Neomycin (EENT) (Monograph)

Brand name: Casporyn HC
Drug class: Antibacterials
ATC class: S01AA03
VA class: OT101
CAS number: 1405-10-3

Introduction

Antibacterial; aminoglycoside antibiotic.

Uses for Neomycin (EENT)

Bacterial Ophthalmic Infections

Used in fixed combination with other anti-infectives (i.e., polymyxin B and bacitracin; polymyxin B and gramicidin) for topical treatment of superficial infections of the eye (e.g., conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis) caused by susceptible bacteria.^{105 106 125 126}

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 colistin and hydrocortisone acetate or in fixed combination with polymyxin B and hydrocortisone for topical treatment of superficial infections of the external auditory canal (otitis externa) caused by susceptible bacteria.^{109 110 121 122 123 124 139} Also used for topical treatment of infections of mastoidectomy or fenestration cavities caused by susceptible bacteria.^{109 110 121 124}

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 neomycin, polymyxin B, and dexamethasone^{119 120} or fixed-combination ophthalmic preparations containing neomycin, polymyxin B, bacitracin, and hydrocortisone or hydrocortisone acetate^{107 108} 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-infectives; and/or increase IOP.^{107 108 119 120} (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Neomycin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Fixed combination of neomycin, polymyxin B, and bacitracin: Apply topically to eye as an ophthalmic ointment.^{105 106}

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

Fixed combination of neomycin, other anti-infectives (i.e., polymyxin B 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;^{105 106 107 108 119 120 125 126} do not inject subconjunctivally or directly into anterior chamber of the eye.^{105 106 107 108 119 120 125 126}

Avoid contaminating container tip with material from eye, eyelids, fingers, or other source.^{105 106 107 108 119 120 125 126}

Otic Administration

Fixed combination of neomycin, colistin, and hydrocortisone acetate: Apply topically into ear canal as an otic suspension.^{109 110}

Fixed combination of neomycin, polymyxin B, 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 the 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.^{109 110 121 122 123 124}

Dosage

Available as neomycin sulfate; dosage expressed in terms of the base.^{105 106 107 108 109 110 119 120 121 122 123 124 125 126}

Pediatric Patients

Bacterial Otic Infections

Otic

Neomycin, colistin, and hydrocortisone acetate in children ≥1 year of age (otic suspension): Instill 4 drops in affected ear(s) 3 or 4 times daily for up to 10 days.^{109 110}

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, and bacitracin (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours for 7–10 days, depending on severity of infection.^{105 106}

Neomycin, polymyxin B, and gramicidin (ophthalmic solution): Instill 1 or 2 drops in affected eye(s) every 4 hours for 7–10 days.^{125 126} For severe infections, may instill up to 2 drops every hour.^{125 126}

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

Neomycin, colistin, and hydrocortisone (otic suspension): Instill 5 drops in affected ear(s) 3 or 4 times daily for up to 10 days.^{109 110}

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, bacitracin, and hydrocortisone or hydrocortisone acetate (ophthalmic ointment): Apply to affected eye(s) every 3 or 4 hours, depending on severity of 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 Otic Infections

Otic

Neomycin, colistin, and hydrocortisone acetate in children ≥1 year of age: Maximum 10 days of therapy.^{109 110}

Neomycin, polymyxin B, and hydrocortisone in children ≥2 years of age: Maximum 10 days of therapy.^{121 122 123 124}

Adults

Bacterial Otic Infections

Otic

Neomycin, colistin, and hydrocortisone acetate: Maximum 10 days of therapy.^{109 110}

Neomycin, polymyxin B, and hydrocortisone: Maximum 10 days of therapy.^{121 122 123 124}

Special Populations

No special population dosage recommendations.^{105 106 107 108 109 110 119 120 121 122 123 124 125 126}

Cautions for Neomycin (EENT)

Contraindications

• Fixed combinations of neomycin and other anti-infectives (ophthalmic): Hypersensitivity to any ingredient in the formulation.^{105 106 125 126}

• Fixed combinations of neomycin, 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 neomycin, colistin, and hydrocortisone acetate (otic): Hypersensitivity to any ingredient in the formulation.^{109 110} Also, known or suspected viral infections of external ear canal (e.g., herpes simplex, varicella zoster).^{109 110}

• Fixed combinations of neomycin, polymyxin B, and hydrocortisone (otic): Hypersensitivity to any ingredient in the formulation.^{121 122 123 124} Also, known or suspected 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;^{105 106 107 108 119 120 121 122 123 124 125 126} more serious hypersensitivity reactions, including anaphylaxis, reported rarely^{105 106 107 108 119 120 121 122 123 124 125 126} .

