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Overview
Polymyxin B is an anti-bacterial agent that is FDA approved for the treatment of infections of the urinary tract, meninges, and bloodstream and used subconjunctivally in the treatment of infections of the eye caused by susceptible strains of P. aeruginosa.. Common adverse reactions include facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa
Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of P. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of P. aeruginosa.
It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosing Information
Parenteral
Intravenous
Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5% for continuous drip.
Adults and children: 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.
Intramuscular
Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 polymyxin B units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%.
Adults and children: 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.
Intrathecal
A treatment of choice for P. aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL sodium chloride injection, USP for 50,000 units per mL dosage unit.
Adults and children over 2 years of age: Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.
Topical
Ophthalmic: Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.
For the treatment of P. aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.
Subconjunctival injection of up to 100,000 units/day may be used for the treatment of P. aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
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There is limited information regarding Off-Label Guideline-Supported Use of Polymyxin B in adult patients.
Non–Guideline-Supported Use
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Polymyxin B in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Parenteral
Intravenous
Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5% for continuous drip.
Adults and children: 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.
Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Intramuscular
Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 polymyxin B units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%.
Adults and children: 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.
Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by P aeruginosa.
Intrathecal
A treatment of choice for P. aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL sodium chloride injection, USP for 50,000 units per mL dosage unit.
Adults and children over 2 years of age: Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
Children under 2 years of age: 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.
Topical
Ophthalmic: Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.
For the treatment of P. aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.
Subconjunctival injection of up to 100,000 units/day may be used for the treatment of P. aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Polymyxin B in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
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Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Polymyxin B in pediatric patients.
Non–Guideline-Supported Use
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Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Polymyxin B in pediatric patients.
Contraindications
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Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Polymyxin B in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Polymyxin B in the drug label.