Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Colistin

Colistin (polymyxin E)

Polymyxin (IV, inhaled)

CREMDRNephrotoxic

Indication

CRE bacteremia/VAP combinations β€’ MDR Pseudomonas inhaled CF/HAP

At a glance

INDICATIONS (CORE USE)

**Last-line** MDR gram-negative (CRE, carbapenem-resistant Pseudomonas) β€” **nephrotoxicity**; **dosing units chaos** (colistin base vs CMS) β€” **pharmacy mandatory**.

ADULT DOSE (STANDARD)

IV: million IU / mg CMS β€” **never guess** β€” pharmacy nomogram

MAX DOSE

Toxicity-driven β€” renal adjustment non-negotiable

Route

IV, inhaled

PEDIATRIC DOSE

Specialist + pharmacy

Do not miss

Must-not-miss safety points

Major warning

- **Nephrotoxicity** near-universal vigilance - **Neurotoxicity** apnea with NMB/sedation stacks - **Dosing errors** between products/units β€” fatal - Inhaled vs IV indications different

Indications

USE IF: MDR gram-negative infection with documented susceptibility as part of combination + ID. AVOID IF: Susceptible carbapenem available; monotherapy bacteremia empiric.

Primary

  • Carbapenem-resistant Enterobacterales infection as combination component with second in vitro active agent
  • Carbapenem-resistant Pseudomonas aeruginosa regimens β€” specialist

Secondary

  • Inhaled colistin adjunct VAP/HAP MDR β€” protocol-driven
  • CF chronic inhaled MDR pseudomonas

Other

  • Synergy laboratory only β€” never rely on monotherapy CRE bacteremia

Dosing

STANDARD (ADULT PO)

IV dose in **million IU / mg CMS** β€” pharmacy nomogram only (never guess units)

ADULT DOSE

IV loading/maintenance per CMS IU nomogram β€” institution table only

PEDIATRIC DOSE

Per pediatric MDR protocol.

MAX DOSE

Renal adjustment lowers exposure β€” toxicity still occurs

Practical Note

Never co-administer curare-like neuromuscular blockade without ventilator control.

Warnings

Clinical warnings

  • Apnea
  • Renal failure

Adverse effects

  • nephrotoxicity
  • neurotoxicity
  • inhaled bronchospasm

Contraindications

  • Myasthenia gravis relative absolute

Drug interactions

  • Aminoglycosides β€” nephro stack
  • NMB agents
  • vancomycin

Special populations

Pediatrics

Specialist + pharmacy

Pregnancy

Human data poor β€” use only if no alternative

Lactation

unknown.

Renal impairment

**Mandatory** dose reduction; HD adjustment. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ pharmacy CMS / institutional nomogram (often reduced vs conventional) - **CrCl 10–50** β†’ aggressive **↓ dose / extend interval** β€” pharmacy - **CrCl <10** / **HD** β†’ **mandatory** pharmacy dosing; **HD** session redosing per protocol

Hepatic impairment

No major guidance.

Elderly

AKI common baseline.

Administration

IV slow; inhaled with bronchodilator pretreatment.

Monitoring

  • Monitor: - **Creatinine daily** + urine output β†’ rising with aminoglycoside / vancomycin stack β†’ nephrotoxicity - Sedation + NMB β†’ **ventilatory monitoring** (apnea risk with colistin) - Creatinine daily - Urine output - Ventilator synchrony if NMB - Combination partner active on MIC
  • Recheck: - No clinical improvement at 48–72h β†’ reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **AKI** / **apnea** (NMB stack); **severe neurotoxicity**. **Secondary:** paresthesias.

Immediate Actions

Stop β†’ BMP; ventilatory support if weak/apneic; avoid NMB co-use unless controlled ICU

Antidote

No specific antidote; treat complications (e.g. anaphylaxis β†’ epinephrine per ACLS)

Decontamination

N/A

Escalation

Dialysis-requiring AKI, respiratory failure β†’ **ICU** + nephrology; **hemodialysis** may clear colistin β€” redose per protocol

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**Hail Mary** for **CRE/MDR GNR**. **Pharmacy owns the math** β€” units kill people. **Kidneys** pay the bill.

Clinical pearls

Infection control + stewardship bundle mandatory. Newer agents (ceftazidime-avibactam etc.) may supersede when susceptible. Document two active agents when possible. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • Pharmacy dose
  • Combo therapy
  • Creatinine daily

Pharmacokinetics

Renal elimination; poor lung penetration IV β€” inhaled for airway

Mechanism of action

Cationic detergent β€” disrupts outer membrane of gram-negatives.

Common brand names

Global data (no country-specific data available)

Saudi Arabia

(placeholder β€” verify local formulary)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Empiric choice β†’ tie to syndrome, severity, and local antibiogram β€” not habit.
  • IV β†’ PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness β€” stewardship.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling

Do not miss

  • Uncomplicated viral URI/bronchitis β†’ antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • Monotherapy CRE bacteremia β†’ death + resistance amplification.
  • NMB + colistin + deep sedation β†’ apnea.
  • Pharmacy dose
  • Combo therapy
  • Creatinine daily