Polymyxin B Sulfate eent

Class: Antibacterials
VA Class: OT101
CAS Number: 1405-20-5
Brands: AK-Poly-Bac, Cortisporin, Maxitrol, Neosporin, Pediotic, Poly-Pred, Polytrim

Introduction

Antibacterial; polymyxin antibiotic produced by Bacillus polymyxa.a b c d f g h k l

Uses for Polymyxin B Sulfate

Bacterial Ophthalmic Infections

Used in fixed combination with other anti-infectives (e.g., bacitracin, neomycin, gramicidin, trimethoprim) for treatment of superficial infections of the eye caused by susceptible bacteria.b e k l

Used in fixed combination with corticosteroids and other anti-infectives in certain bacterial ocular infections.a d h i j

Not indicated for treatment or prophylaxis of ophthalmic neonatorum.e

Bacterial Otic Infections

Used in fixed combination with corticosteroids (with or without other anti-infectives) for treatment of otitis externa caused by susceptible bacteria.c f g

Polymyxin B Sulfate Dosage and Administration

Administration

Apply topically to the eye or ear.a b c d e f g h i j k l

Ophthalmic Administration

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

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

Avoid contamination of the preparation container.a b h l

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 corticosteroids (with or without other anti-infectives), instill into the external ear as an otic solution or suspension.c f g

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

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

Shake suspension well prior to each use.g

Use sparingly to prevent an accumulation of excess debris in the ear canal.f

Dosage

Potency and dosage of polymyxin B sulfate are expressed in terms of polymyxin B activity.f

Pediatric Patients

Bacterial Ophthalmic Infections
Polymyxin B Sulfate and Trimethoprim Sulfate
Ophthalmic Solution

Infants and children ≥2 months of age, mild-to-moderate infections: 1 drop into the affected eye(s) every 3 hours, up to 6 doses daily, for 7–10 days.e

Bacterial Otic Infections
Polymyxin B and Neomycin 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 g

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

Adults

Bacterial Ophthalmic Infections
Polymyxin B and Neomycin 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

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

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

Polymyxin B and Neomycin 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 drops 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

Polymyxin B and Neomycin 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

Polymyxin B and Neomycin Sulfates and Hydrocortisone
Ophthalmic Suspension

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

Polymyxin B and Neomycin Sulfates and Prednisolone Acetate
Ophthalmic Suspension

1 or 2 drops into the affected eye(s) every 3–4 hours, or more frequently, as required.h For acute infection, 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 or 4 hours.h (See Administration under Dosage and Administration.)

Polymyxin B Sulfate and Bacitracin Zinc
Ophthalmic Ointment

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

Polymyxin B Sulfate and Trimethoprim Sulfate
Ophthalmic Solution

1 drop into the affected eye(s) every 3 hours, up to 6 doses daily, for 7–10 days.e

Bacterial Otic Infections
Polymyxin B and Neomycin 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 g

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

Prescribing Limits

Pediatric Patients

Bacterial Ophthalmic Infections
Polymyxin B Sulfate and Trimethoprim Sulfate:
Ophthalmic Solution

Infants and children ≥2 months of age: Maximum 6 doses in 24 hours.e

Bacterial Otic Infections
Polymyxin B and Neomycin Sulfates and Hydrocortisone
Otic Solution or Suspension

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

Adults

Bacterial Ophthalmic Infections
Polymyxin B Sulfate and Trimethoprim Sulfate
Ophthalmic Solution

Maximum 6 doses in 24 hours.e

Bacterial Otic Infections
Polymyxin B and Neomycin Sulfates and Hydrocortisone
Otic Solution or Suspension

Maximum 10 consecutive days of therapy.c g

Special Populations

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

Cautions for Polymyxin B Sulfate

Contraindications

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

Warnings/Precautions

Warnings

Administration

Do not use otic preparations in any patient with a perforated tympanic membrane.c g

Ophthalmic Ointments

Ophthalmic ointments may delay corneal healing.f k l

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions possible (e.g., rash, itching, reddening, conjunctival and eyelid edema);b c d anaphylaxis reported rarely.a b d h If hypersensitivity occurs, discontinue the drug.a b c d g

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

General Precautions

Superinfection

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

When polymyxin B is used in fixed combination with other agents (corticosteroids, other anti-infectives), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).a b c d e h l

Specific Populations

Pregnancy

In fixed combination with other agents (corticosteroids, other anti-infectives): Category C.a b c d e g h l

