1. Clinical & Scientific Overview
Polymyxin B Sulfate (TIP-MED-000532, Reference Code [R-13]) is classified under
Reserve Antimicrobials (WHO AWaRe Reserve) as a Cationic Cyclic Lipopeptide Reserve Antibiotic.
Within the Indian regulatory and compendial framework, it is governed under Schedule H1 Reserve Antibiotic (Drugs Rules, 1945).
Poly-B (Samrath Life Sciences), Criticare Polymyxin B (Cipla Ltd), Malimyxin (Macleods Pharmaceuticals)
Lyophilised Powder for IV Infusion: 500,000 IU (50 mg) vial
Statutory Restriction, High-Alert & Dispensing Safeguards
Indian Regulatory & Statutory Control Basis: Schedule H1 Reserve Antibiotic (Drugs Rules, 1945)
High-Alert Clinical Risk, Dependence & Narrow Therapeutic Index Warnings: Dose-limiting acute tubular necrosis (nephrotoxicity in 20–50% of patients) and neuromuscular blockade/paresthesias; Unlike Colistimethate Sodium (CMS), Polymyxin B is administered as the active moiety and cleared predominantly by non-renal pathways (preferable for bloodstream infections).
Mandatory Dispensing Register & Institutional Custody Protocol: Restricted hospital antimicrobial stewardship sign-off required; calculate loading dose (25,000 IU/kg) + maintenance (12,500–15,000 IU/kg q12h) using total body weight; avoid concomitant aminoglycosides or vancomycin if possible.
3. Mechanism of Action & Pharmacodynamics
Binds electrostatically to lipid A of lipopolysaccharide (LPS) in the outer membrane of Gram-negative bacteria, displacing divalent cations (Ca2+, Mg2+) and disrupting membrane permeability.
4. Therapeutic Indications & Evidence-Supported Uses
- Life-threatening carbapenem-resistant Acinetobacter baumannii (CRAB), Pseudomonas aeruginosa, and Klebsiella pneumoniae infections
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Specialist-Supervised Educational Reference Summary: Dosing of Polymyxin B must be individualised by a qualified specialist according to clinical indication, organ function, and institutional protocol (Lyophilised Powder for IV Infusion: 500,000 IU (50 mg) vial).
Administration & Meal Timing: Routes: Intravenous Infusion, Intrathecal/Intraventricular, Nebulised. Restricted hospital antimicrobial stewardship sign-off required; calculate loading dose (25,000 IU/kg) + maintenance (12,500–15,000 IU/kg q12h) using total body weight; avoid concomitant aminoglycosides or vancomycin if possible.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Exhibits cationic cyclic lipopeptide reserve antibiotic pharmacokinetic disposition; verify baseline renal and hepatic clearance and check for active or prolonged-half-life metabolites before repeat dosing.
Hepatic Phase I (CYP450) and/or Phase II conjugation or specific non-renal clearance as detailed in clinical warnings.
Verify eGFR / CrCl before initiation; see specific metabolite and renal clearance notes above.
Assess baseline Child-Pugh status and hepatic transaminases prior to therapy.
7. Contraindications, Precautions & High-Risk Warnings
- Known severe hypersensitivity to Polymyxin B or formulation excipients
- Unsupervised outpatient self-administration or dispensing without mandatory statutory prescription verification
- Specific clinical contraindications detailed under High-Alert Warnings & Statutory Restrictions
Key Clinical Precautions: Dose-limiting acute tubular necrosis (nephrotoxicity in 20–50% of patients) and neuromuscular blockade/paresthesias; Unlike Colistimethate Sodium (CMS), Polymyxin B is administered as the active moiety and cleared predominantly by non-renal pathways (preferable for bloodstream infections).
8. Adverse Effects Profile
- Dose-limiting acute tubular necrosis (nephrotoxicity in 20–50% of patients) and neuromuscular blockade/paresthesias; Unlike Colistimethate Sodium (CMS), Polymyxin B is administered as the active moiety and cleared predominantly by non-renal pathways (preferable for bloodstream infections).
- Dose-dependent target-organ pharmacodynamic effects requiring clinical observation
- Dose-limiting acute tubular necrosis (nephrotoxicity in 20–50% of patients) and neuromuscular blockade/paresthesias; Unlike Colistimethate Sodium (CMS), Polymyxin B is administered as the active moiety and cleared predominantly by non-renal pathways (preferable for bloodstream infections).
- High-alert toxicity, dependence/diversion risk, or severe organ-specific adverse events if administered outside protocol
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Dose-limiting acute tubular necrosis (nephrotoxicity in 20–50% of patients) and neuromuscular blockade/paresthesias; Unlike Colistimethate Sodium (CMS), Polymyxin B is administered as the active moiety and cleared predominantly by non-renal pathways (preferable for bloodstream infections).
- Review all concomitant CNS depressants, QTc-prolonging agents, nephrotoxins, or CYP450 modulators prior to dispensing.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Restricted hospital antimicrobial stewardship sign-off required; calculate loading dose (25,000 IU/kg) + maintenance (12,500–15,000 IU/kg q12h) using total body weight; avoid concomitant aminoglycosides or vancomycin if possible.
Pharmacist Patient Counselling Points:
- Restricted hospital antimicrobial stewardship sign-off required; calculate loading dose (25,000 IU/kg) + maintenance (12,500–15,000 IU/kg q12h) using total body weight; avoid concomitant aminoglycosides or vancomycin if possible.
- Must be used strictly under direct medical supervision; never share prescription medicines or alter the prescribed dose.
Storage, Stability & Dispensing Safeguards: Restricted hospital antimicrobial stewardship sign-off required; calculate loading dose (25,000 IU/kg) + maintenance (12,500–15,000 IU/kg q12h) using total body weight; avoid concomitant aminoglycosides or vancomycin if possible.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Drugs and Cosmetics Act, 1940 & Rules, 1945 (Schedule H / H1 / X); NDPS Act, 1985 & Essential Narcotic Drugs (END) Notification; Indian Pharmacopoeia (IP) & National Formulary of India (NFI).
Official Verification Portals: CDSCO — Drugs & Cosmetics Act and Rules (Schedules H, H1, X) • Department of Revenue — Narcotic Drugs and Psychotropic Substances (NDPS) Act • Indian Pharmacopoeia Commission (IPC) — National Formulary of India
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
💊 Related Pharmacological / Category Profiles
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- [R-15] Ceftazidime + Avibactam — 3rd-Generation Cephalosporin + Non-Beta-Lactam Diazabicyclooctane
- [R-16] Meropenem + Vaborbactam — Carbapenem + Cyclic Boronic Acid Beta-Lactamase Inhibitor
- [R-17] Cefiderocol — Siderophore Cephalosporin ('Trojan Horse' Reserve Antibiotic)
