Medication Guide App

Neomycin Sulfate eent

Class: Antibacterials
ATC Class: S01AA03
VA Class: OT101
CAS Number: 1405-10-3
Brands: Coly-Mycin S, Cortisporin, Maxitrol, Neosporin, Pediotic, Poly-Pred

Introduction

Antibacterial; aminoglycoside antibiotic produced by Streptomyces fradiae.a b c d e f k l

Uses for Neomycin Sulfate

Bacterial Ophthalmic Infections

Used in fixed combination with other anti-infectives (e.g., polymyxin B with bacitracin or gramicidin) for treatment of superficial infections of the eye caused by susceptible bacteria.b f

Used in fixed combination with corticosteroids and other anti-infectives when such combination therapy is indicated.a d h i j

Bacterial Otic Infections

Used in fixed combination with other anti-infectives and corticosteroids for treatment of otitis externa caused by susceptible bacteria.c e g k

Neomycin Sulfate Dosage and Administration

Administration

Ophthalmic Administration

In fixed combination with other anti-infectives or corticosteroids, apply topically to the eye as an ophthalmic ointment, solution, or suspension.a b d h

Not for injection; do not inject subconjunctivally or directly into the anterior chamber of the eye.a b d h i j

Avoid contamination of preparation container.a b d h

Shake suspension well prior to each use.a h

To treat eyelids, instill into the eye, then close the eye and rub the excess onto the lids and lid margins.h

Otic Administration

In fixed combination with other anti-infectives and corticosteroids, instill into the external ear as an otic solution or suspension.c e g

Otic preparations are not for use in the eye.c e g k

Clean and dry ear canal prior to administration.c e g k Lie with the affected ear upward, then instill the otic preparation into the ear canal; maintain this position for 5 minutes.c e g k Repeat procedure if necessary for the opposite ear.c e g k

Shake suspension well prior to each use.e g k

Use the dropper provided by the manufacturer for otic solutions or suspensions.k

Avoid contamination of preparation container.g

Dosage

Available as neomycin sulfate; dosage expressed in terms of the salt.a b c d e f g k l

Pediatric Patients

Bacterial Otic Infections
Neomycin and Colistin Sulfates and Hydrocortisone Acetate
Otic Suspension

Children: 4 drops into affected ear(s) 3 or 4 times daily for up to 10 days.k

Alternatively, insert a cotton wick saturated with the suspension into the ear canal; keep the wick moist by adding additional drug every 4 hours.k Replace the wick at least once every 24 hours.k

Neomycin and Polymyxin B Sulfates and Hydrocortisone
Otic Solution or Suspension

Children ≥2 years of age: 3 drops into the affected ear(s) 3 or 4 times daily for up to 10 days.c e g

Alternatively, insert a cotton wick saturated with the otic preparation into the canal; keep the wick moist by adding additional drug every 4 hours.c e g Replace the wick at least once every 24 hours.c e g

Adults

Bacterial Ophthalmic Infections
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Ophthalmic Ointment

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

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

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

Neomycin and Polymyxin B Sulfates and Dexamethasone
Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.i

Ophthalmic Suspension

Mild infections: 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) up to 4–6 times daily.j

Severe infections: 1 or 2 drops into the conjunctival sac of the affected eye(s) hourly.j Reduce dosing frequency as infection improves.j

Neomycin and Polymyxin B Sulfates and Gramicidin
Ophthalmic Solution

1 or 2 drops into the affected eye(s) every 4 hours for 7–10 days.b

Severe infections: Up to 2 drops into the affected eye(s) every hour.b

Neomycin and Polymyxin B Sulfates and Hydrocortisone
Ophthalmic Suspension

1 or 2 drops into the affected eye(s) every 3 or 4 hours, or more frequently if necessary.a

Neomycin and Polymyxin B Sulfates and Prednisolone Acetate
Ophthalmic Suspension

1 or 2 drops into the affected eye(s) every 3 or 4 hours, or more frequently, as required.h For acute infections, may administer every 30 minutes.h Reduce dosing frequency as infection improves.h

To treat eyelids: 1 or 2 drops into the affected eye(s) every 3 to 4 hours.h (See Administration under Dosage and Administration.)