Lactation

Ophthalmic preparations in fixed combination with other anti-infectives: Caution advised.b e h l

Ophthalmic preparations in fixed combination with other anti-infectives and hydrocortisone: Discontinue nursing or the drug.a d

Ophthalmic preparations in fixed combination with other anti-infectives and dexamethasone: Caution advised.i

Otic preparations in fixed combination with other anti-infectives and corticosteroids: Caution advised.c g

Pediatric Use

Safety and efficacy of trimethoprim sulfate and polymyxin B ophthalmic solution not established in infants <2 months of age.e

Safety and efficacy of neomycin and polymyxin B sulfates and hydrocortisone otic solution and suspension not established in children <2 years of age.c g

Safety and efficacy of other polymyxin B fixed-combination preparations (e.g., with corticosteroids and/or anti-infectives) not established.a b d h i j l

Geriatric Use

Ophthalmic preparations in fixed combination with other anti-infectives and hydrocortisone or prednisolone: No overall differences in safety or efficacy relative to younger patients.a d h

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment: No overall differences in safety or efficacy relative to younger patients.i

Otic preparations: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.c g

Common Adverse Effects

Local irritation.a b c d e g

Polymyxin B Sulfate Pharmacokinetics

Absorption

Bioavailability

Minimal or no absorption from intact or denuded skin or from mucous membranes.e f

Distribution

Extent

Not known whether topical polymyxin B is distributed into human milk.b e (See Bioavailability under Pharmacokinetics.)

Stability

Storage

Ophthalmic

Ointment

Polymyxin B and bacitracin zinc: 20–25°C.k

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

Polymyxin B and neomycin sulfates, bacitracin zinc, and hydrocortisone acetate: 15–25°C.d

Polymyxin B and neomycin sulfates and dexamethasone: 2–25°C.i

Solution

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

Polymyxin B sulfate and trimethoprim sulfate: 20–25°C; protect from light.e

Suspension

Polymyxin B sulfate and neomycin sulfates and dexamethasone: 8–27°C.j

Polymyxin B and neomycin sulfates and hydrocortisone: 20–25°C.a

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

Otic

Solution or Suspension

15–25°C.c g

Actions and Spectrum

  • Usually bactericidal.b e f l

  • Polymyxin B increases permeability of the bacterial cell wall membrane by interacting with the phospholipid components of the cell membrane.b e f l

  • Spectrum of activity of polymyxin B includes many aerobic gram-negative bacteria.e f k l Inactive against gram-positive bacteria and fungi.f

  • Gram-negative aerobes: Active against Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.e f

  • Neisseria and Proteus usually are resistant.f Complete cross-resistance between colistin derivatives and polymyxin B.f

Advice to Patients

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

  • 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 e g h l Advise patient to keep container tightly closed when not in use.b h l

  • Importance of not wearing contact lenses if signs and symptoms of eye infection occur.h

  • Advise patient not to share the drug with any other person.a b d e h

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

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

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

Preparations

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

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

AK-Poly-Bac

Akorn

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment

Bausch & Lomb, Fougera

Neomycin and Polymyxin B Sulfate 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%*

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

Bausch & Lomb, Fougera

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

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

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 0.35% (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

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%

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension (with propylene glycol and thimerosal)

Falcon

Otic

Solution

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

Cortisporin (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%*

Neosporin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension (with propylene glycol and thimerosal)

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

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 0.1% (of trimethoprim)

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution (with benzalkonium chloride)

Akorn

Polymyxin B Sulfate and Trimethoprim Sulfate Ophthalmic Solution

Bausch & Lomb

Polytrim (with benzalkonium chloride)

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 Pharmaceuticals, Inc. 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.

104. Bedford. Polymyxin B for injection 500,000 units prescribing information. Bedford, OH; 2004 Feb.

105. Akorn. Trimethoprim sulfate and polymyxin B sulfates ophthalmic solution prescribing information. Buffalo Grove, IL; 1998 Aug.

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. 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 prescribing information. Bristol, TN; 2003 Apr.

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

e. Akorn, Inc. Trimethoprim sulfate and polymyxin B sulfate ophthalmic solution prescribing information. Buffalo Grove, IL; 2006 Mar.

f. AHFS drug information 2008. McEvoy GK, ed. Polymyxin B sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2853-5.

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

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. Akorn Pharmaceuticals, Inc. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP prescribing information. Buffalo Grove, IL. 2007 Aug.

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

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