/bacterial-keratitis-ppp--2013

139. Rosenfeld RM, Schwartz SR, Cannon CR et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014; 150(1 Suppl):S1-S24. http://www.ncbi.nlm.nih.gov/pubmed/24491310?dopt=AbstractPlus

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

141. Barnes SD, Kumar NM, Pavin-Langston D et al. Microbial Conjunctivitis. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:1392-1401.

143. Kaushik V, Malik T, Saeed SR. Interventions for acute otitis externa. Cochrane Database Syst Rev. 2010; :CD004740. http://www.ncbi.nlm.nih.gov/pubmed/20091565?dopt=AbstractPlus

a. AHFS Drug Information 2018. McEvoy GK, ed. Polymyxin B sulfate. Bethesda, MD: American Society of Health-System Pharmacists. 2018.

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