Finished product reference
Polymyxin B
Injection · Parenteral · 500000 U
- List code
- 1023
WARNING CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN. RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE.
Indications
INDICATIONS AND USAGE 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.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION 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.
Contraindications
CONTRAINDICATIONS This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.
Warnings and precautions
WARNINGS 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.
Storage and supply
HOW SUPPLIED Polymyxin B for Injection , USP 500,000 polymyxin B units per vial is supplied in rubber-stoppered glass vial with flip off cap, carton of 10, NDC 0143-9941-10. Storage recommendations: Before reconstitution: Store at 20° to 25°C (68° to 77°F) . Protect from light. Retain in carton until time of use.
Source: Polymyxin B Sulfate (Polymyxin B) — US FDA prescribing information, 2022-04-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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