Polymyxin B
Loading...Polymyxin B Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Polymyxin B for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. 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:
H influenzae, specifically meningeal infections.
Escherichia coli, specifically urinary tract infections.
Aerobacter aerogenes, specifically bacteremia.
Klebsiella pneumoniae, specifically bacteremia.
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 susceptible 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.
History
There is currently no drug history available for this drug.
Other Information
Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Polymyxin B sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). The chemical name of polymyxin B sulfate is N-[4-amino-1-[[1-[[4-amino-1-oxo-1-[[6,9,18-tris(2-aminoethyl)-15-benzyl-3-(1-hydroxyethyl)-12-(2-methylpropyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptazacyclotricos-21-yl]amino]butan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxobutan-2-yl]-6-methyloctanamide; sulfuric acid. It has a potency of not less than 6000 polymyxin B units per mg, calculated on the anhydrous basis. The structural formulae are:
Each vial contains Polymyxin B Sulfate equivalent to 500,000 polymyxin B units for parenteral or ophthalmic administration.
Polymyxin B for Injection, USP is a white to almost white colored powder suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.
In the medical literature, dosages have frequently been given in terms of equivalent weights of pure polymyxin B base. Each milligram of pure polymyxin B base is equivalent to 10,000 units of polymyxin B and each microgram of pure polymyxin B base is equivalent to 10 units of polymyxin B.
Aqueous solutions of polymyxin B sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Polymyxin B sulfate should not be stored in alkaline solutions since they are less stable.
Sources
Polymyxin B Manufacturers
-
Sagent Pharmaceuticals
![Polymyxin B (Polymyxin B Sulfate) Injection, Powder, For Solution [Sagent Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Polymyxin B | Sagent Pharmaceuticals
PARENTERAL:Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL of 5% Dextrose Injection for continuous intravenous 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 0.9% 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 Ps aeruginosa.
Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL 0.9% Sodium Chloride Injection 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 0.9% Sodium Chloride Injection for a 10,000 to 25,000 units per mL concentration.
For the treatment of Ps 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 per day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
-
X-gen Pharmaceuticals, Inc.
Polymyxin B | X-gen Pharmaceuticals, Inc.
PARENTERAL:
Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent 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 percent.
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 Ps aeruginosa.
Intrathecal. A treatment of choice for Ps 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 Ps 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 Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
-
X-gen Pharmaceuticals, Inc.
Polymyxin B | X-gen Pharmaceuticals, Inc.
PARENTERAL:
Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent 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 percent.
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 Ps aeruginosa.
Intrathecal. A treatment of choice for Ps 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 Ps 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 Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
-
X-gen Pharmaceuticals, Inc.
Polymyxin B | X-gen Pharmaceuticals, Inc.
PARENTERAL:
Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent 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 percent.
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 Ps aeruginosa.
Intrathecal. A treatment of choice for Ps 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 Ps 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 Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
-
Fresenius Kabi Usa, Llc
Polymyxin B | Fresenius Kabi Usa, Llc
Parenteral
IntravenousDissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral 5% Dextrose Injection 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 0.9% 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 Ps aeruginosa.
Intrathecal
A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 polymyxin B units in 10 mL 0.9% 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 Ps 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 Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
![Polymyxin B Injection, Powder, Lyophilized, For Solution [X-gen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=caeee003-cfdc-4b57-a88b-5391ed7e73e5&name=polymyxin-b-for-injection-usp-2.jpg)
![Polymyxin B Injection, Powder, Lyophilized, For Solution [X-gen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=805caef0-89df-4bcf-876d-9f6b7a89c9a3&name=polymyxin-b-for-injection---usp-2.jpg)
![Polymyxin B Injection, Powder, Lyophilized, For Solution [X-gen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a14373aa-c5fa-4f90-8e8f-fc9e2219039c&name=polymyxin-b-for-injection-usp-2.jpg)
![Polymyxin B (Polymyxin B Sulfate) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
Login To Your Free Account