Overview
Polymyxin B was discovered in the 1940s. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa. Polymyxin B has a narrow therapeutic index and so its use is limited and unlikely to be used first line.
Background
Polymyxin B was discovered in the 1940s. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa. Polymyxin B has a narrow therapeutic index and so its use is limited and unlikely to be used first line.
Indication
Polymyxin B is indicated for the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.
Associated Conditions
- Acute Otitis Media (AOM)
- Bacteremia caused by Enterobacter aerogenes
- Bacterial Conjunctivitis
- Bacterial Infections
- Chronic Otitis Media
- Escherichia urinary tract infection
- Klebsiella bacteraemia
- Meningitis caused by Haemophilus influenzae
- Meningitis, Bacterial
- Ocular Inflammation
- Otitis Externa
- Otorrhoea
- Superficial ocular infections of the conjunctiva caused by susceptible bacteria
- Superficial ocular infections of the cornea caused by susceptible bacteria
- Urinary Tract Infection
- Ocular bacterial infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | N/A | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2022/05/04 | Phase 1 | Completed | TTY Biopharm | ||
2019/05/15 | Early Phase 1 | UNKNOWN | Shanghai 10th People's Hospital | ||
2018/10/23 | Phase 2 | UNKNOWN | |||
2017/05/18 | Phase 3 | UNKNOWN | |||
2014/12/31 | Phase 4 | UNKNOWN | |||
2014/05/08 | Phase 2 | Withdrawn | Tan Tock Seng Hospital | ||
2012/05/31 | Not Applicable | Completed | |||
2009/10/06 | Not Applicable | Withdrawn | Fraser Health | ||
2008/06/12 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 53217-305 | OPHTHALMIC | 10000 [USP'U] in 1 mL | 5/23/2018 | |
| MWI | 13985-608 | OPHTHALMIC | 10000 [USP'U] in 1 g | 3/23/2015 | |
| Aidarex Pharmaceuticals LLC | 33261-551 | OPHTHALMIC | 10000 [USP'U] in 1 mL | 8/14/2018 | |
| RPK Pharmaceuticals, Inc. | 53002-8620 | OPHTHALMIC | 10000 [USP'U] in 1 mL | 2/4/2020 | |
| STAT RX LLC USA | 16590-233 | OPHTHALMIC | 10000 1 in 1 mL | 11/18/2010 | |
| Bausch & Lomb Incorporated | 24208-780 | OPHTHALMIC | 10000 [USP'U] in 1 g | 6/30/2023 | |
| DIRECT RX | 61919-113 | OPHTHALMIC | 10000 [USP'U] in 1 g | 1/21/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-4229 | AURICULAR (OTIC) | 10000 [USP'U] in 1 mL | 6/16/2023 | |
| Physicians Total Care, Inc. | 54868-1070 | OPHTHALMIC | 10000 [USP'U] in 1 mL | 6/1/2012 | |
| Trifecta Pharmaceuticals USA | 69396-061 | TOPICAL | 10000 [USP'U] in 100 g | 5/12/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TERRAMYCIN OPHTHALMIC OINTMENT | SIN09695P | OINTMENT | 10000 iu/g | 4/6/1998 | |
| POLYDEXA EAR DROPS | SIN04945P | SOLUTION | 1000000 iu/100 ml | 7/16/1990 | |
| POLYGYNAX VAGINAL CAPSULE | SIN07745P | CAPSULE | 35000 iu | 6/15/1994 | |
| MAXITROL STERILE OPHTHALMIC SUSPENSION | SIN04358P | SOLUTION | 6000 iu/ml | 5/2/1990 | |
| POLYBAMYCIN OINT. | SIN04413P | OINTMENT | 5000 u/g | 5/3/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Polymyxini B Sulphas for Injection | 国药准字HJ20250039 | 化学药品 | 注射剂 | 4/8/2025 | |
| Polymyxini B Sulphas for Injection | 国药准字H31022631 | 化学药品 | 注射剂（冻干） | 11/26/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| POLYDEXA EAR SOLUTION-DROPS | N/A | N/A | N/A | 9/5/1998 | |
| MEVODEX EYE OINTMENT | N/A | N/A | N/A | 10/22/2024 | |
| MAXITROL OPHTH SUSP | N/A | N/A | N/A | 2/5/1982 | |
| MAXITROL OPHTH OINT | N/A | N/A | N/A | 3/10/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||