SEO PLR Content Directory Georgia: February 2012

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

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 SpectrumActions

Usually bactericidal.^f

Appears to inhibit protein synthesis^b ^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