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

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

Ophthalmic preparations: Sensitivity may manifest as rash, pruritus, edema of the conjunctiva and eyelid, conjunctival erythema, or failure to heal.^{105 106 107 108 119 120 125 126}

Otic preparations: Sensitivity may manifest as low-grade reddening with swelling, dry scaling, pruritus, or failure to heal.^{109 110 121 122 123 124}

If signs or symptoms of sensitivity occur, discontinue the drug.^{105 106 107 108 121 122 123 124 125 126} Symptoms usually subside quickly after preparation discontinued.^{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.^{105 106 107 108 121 122 123 124 125 126} Cross-allergenicity occurs among the aminoglycosides;^{109 110 119 120} patients allergic to neomycin may also be allergic to other aminoglycosides (e.g., gentamicin, paromomycin, streptomycin).^{105 106 107 108 119 120 121 122 123 124 125 126}

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.^{105 106 109 110 121 122 123 124 125 126} If superinfection occurs, discontinue the neomycin preparation and institute appropriate therapy.^{105 106 125 126}

Resistance to neomycin or other anti-infectives in fixed-combination preparations may develop.^{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.^{105 106 107 125 126}

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}

Some manufacturers caution that ophthalmic ointments may delay healing.^{105 106 107 108}

Precautions Related to Otic Administration

Otic preparations containing neomycin, colistin, and hydrocortisone acetate: Use with caution in patients with perforated tympanic membrane.^{109 110}

Otic preparations containing neomycin, polymyxin B, and hydrocortisone: Do not use 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.^{109 110 121 122 123 124}

Use otic preparations containing neomycin only under close clinical observation; do not use for longer than 10 consecutive days.^{109 110 121 122 123 124}

If used to control secondary infection in chronic otitis externa, consider that skin in this condition is more liable than normal skin to become sensitized to many substances, including neomycin.^{109 110 121 122 123 124} (See Hypersensitivity Reactions under Cautions.)

If otic infection not improved after 1 week of treatment, obtain cultures to guide treatment.^{109 110 121 122 123 124}

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 patients with persistent corneal ulceration.^{119 120} Perform fungal cultures when appropriate.^{107 108 119 120}

Specific Populations

Pregnancy

Not known whether ophthalmic preparations containing neomycin can cause fetal harm when administered to pregnant women.^{105 106 125 126}

Neomycin and other anti-infectives (ophthalmic): Use during pregnancy only if clearly needed.^{105 106 125 126}

Neomycin, 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}

Neomycin, colistin, and hydrocortisone acetate (otic): Use during pregnancy only if potential benefits justify potential risks to fetus.^{109 110} Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, manufacturers state that clinically important systemic concentrations of neomycin not anticipated when otic preparations containing neomycin are used as directed.^{109 110}

Neomycin, polymyxin B, and hydrocortisone (otic): Use during pregnancy only if potential benefits justify potential risks to fetus.^{121 122 123 124}

Lactation

Not known whether neomycin is distributed into milk.¹⁴⁴

Neomycin and other anti-infectives (ophthalmic): Use with caution.^{105 106 125 126}

Neomycin, polymyxin B, and dexamethasone (ophthalmic): Use with caution.^{119 120}

Neomycin, polymyxin B, bacitracin, and hydrocortisone or hydrocortisone acetate (ophthalmic): Discontinue nursing or the drug, taking into account importance of the drug to the woman.^{107 108}

Neomycin, colistin, and hydrocortisone acetate (otic): Use with caution.^{109 110}

Neomycin, polymyxin B, and hydrocortisone (otic): Use with caution.^{121 122 123 124}

Pediatric Use

Neomycin, polymyxin B, and bacitracin or gramicidin (ophthalmic): Safety and efficacy not established in pediatric patients.^{105 106 125 126}

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, bacitracin, and either hydrocortisone or hydrocortisone acetate (ophthalmic): Safety and efficacy not established in pediatric patients.^{107 108}

Neomycin, colistin, and hydrocortisone acetate (otic): Safety and efficacy not established in children <1 year of age.^{109 110}

