Overview
Colistimethate is an antibiotic that has been shown to have bactericidal activity against aerobic gram-negative microorganisms. Colistimethate is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa.
Indication
For the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli, particularly Pseudomonas aeruginosa.
Associated Conditions
- Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Phase 4 | Active, not recruiting | |||
2025/02/19 | Not Applicable | Recruiting | |||
2024/11/25 | N/A | Not yet recruiting | |||
2024/07/05 | Phase 2 | Not yet recruiting | |||
2024/01/10 | Phase 3 | Recruiting | |||
2022/10/19 | Phase 4 | Completed | |||
2018/01/12 | Phase 4 | Completed | National Cancer Institute, Egypt | ||
2016/11/17 | Phase 4 | Completed | Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology | ||
2015/06/26 | N/A | Completed | |||
2015/05/22 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-393 | INTRAMUSCULAR, INTRAVENOUS | 150 mg in 2 mL | 1/23/2020 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-193 | INTRAMUSCULAR, INTRAVENOUS | 150 mg in 4 mL | 7/5/2022 | |
| XGen Pharmaceuticals DJB, Inc. | 39822-0615 | INTRAMUSCULAR, INTRAVENOUS | 150 mg in 2 mL | 12/2/2022 | |
| Xellia Pharmaceuticals USA LLC | 70594-023 | INTRAMUSCULAR, INTRAVENOUS | 150 mg in 1 1 | 6/25/2020 | |
| Nexus Pharmaceuticals Inc | 14789-201 | INTRAVENOUS, INTRAMUSCULAR | 150 mg in 1 1 | 9/28/2021 | |
| Xellia Pharmaceuticals USA LLC | 70594-023 | INTRAVENOUS, INTRAMUSCULAR | 150 mg in 1 1 | 3/2/2022 | |
| Par Pharmaceutical, Inc. | 42023-107 | INTRAMUSCULAR, INTRAVENOUS | 150 mg in 2 mL | 12/10/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/13/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TADIM colistimethate sodium 1million IU powder for nebuliser solution vial | 165709 | Medicine | A | 2/2/2011 | |
| COLISTIN LINK colistimethate sodium (equivalent to colistin 150 mg, 4,500,000 IU) powder for injection vial | 14667 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 9/20/1991 |
| COLISTIMIXIN PHEBRA colistimethate sodium 1million IU powder for nebuliser solution vial | 211398 | Medicine | A | 4/2/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| COLISTIMETHATE FOR INJECTION USP | marcan pharmaceuticals inc | 02546639 | Powder For Solution - Intramuscular
,
Intravenous | 150 MG / VIAL | 6/10/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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