Bacterial Otic Infections
Neomycin and Colistin Sulfates and Hydrocortisone Acetate
Otic Suspension

5 drops into affected ear(s) 3 or 4 times daily for up to 10 days.k

Alternatively, insert a cotton wick saturated with the suspension into the ear canal; keep the wick moist by adding additional drug every 4 hours.k Replace the wick at least once every 24 hours.k

Neomycin and Polymyxin B Sulfates and Hydrocortisone
Otic Solution or Suspension

4 drops into the affected ear(s) 3 or 4 times daily for up to 10 days.c e g

Alternatively, insert a cotton wick saturated with the otic preparation into the canal; keep the wick moist by adding additional drug every 4 hours.c e g Replace the wick at least once every 24 hours.c e g

Prescribing Limits

Pediatric Patients

Bacterial Otic Infections
Neomycin and Colistin Sulfates and Hydrocortisone Acetate
Otic Suspension

Maximum 10 days of therapy.k

Neomycin and Polymyxin B Sulfates and Hydrocortisone
Otic Solution and Suspension

Children ≥2 years of age: Maximum 10 consecutive days of therapy.c e g

Adults

Bacterial Otic Infections
Neomycin and Colistin Sulfates and Hydrocortisone Acetate
Otic Suspension

Maximum 10 days of therapy.k

Neomycin and Polymyxin B Sulfates and Hydrocortisone
Otic Solution and Suspension

Maximum 10 consecutive days of therapy.c e g

Special Populations

No special population dosage recommendations at this time.a b c d e g h i j k l

Cautions for Neomycin Sulfate

Contraindications

  • Known hypersensitivity to neomycin or any ingredient in the formulation.a b c d e f g h i j k l

Warnings/Precautions

Warnings

Ototoxicity

With otic administration, neomycin can induce permanent sensorineural hearing loss due to cochlear damage; risk is greater with prolonged use.c e g

Do not use otic preparations in patients with perforated tympanic membranes.c e g

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions possible;a b c d e g h i j anaphylaxis reported rarely.a b d h If hypersensitivity reaction occurs, discontinue the drug.a b c d e g h

Ophthalmic preparations: Neomycin sensitivity may manifest as pruritus, erythema, and edema of the conjunctiva and eyelid or as failure to heal.a b d h

Otic preparations: Neomycin sensitivity may manifest as erythema, swelling, dry scaling, and pruritus or as failure to heal.c e

Cross-allergenicity occurs among the aminoglycosides; patients who experience neomycin sensitivity also may be sensitive to kanamycin, paromomycin, streptomycin, and possibly gentamicin.a b c d f g h

Sulfite Sensitivity

Some formulations contain sulfites, which may 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 c f

General Precautions

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.b c g h If superinfection occurs, discontinue the drug and institute appropriate therapy.b g h

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 suppress hypersensitivity reactions to ingredients in the formulation.d h i j m

When neomycin is used in fixed combination with other agents (corticosteroid, other anti-infectives), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).a b c d h i j

Specific Populations

Pregnancy

Category C.a b c d g h i j

Lactation

For preparations containing neomycin in fixed combination with other anti-infectives: Caution advised.b l

For ophthalmic preparations containing neomycin in fixed combination with hydrocortisone: Manufacturers recommend discontinuing nursing or the drug.a d

For ophthalmic preparations containing neomycin in fixed combination with dexamethasone or prednisolone: Caution when used in nursing women.h i j

For otic preparations containing neomycin in fixed combination with corticosteroids: Caution advised.c e g k

Pediatric Use

Ophthalmic preparations: Safety and efficacy not established.a b d h i j

Otic preparations in fixed combination with polymyxin B sulfate and hydrocortisone: Safety and efficacy not established in children <2 years of age.c e g

Geriatric Use

Ophthalmic preparations: No overall differences in safety or efficacy relative to younger patients.a h i

Otic preparations: Insufficient clinical trial experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response.c e g

Common Adverse Effects

Ophthalmic administration: Pruritus, swelling, conjunctival erythema.a b

Otic administration: Local irritation.c g

Neomycin Sulfate Pharmacokinetics

Absorption

Bioavailability

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

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

Distribution

Extent

Not known whether topical neomycin is distributed into human milk.b l

Stability

Storage

Ophthalmic

Ointment

Neomycin and polymyxin B sulfates and bacitracin zinc: Tightly closed containers at 15–25°C.l

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

Neomycin and polymyxin B sulfates and dexamethasone: 2–25°C.i

Solution

Neomycin and polymyxin B sulfates and gramicidin: Tightly closed containers at 15–25°C; protect from light.b

Suspension

Neomycin and polymyxin B sulfates and dexamethasone: 8–27°C.j

Neomycin and polymyxin B sulfates and hydrocortisone: 20–25°C.a

Neomycin and polymyxin B sulfates and prednisolone acetate: Tightly closed containers at 15–25°C.h Store in upright position; protect from freezing.h

Otic

Solution

Neomycin and polymyxin B sulfates and hydrocortisone: 15–25°C.c

Suspension

Neomycin and colistin sulfates and hydrocortisone acetate: 20–25°C.k

Neomycin and polymyxin B sulfates and hydrocortisone: 15–25°C.e g

Actions and Spectrum

  • Usually bactericidal.f

  • Appears to inhibit protein synthesisb k l in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.f

  • Spectrum of activity includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.a b c d f

  • Inactive against fungi, viruses, and most anaerobic bacteria.f

  • Gram-positive aerobes: Active against Staphylococcus aureus and S. epidermidis.f Most streptococci are resistant.f

