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Drug ReportsColistimethate
Coly-mycin m, Colobreathe(colistimethate)
Colistimethate, Colobreathe, Coly-mycin M (colistimethate) is an unknown pharmaceutical. Colistimethate was first approved as Coly-mycin m on 1982-01-01. It is used to treat bacterial infections, escherichia coli infections, klebsiella infections, pseudomonas infections, and urinary tract infections in the USA. It has been approved in Europe to treat cystic fibrosis.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Colistimethate, Coly-mycin m
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Colistimethate sodium
Tradename
Company
Number
Date
Products
COLY-MYCIN MEndoN-050108 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
colistimethateANDA2024-08-29
colistimethate sodiumANDA2024-08-16
coly-mycinNew Drug Application2024-10-15
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA10: Colistin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01X: Other antibacterials in atc
— J01XB: Polymyxins
— J01XB01: Colistin
HCPCS
Code
Description
J0770
Injection, colistimethate sodium, up to 150 mg
S0142
Colistimethate sodium, inhalation solution administered through dme, concentrated form, per mg
Clinical
Clinical Trials
106 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106—151561034
InfectionsD007239EFO_0000544—218101030
Ventilator-associated pneumoniaD053717EFO_1001865J95.851—6122319
Communicable diseasesD003141————77418
SepsisD018805HP_0100806A41.91144312
BacteremiaD016470EFO_0003033R78.811242512
Bacterial infectionsD001424—A491127111
Cystic fibrosisD003550EFO_0000390E841134110
FibrosisD005355——1123—7
Critical illnessD016638——1—2317
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial pneumoniaD018410EFO_1001272J15.9—14—16
Healthy volunteers/patients———1—3——4
Iatrogenic diseaseD007049———11——2
BronchitisD001991—J40——1—12
Acute kidney injuryD058186HP_0001919N17——1—12
BronchiectasisD001987HP_0002110J47——2——2
NeoplasmsD009369—C80—11——1
Covid-19D000086382————1——1
CoinfectionD060085————1——1
Esophageal neoplasmsD004938—C15——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pseudomonas infectionsD011552EFO_0001076A41.5211——13
Pseudomonas aeruginosaD011550NCBITaxon_287——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191———12
OsteomyelitisD010019EFO_0003102M861————1
Pneumococcal infectionsD011008EFO_0000772J131————1
Disease resistanceD060467——1————1
Gram-negative bacteriaD006090——1————1
Brain diseasesD001927HP_0001298G93.401————1
Hepatic encephalopathyD006501—K72.911————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Escherichia coli infectionsD004927EFO_1001318B96.20————11
PeritonitisD010538EFO_0008588K65————11
Klebsiella pneumoniaeD007711NCBITaxon_573—————11
Neurotoxicity syndromesD020258—G92————11
DiseaseD004194EFO_0000408R69————11
ToxemiaD014115——————11
Molecular diagnostic techniquesD025202——————11
Asymptomatic infectionsD058345——————11
Microbial drug resistanceD004352——————11
Respiratory aspirationD053120EFO_1001839—————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameColistimethate
INNcolistimethate sodium
Description
Colistin, also known as polymyxin E, is an antibiotic medication used as a last-resort treatment for multidrug-resistant Gram-negative infections including pneumonia. These may involve bacteria such as Pseudomonas aeruginosa, Klebsiella pneumoniae, or Acinetobacter. It comes in two forms: colistimethate sodium can be injected into a vein, injected into a muscle, or inhaled, and colistin sulfate is mainly applied to the skin or taken by mouth. Colistimethate sodium is a prodrug; it is produced by the reaction of colistin with formaldehyde and sodium bisulfite, which leads to the addition of a sulfomethyl group to the primary amines of colistin. Colistimethate sodium is less toxic than colistin when administered parenterally. In aqueous solutions it undergoes hydrolysis to form a complex mixture of partially sulfomethylated derivatives, as well as colistin. Resistance to colistin began to appear as of 2015.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCC(C)CCCCC(=O)N(CS(=O)(=O)O)[C@@H](CCNCS(=O)(=O)O)C(=O)N[C@@H](CN[C@@H](CCNCS(=O)(=O)O)C(=O)N[C@H]1CCNC(=O)[C@H]([C@@H](C)O)NC(=O)[C@@H](CCNCS(=O)(=O)O)NC(=O)[C@H](CCNCS(=O)(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CCNCS(=O)(=O)O)NC1=O)[C@@H](C)O
Identifiers
PDB—
CAS-ID8068-28-8
RxCUI—
ChEMBL IDCHEMBL2304327
ChEBI ID—
PubChem CID5311054
DrugBankDB01111
UNII IDXW0E5YS77G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Colistimethate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 33,146 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,326 adverse events reported
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