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.
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
Research Report
Polymyxin B: A Comprehensive Monograph on a Last-Resort Antibiotic
Section 1: Introduction and Pharmaceutical Profile
1.1. Overview: The Resurgence of a Legacy Antibiotic
Polymyxin B is a polypeptide antibiotic belonging to the polymyxin class, a group of agents that also includes the clinically significant polymyxin E, or colistin.[1] The history of Polymyxin B is a compelling narrative of discovery, disuse, and reluctant revival. It was first discovered in the 1940s, isolated from the soil bacterium Paenibacillus polymyxa (previously known as Bacillus polymyxa), and introduced into clinical practice in the 1950s.[4] However, by the 1970s and 1980s, its use for systemic infections had sharply declined. This was a direct result of its significant potential for inducing severe nephrotoxicity (kidney damage) and neurotoxicity (nerve damage), coupled with the concurrent development and introduction of safer and better-tolerated antibiotic classes, such as the aminoglycosides and broad-spectrum beta-lactams.[7]
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 | |
| Rite Aid Corporation | 11822-2700 | TOPICAL | 10000 [USP'U] in 1 g | 9/9/2025 | |
| 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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ANTIBIOTIC OINTMENT USP | 02230251 | Ointment - Topical | 10000 UNIT / G | 6/10/2002 | |
| PULMOSIRUM PASTILLE | nutribon (1986) inc. | 01912461 | Lozenge - Oral | 1500 UNIT / LOZ | 12/31/1994 |
| ANTIBIOTIC CREAM | cellchem pharmaceuticals inc. | 02311844 | Cream - Topical | 10000 UNIT / G | 12/23/2009 |
| TRIPLE ANTIBIOTIC OINTMENT | cellchem pharmaceuticals inc. | 02297949 | Ointment - Topical | 10000 UNIT / G | 12/23/2009 |
| POLY ANTIBIOTIC OINTMENT | the avon company canada limited | 02510383 | Ointment - Topical | 10000 UNIT / G | 3/3/2021 |
| ANTIBIOTIC COLD SORE OINTMENT | columbia laboratories canada inc | 01910914 | Ointment - Topical | 500 UNIT / G | 12/31/1992 |
| LANABIOTIC ONT | 00611328 | Ointment - Topical | 5000 UNIT / G | 12/31/1984 | |
| CORTISPORIN | 01912828 | Solution - Otic | 10000 UNIT / ML | 12/31/1991 | |
| ANTIBIOTIC OINTMENT | canadian custom packaging company | 02372037 | Ointment - Topical | 10000 UNIT / G | 5/16/2012 |
| POLYDERM ANTIBIOTIC OINTMENT | pharmetics (2011) inc | 00758213 | Ointment - Topical | 10000 UNIT / G | 12/31/1989 |
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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