  • Gram-negative aerobes: Active against Enterobacter, Escherichia coli, Haemophilus influenzae, Klebsiella, Neisseria, Moraxella lacunata, and Proteus.f Inactive against Serratia marcescens and Pseudomonas aeruginosa.f

Advice to Patients

  • Importance of discontinuing therapy and consulting clinician if condition worsens or does not improve or if signs of sensitivity occur (redness, swelling, itching).a b c d g h k

  • Advise patients to immediately consult clinician regarding continued use of ophthalmic preparations if another eye condition (e.g., trauma, infection) occurs.f

  • Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.a b c d g h Advise patient to keep container tightly closed when not in use.a b h

  • Importance of not wearing contact lenses in the presence of signs and symptoms of an eye infection.h i When an ophthalmic preparation that contains benzalkonium chloride is used, importance of removing soft contact lenses prior to administering a dose and for at least 15 minutes after administration.f

  • Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a b c d g

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b c d g

  • Importance of informing patients of other important precautionary information.a b c d g (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Colistin and Neomycin Sulfates and Hydrocortisone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Otic

Suspension

Colistin Sulfate 0.3% (of colistin), Neomycin Sulfate 0.33% (of neomycin), and Hydrocortisone Acetate 1%

Coly-Mycin S Otic with Neomycin and Hydrocortisone (with thimerosal and thonzonium bromide)

JHP

Cortisporin-TC (with thimerosal and thonzonium bromide)

JHP

* 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 Ophthalmic Ointment

Akorn, Fougera

Neosporin Ophthalmic Ointment

Monarch

* 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, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%*

Cortisporin Ophthalmic Ointment

Monarch

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

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 Ophthalmic Ointment

Akorn, Fougera

* 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 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Dexamethasone 0.1%*

Maxitrol (with parabens)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment

Akorn, Bausch & Lomb, Falcon, Fougera

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Dexamethasone 0.1%*

Maxitrol (with benzalkonium chloride; viscous)

Alcon

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension

Bausch & Lomb, Falcon

* 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 0.175% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Gramicidin 0.0025%*

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution

Bausch & Lomb, United Research

Neosporin Ophthalmic Solution (with alcohol 0.5%, propylene glycol, and thimerosal)

Monarch

* 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 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%

Cortisporin Ophthalmic Suspension (with propylene glycol and thimerosal)

Monarch

Otic

Solution

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Cortisporin Otic Solution (with potassium metabisulfite and propylene glycol)

Monarch

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution

Falcon

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Hydrocortisone 1%*

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension

Falcon

Pediotic Suspension (with propylene glycol and thimerosal)

Monarch

Neomycin and Polymyxin B Sulfates and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Prednisolone Acetate 0.5%

Poly-Pred (with propylene glycol and thimerosal; viscous)

Allergan

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. Monarch. Cortisporin ophthalmic suspension sterile (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension, USP) prescribing information. Bristol, TN; 2003 Jul.

102. Monarch. Neosporin ophthalmic solution sterile (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

103. Monarch. Cortisporin otic solution sterile (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

111. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. [PubMed 6604672]

112. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. [IDIS 185969] [PubMed 6716628]

113. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. [IDIS 185966] [PubMed 6716626]

114. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. [IDIS 158261] [PubMed 7120631]

115. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. [IDIS 146240] [PubMed 7334982]

116. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. [IDIS 178793] [PubMed 6630799]

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.

a. Falcon Pharmaceuticals, Ltd. Neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension prescribing information. Fort Worth, TX; 2006 Mar.

b. Monarch Pharmaceuticals, Inc. Neosporin (neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

c. Monarch Pharmaceuticals, Inc. Cortisporin (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) prescribing information. Bristol, TN; 2003 Apr.

d. E. Fougera & Co. Neomycin and polymyxin B sulfates and bacitracin zincwith hydrocortisone acetate) ophthalmic ointment sterile prescribing information. Melville, NY; 2004 Aug.

e. Monarch Pharmaceuticals, Inc. Pediotic (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) prescribing information. Bristol, TN; 2003 Apr.

f. AHFS drug information 2008. McEvoy GK, ed. Neomycin sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2848-50.

g. Falcon Pharmaceuticals, Ltd. Neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP prescribing information. Fort Worth, TX; 2007 Jun.

h. Allergan, Inc. Poly-Pred (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) prescribing information. Irvine, CA; 2004 Dec.

i. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

j. Alcon Laboratories, Inc. Maxitrol (neomycin and polymyxin B sulfates, and dexamethasone) ophthalmic suspension prescribing information. Fort Worth, TX; 2003 Aug.

k. JHP Pharmaceuticals, LLC. Coly-Mycin S (colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone) otic suspension prescribing information. Rochester, MI; 2008 Feb.

l. E. Fougera & Co. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment prescribing information. Melville, NY; 2004 Jul.

m. 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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