NDAINJECTIONINJECTABLE
Approved
Jun 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
COLY-MYCIN M (colistimethate) by Pfizer is clinical pharmacology typical serum and urine levels following a single 150 mg dose of coly-mycin m parenteral im or iv in normal adult subjects are shown in figure 1. First approved in 1970.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Coly-Mycin M (colistimethate sodium) is a surface-active polymyxin antibiotic administered via injection that disrupts bacterial cell membranes. It is indicated for infections caused by aerobic gram-negative microorganisms including Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Enterobacteracter aerogenes. The drug is bactericidal and has a serum half-life of 2–3 hours with renal clearance.
LOE Approaching
Product approaching loss of exclusivity with low commercial momentum; expect a small, stable brand team focused on legacy maintenance and potential generic transition.
Mechanism of Action
CLINICAL PHARMACOLOGY Typical serum and urine levels following a single 150 mg dose of Coly-Mycin M Parenteral IM or IV in normal adult subjects are shown in Figure 1. Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2–3…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection
Started Jul 2023
80 enrolled
Mental Health Issue
Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
Started Jan 2018
287 enrolled
Non Cystic Fibrosis Bronchiectasis
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)
Started Aug 2015
50 enrolled
Bacterial Infections
Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults
Started Oct 2013
60 enrolled
Hospital-acquired Pneumonia
Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium
Started Sep 2013
16 enrolled
Colistin
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.