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Coly-mycin m, Colobreathe(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
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 MPar PharmaceuticalN-050108 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
colistimethateANDA2022-12-02
coly-mycinNew Drug Application2018-12-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
escherichia coli infectionsEFO_1001318D004927B96.20
klebsiella infectionsEFO_1001353D007710—
pseudomonas infectionsEFO_0001076D011552—
urinary tract infectionsEFO_0003103D014552N39.0
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
6 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_0003124———1—1
HyperlipidemiasD006949EFO_0003774E78.5———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I98——2——2
Coronary diseaseD003327——2——2
Coronary artery diseaseD003324I25.1——2——2
Myocardial ischemiaD017202EFO_1001375I20-I25——2——2
Heart diseasesD006331EFO_0003777I51.9——2——2
Erythropoietic protoporphyriaD046351E80.0—11——1
Cerebrovascular disordersD002561EFO_0003763I60-I69——1——1
Carotid artery diseasesD002340EFO_0003781——1——1
AtherosclerosisD050197EFO_0003914I25.1——1——1
Intracranial arteriosclerosisD002537EFO_1000860I67.2——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
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)
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-ID1066-17-7
RxCUI2709
ChEMBL IDCHEMBL2304327
ChEBI ID—
PubChem CID5311054
DrugBankDB00803
UNII IDXW0E5YS77G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,375 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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636 adverse events reported
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