Should polymyxin (e.g., polymyxin B or colistin) be stored refrigerated at 2–8 °C?

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Polymyxin Storage Requirements

Yes, reconstituted polymyxin B must be refrigerated at 2–8°C (36–46°F) and discarded after 72 hours. This is a critical safety requirement specified in the FDA-approved drug labeling 1.

Storage Guidelines by Preparation Stage

Unreconstituted Vials

  • Store at room temperature: 20–25°C (68–77°F)
  • Protect from light
  • Keep in original carton until use 1

After Reconstitution (Critical)

Refrigeration is mandatory 1:

  • Temperature: 2–8°C (36–46°F)
  • Maximum storage: 72 hours
  • Discard any unused portion after this period

The FDA labeling explicitly states: "IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS" 1.

Stability Data Supporting Refrigeration

Research confirms polymyxin B stability is temperature-dependent 2:

  • At 4°C (refrigerated): Retains >90% potency for at least 24 hours
  • At 25°C (room temperature): Also retains >90% potency for 24 hours, but refrigeration is still mandated by FDA labeling

The decomposition follows pseudo-first-order kinetics with rate constants of 0.022–0.043 day⁻¹ at 4°C versus 0.024–0.075 day⁻¹ at 25°C 2.

Important Distinction: Colistin vs Polymyxin B

Note that colistin (colistimethate sodium) has different stability characteristics 3:

  • Can be stored refrigerated for 7 days plus 1 day at room temperature
  • Shows increased hydrolysis to active colistin over time (1.5% initially to 2.1–2.6% after 8 days)

However, this does not apply to polymyxin B, which must follow the stricter 72-hour refrigerated storage requirement 1.

Clinical Pitfalls to Avoid

  • Never use polymyxin B solutions stored at room temperature beyond what's needed for immediate administration
  • Do not confuse storage requirements between colistin and polymyxin B—they are different drugs with different stability profiles
  • Always date and time reconstituted vials to ensure the 72-hour limit is not exceeded
  • Designate a medication-only refrigerator—do not store with food or specimens 4

References

Research

Stability of polymyxin B sulfate diluted in 0.9% sodium chloride injection and stored at 4 or 25 degrees C.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2010

Research

Colistin methanesulfonate infusion solutions are stable over time and suitable for home administration.

European journal of hospital pharmacy : science and practice, 2018

Guideline

allergen immunotherapy: a practice parameter second update.

Journal of Allergy and Clinical Immunology, 2007

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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