1.

Generic name: polymyxin b Sulfate

2. Brand name : Poly - RX
2. Drug class : Antibiotic, Anti-Infective Agent
3. Introduction
Polymyxin B injection is used to treat bacterial infections in many different parts of the body.
Polymyxin B belongs to the group of medicines known as antibiotics. It works by killing
bacteria or preventing their growth. However, this medicine will not work for colds, flu, or
other virus infections.
4. Mechanism of action
Polymyxin B sulfate is a basic polypeptide antibiotic that has bactericidal activity against
nearly all strains of gram-negative bacilli, except those of the Proteus group. It exerts its
effect by increasing bacterial cell membrane permeability leading to death of the cell. It is not
effective against gram-positive bacteria, fungi, or gram-negative cocci.
5. Indication
Infections of the urinary tract due to E. coli
Meninges
Bacterial Septicemia due to P. aeruginosa,
It may also be used topically and subconjunctivally in the treatment of infections of the eye
caused by susceptible strains of Ps.
6. Dose and Administration
6.1. Adult
Systemic Infections
IV: 15,000-25,000 units/kg/day divided q12hr; not to exceed 25,000 units/kg/day
IM: 25,000-30,000 units/kg/day divided q4-6hr
Intrathecal: 50,000 qDay for 3-4 days; then qDay or qODay for at least 2 weeks after CSF
cultures are negative and normal for glucose content
Total daily dose not to exceed 2,000,000 units/day
Renal Impairment
CrCl >20 mL/minute: give 75-100% usual dose/day divided q12hr
CrCl 5-20 mL/minute: give 50% usual dose/day divided q12hr
CrCl <5 mL/minute: give 15% usual dose/day q12hr
Bacteremia
IM: 25,000 to 30,000 units/kg/day IM divided every 4 or 6 hours
IV: 15,000 to 25,000 units/kg/day IV divided every 12 hours
Recommended as the drug of choice in the treatment of infections due to susceptible strains
of Pseudomonas aeruginosa.
Meningitis
Initial dose: 50,000 units intrathecally once a day for 3 to 4 days
Maintenance dose: 50,000 units intrathecally every other day
Duration of therapy: At least 2 weeks after CSF cultures are negative and sugar content
normalizes.
Ocular Infection
Ophthalmic:
Topical: Instill 1 to 3 drops into the affected eye(s) every hour, increasing intervals as
indicated by response
Subconjunctival injection: Inject up to 100,000 units/day subconjunctivally
A concentration of 0.1% to 0.25% (10,000 to 25,000 units/mL) is recommended for topical
use.
Total systemic and ophthalmic instillation over 25,000 units/kg/day should be avoided.
6.2. Pediatric
Systemic Infections
Infants
IM: May receive up to 40,000 units/kg/day divided q6hr if renal function healthy
IV: May receive up to 40,000 units/kg/day divided q12hr;
Intrathecal: 20,000 units/day for 3-4 days; follow with 25,000 units qODay for at least 2
weeks after CSF cultures are negative and CSF (glucose) has returned to normal
Children
IM: 25,000-30,000 units/kg/day divided q12hr
IV: 15,000-25,000 units/kg/day divided q12hr; not to exceed 25,000 units/kg/day
Intrathecal: 50,000 qDay for 3-4 days; then qDay or qODay for at least 2 weeks after CSF
cultures are negative and normal for glucose content
Renal Impairment
CrCl >20 mL/min: give 75-100% usual dose/day divided q12hr
CrCl 5-20 mL/min: give 50% usual dose/day divided q12hr
CrCl <5 mL/min: give 15% usual dose/day q12hr
Bacteremia
Infants:
IM: 25,000 to 40,000 units/kg/day IM divided every 4 or 6 hours
IV: 15,000 to 40,000 units/kg/day IV divided every 12 hours

Children:
IM: 25,000 to 30,000 units/kg/day IM divided every 4 or 6 hours
IV: 15,000 to 25,000 units/kg/day IV divided every 12 hours
Sepsis
Infants
IM: 25,000 to 40,000 units/kg/day IM divided every 4 or 6 hours
IV: 15,000 to 40,000 units/kg/day IV divided every 12 hours
Children:
IM: 25,000 to 30,000 units/kg/day IM divided every 4 or 6 hours
IV: 15,000 to 25,000 units/kg/day IV divided every 12 hours
Meningitis
Children under 2 years:
Initial dose: 20,000 units intrathecally once a day for 3 to 4 days OR 25,000 units
intrathecally every other day
Maintenance dose: 25,000 units intrathecally every other day
Children over 2 years
Initial dose: 50,000 units intrathecally once a day for 3 to 4 days
Maintenance dose: 50,000 units intrathecally every other day
Duration of therapy: At least 2 weeks after CSF cultures are negative and sugar content
normalizes

