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Cortisporin (POLYMYXIN B)
Cortisporin (POLYMYXIN B) is a polymyxin-class antibacterial small molecule developed by Monarch Pharms in 1957. It is used to treat various bacterial infections, including conjunctivitis, keratitis, septicemia, and meningitis. Cortisporin is off-patent and has multiple generic manufacturers. As a polymyxin-class antibacterial, it works by disrupting bacterial cell membranes. Key safety considerations include potential nephrotoxicity and ototoxicity.
At a glance
| Generic name | POLYMYXIN B |
|---|---|
| Sponsor | Pfizer |
| Drug class | Polymyxin-class Antibacterial |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1957 |
Approved indications
- Bacterial conjunctivitis
- Bacterial keratitis
- Bacterial septicemia
- Blepharoconjunctivitis
- Corneal abrasion
- H. Influenzae Meningitis
- Infective blepharitis
- Keratitis
- Mastoidectomy Cavity Infections
- Minor Bacterial Skin Infections
- Minor Skin Wound Pain
- Otitis externa
- Superficial Ocular Infection
- Urinary tract infectious disease
- Uveitis
Common side effects
- Allergic contact dermatitis
- Itching
- Burning
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Maceration of the skin
- Secondary infection
Serious adverse events
- Ototoxicity
- Nephrotoxicity
Key clinical trials
- Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis (NA)
- A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
- Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE2)
- Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study (NA)
- To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects (PHASE1)
- Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE3)
- Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
- Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cortisporin CI brief — competitive landscape report
- Cortisporin updates RSS · CI watch RSS
- Pfizer portfolio CI