Last reviewed · How we verify
COLISTIMETHATE
Colistimethate is a marketed drug used for treating acute or chronic infections, positioning it as a critical option in the antimicrobial arsenal. Its key strength lies in its mechanism of action, which remains effective against multidrug-resistant pathogens. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | COLISTIMETHATE |
|---|---|
| Phase | FDA-approved |
| First approval | 1970 |
Approved indications
- Acute or Chronic Infections
- Infections Due to Pseudomonas aeruginosa
- Infections Due to Specific Gram-Negative Organisms
- Serious Infections Suspected to be Due to Gram-Negative Organisms
Common side effects
- Gastrointestinal upset
- Tingling of extremities and tongue
- Paresthesia
- Dizziness
- Generalized itching
- Rash
- Urticaria
- Fever
- Slurred speech
- Vertigo
Serious adverse events
- Anaphylaxis
- Seizures
- Nephrotoxicity
- Apnea
- Respiratory distress
- Pseudo-Bartter syndrome
- Decreased creatinine clearance
- Elevated creatinine
- Increased blood urea nitrogen (BUN)
- Decreased urine output
Drug interactions
- aminoglycosides
- polymyxin
- curariform muscle relaxants (e.g., tubocurarine)
- ether
- succinylcholine
- gallamine
- decamethonium
- sodium citrate
- sodium cephalothin
Key clinical trials
- Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia (PHASE2, PHASE3)
- Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis (PHASE2)
- Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial (NA)
- Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection (NA)
- Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline (PHASE4)
- Comparing Tigecycline Vs. Colistimethate in CNS Infections
- Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection (PHASE4)
- Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- COLISTIMETHATE CI brief — competitive landscape report
- COLISTIMETHATE updates RSS · CI watch RSS