Neomycin, polymyxin B, 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

Neomycin, polymyxin B, and gramicidin (ophthalmic): Clinical data insufficient to determine whether geriatric patients respond differently than younger adults;¹²⁵ other clinical experience has not identified differences in response.¹²⁵

Neomycin, polymyxin B, and dexamethasone (ophthalmic): No overall differences in safety or efficacy relative to younger patients.^{119 120}

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

Neomycin, colistin, and hydrocortisone acetate (otic): No overall differences in safety or efficacy relative to younger adults.^{109 110}

Neomycin, polymyxin B, and hydrocortisone (otic): Clinical data insufficient to determine whether geriatric patients respond differently than younger patients;^{121 122 123 124} other clinical experience has not identified differences in response.^{121 122 123 124}

Common Adverse Effects

Local irritation and allergic reactions.^{105 106 107 108 109 110 121 122 123 124 125 126}

Neomycin (EENT) Pharmacokinetics

Absorption

Bioavailability

Absorbed into the aqueous humor following topical instillation onto the eye in rabbits; absorption is greatest when cornea is abraded.^a

Absorbed through the ear in dogs, absorption greatest when tympanic membrane is perforated.^a

Stability

Storage

Ophthalmic

Ointment

Neomycin, polymyxin B, and bacitracin: 15–25°C.^{105 106}

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

Neomycin, polymyxin B, bacitracin, and hydrocortisone or hydrocortisone acetate: 15–25°C.^{107 108}

Solution

Neomycin, polymyxin B, and gramicidin: 15–25°C; protect from light.¹²⁵ Contains thimerosal as a preservative.^{125 126}

Suspension

Neomycin, polymyxin B, and dexamethasone: 8–25°C.¹²⁰ Contains benzalkonium chloride as a preservative.¹²⁰

Otic

Solution

Neomycin, polymyxin B, and hydrocortisone: 15–25°C.^{122 123} Contains potassium metabisulfite as a preservative (see Sulfite Sensitivity under Cautions).^{122 123}

Suspension

Neomycin, colistin, and hydrocortisone acetate: 20–25°C.^{109 110}

Neomycin, polymyxin B, and hydrocortisone: 15–25°C.^{121 124} Contains thimerosal as a preservative.^{121 124}

Actions and Spectrum

• Aminoglycoside antibiotic obtained from cultures of Streptomyces fradiae.^a

• Usually bactericidal.^a Appears to inhibit protein synthesis in susceptible bacteria by binding to ribosomal RNA and causing misreading of the bacterial genetic code.^a

• Neomycin: Spectrum of activity includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.^a Most streptococci are resistant.^a Inactive against fungi, viruses, and most anaerobic bacteria.^a

• Neomycin in fixed combination with polymyxin B: 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}

• Neomycin in fixed combination with polymyxin B and bacitracin: Active against S. aureus, streptococci (including S. pneumoniae), E. coli, H. influenzae, Enterobacter, Klebsiella, Neisseria, and Ps. aeruginosa.^{105 106 107 108 119 120 121 122 123 124} Does not provide coverage against S. marcescens.^{105 106 107 108}

• Neomycin in fixed combination with polymyxin B 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}

• Neomycin in fixed combination with colistin: Active in vitro and in superficial infections of the external auditory canal caused by S. aureus, E. aerogenes, E. coli, K. pneumoniae, and Ps. aeruginosa.^{109 110}

• Bacteria resistant to neomycin may emerge in patients receiving topical preparations containing the drug.^{105 106 125 126}

• There is partial cross-resistance between neomycin and other aminoglycosides.^a

Advice to Patients

• Advise patients to avoid contaminating container tip with material from eye, eyelid, ears, fingers, or other source^{105 106 107 108 109 110 119 120 121 122 123 124 125 126} and to not share ophthalmic or otic preparations with others.^{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.^{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}

• Advise patients to immediately discontinue therapy and contact a clinician if signs of sensitivity or allergic reaction occur (rash, pruritus, swelling, redness) or if the condition worsens or does not improve.^{105 106 107 108 109 110 121 122 123 124 125 126}

• 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 patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses^{105 106 107 108 109 110 119 120 121 122 123 124 125 126} .

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{105 106 107 108 109 110 119 120 121 122 123 124 125 126}

• Importance of informing patients of other important precautionary information.^{105 106 107 108 109 110 119 120 121 122 123 124 125 126} (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.

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