7. Pharmacokinetics and dynamic

Absorption
Tmax, IM: 2 hours
Bioavailability, Oral: 0%
Distribution
Protein binding: 78.5% to 92.4%, critically ill subjects; 55.9%, healthy subjects
Vd: 71 to 194 mL/kg
Excretion

Renal: 0.04% to 4.04% unchanged [9][10]

Renal clearance: 0.00032 to 0.0039 mL/min/kg [10]; 0.061 L/hr
Dialyzable (continuous venovenous hemodialysis):
Total body clearance: 0.27 to 0.81 mL/min/kg; 0.0276 L/hr/kg [9]; 2 to 2.5 L/hr (patients
with and without renal insufficiency)
Elimination Half Life: 6 hours
8. Contraindications
History of hypersensitivity reactions to polymyxins
allogeneic cultured keratinocytes/fibroblasts in bovine collagen
9. Precautions
Concomitant use
Avoid use with a curariform muscle relaxant and other neurotoxic drugs (eg, tubocurarine,
succinylcholine, gallamine, decamethonium and sodium citrate), which may precipitate
respiratory depression; discontinue use if suspected.
Gastrointestinal
Polymyxin B injection may cause diarrhea, and in some cases it can be severe. It may occur 2
months or more after you stop using this medicine. Do not take any medicine to treat diarrhea
without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or
make it last longer.
Immunologic: Overgrowth of nonsusceptible organisms such as fungi or superinfection may
occur; treatment may be required.
10. Adverse Effects
Common
Gastrointestinal: Diarrhea
Serious
Gastrointestinal: Clostridium difficile diarrhea
Neurologic: Neurotoxicity
Renal: Acute injury of kidney (34.5% to 46.1% ), Renal failure (Up to 14.6% )
Respiratory: Respiratory tract paralysis
Anaphylactoid reactions with dyspnea and tachycardia
Eosinophilia
Fever
Nephrotoxicity
Neurotoxicity
Skin exanthemata
Urticaria
11. Black Box Warning
Intramuscular (Powder for Solution)
Polymyxin B sulfate should be given only to hospitalized patients when administered IM
and/or intrathecally. Therapy has been associated with potential neurotoxicity and
nephrotoxicity. Monitor renal function during therapy and reduce dose in patients with renal
impairment. Concurrent use of other neurotoxic or nephrotoxic agents should be avoided.
Neuromuscular blockade and respiratory paralysis can occur following administration,
especially when the drug is given soon after anesthesia and/or muscle relaxants. The safety of
this drug in pregnancy has not been established 14.
Intrathecal (Powder for Solution)
Polymyxin B sulfate should be given only to hospitalized patients when administered IM
and/or intrathecally. Therapy has been associated with potential neurotoxicity and
nephrotoxicity. Monitor renal function during therapy and reduce dose in patients with renal
impairment. Concurrent use of other neurotoxic or nephrotoxic agents should be avoided.
Neuromuscular blockade and respiratory paralysis can occur following administration,
especially when the drug is given soon after anesthesia and/or muscle relaxants. The safety of
this drug in pregnancy has not been established 14.
Intravenous (Powder for Solution)
Polymyxin B sulfate should be given only to hospitalized patients when administered IM
and/or intrathecally. Therapy has been associated with potential neurotoxicity and
nephrotoxicity. Monitor renal function during therapy and reduce dose in patients with renal
impairment. Concurrent use of other neurotoxic or nephrotoxic agents should be avoided.
Neuromuscular blockade and respiratory paralysis can occur following administration,
especially when the drug is given soon after anesthesia and/or muscle relaxants. The safety of
this drug in pregnancy has not been established 14.
12. Drug Interactions
Major Interactions
Alcuronium
Atracurium
Cisatracurium
Doxacurium
Fazadinium
Gallamine
Hexafluorenium
Metocurine
Mivacurium
Pancuronium
Pipecuronium
Rapacuronium
Rocuronium
Tubocurarine
Vecuronium
13. Pregnancy and Lactation
Pregnancy Category: B: use when benefits outweigh risks
Lactation: use caution; Infant risk cannot be ruled out.Weigh the potential benefits against
the potential risks before taking this medication while breastfeeding.
14. Stability
Storage requirements
Before reconstitution: Store at 20C to 25C (68F to 77F); store in carton until use to protect
from light.
After reconstitution: Store in refrigerator between 2C and 8C (36F and 46F) up to 72 hours.
Disposal
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless
you are told to do so. Check with your pharmacist if you have questions about the best way to
throw out drugs. There may be drug take-back programs in your area.
15. Others considerations
Advise patients that antibacterials (including polymyxin B) should only be used to treat
bacterial infections and not used to treat viral infections (e.g., the common cold).
Importance of completing full course of therapy, even if feeling better after a few days.
Advise patients that skipping doses or not completing the full course of therapy may decrease
effectiveness and increase the likelihood that bacteria will develop resistance and will not be
treatable with polymyxin B or other antibacterials in the future.

Reference

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