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
Trade Name
FDA
EMA
Coly-mycin m (generic drugs available since 1999-02-26)
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 M | Par Pharmaceutical | N-050108 RX | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| colistimethate | ANDA | 2022-12-02 |
| colistimethate sodium | ANDA | 2023-10-25 |
| coly-mycin | New Drug Application | 2018-12-03 |
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
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 4 | 11 | 2 | 3 | 17 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 5 | 2 | 4 | 11 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | 3 | 5 | 1 | 11 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 2 | 4 | 1 | 4 | 9 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | 2 | 3 | 1 | — | 5 |
| Bacterial infections | D001424 | — | A49 | 1 | 1 | 2 | 1 | 1 | 5 |
| Acinetobacter infections | D000151 | EFO_1000792 | — | — | — | — | 1 | 3 | 4 |
| Critical illness | D016638 | — | — | 1 | — | 1 | 1 | — | 3 |
| Gram-negative bacterial infections | D016905 | — | — | — | — | — | 3 | — | 3 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 1 | 1 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | 1 | 2 | 3 | — | 3 | 7 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | — | 3 | — | 1 | 5 |
| Healthy volunteers/patients | — | — | — | 1 | — | 3 | — | — | 4 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | — | 1 | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | 1 | — | 1 | 2 |
| Septic shock | D012772 | — | A48.3 | — | — | 1 | — | — | 1 |
| Iatrogenic disease | D007049 | — | — | — | — | 1 | — | — | 1 |
| Bronchitis | D001991 | — | J40 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudomonas aeruginosa | D011550 | NCBITaxon_287 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudomonas infections | D011552 | EFO_0001076 | A41.52 | 1 | — | — | — | 1 | 2 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | 1 | — | — | — | — | 1 |
| Gram-negative bacteria | D006090 | — | — | 1 | — | — | — | — | 1 |
| Hepatic encephalopathy | D006501 | — | K72.91 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Klebsiella pneumoniae | D007711 | NCBITaxon_573 | B96.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Colistimethate |
| INN | colistimethate 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) |  |
| 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-ID | 8068-28-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2304327 |
| ChEBI ID | — |
| PubChem CID | 5311054 |
| DrugBank | DB01111 |
| UNII ID | XW0E5YS77G (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Colistimethate
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Trends
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Safety
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Adverse Events
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676 adverse events reported
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