Description
Colistimethate Sodium Injection
Healthy Inc is a specialized global supplier and exporter of life-saving “Last Resort” antibiotics. We provide high-purity Colistimethate Sodium Injection (1 MIU / 2 MIU / 3 MIU / 4.5 MIU), sourced from WHO–GMP certified sterile injectable facilities. This “MDR Terminator” is a top export to intensive care units (ICU), cystic fibrosis centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the final line of defense against multi-drug resistant (MDR) Gram-negative superbugs like *Acinetobacter baumannii*, *Pseudomonas aeruginosa*, and Carbapenem-Resistant *Enterobacteriaceae* (CRE).
Product Overview
This formulation contains Colistimethate Sodium (CMS), an inactive prodrug that is hydrolyzed in the body to the active antibiotic Colistin (Polymyxin E).
The “Membrane Buster” Specialist:
- Mechanism (The “Detergent” Effect): Active Colistin acts like a cationic detergent. It binds to the negatively charged Lipopolysaccharides (LPS) and phospholipids on the outer membrane of Gram-negative bacteria. It displaces calcium and magnesium ions, destabilizing the membrane and causing it to leak cell contents, leading to rapid bacterial death.
- MDR & XDR Activity: It is one of the few drugs effective against “Pan-Resistant” organisms that are resistant to all Cephalosporins, Carbapenems, and Fluoroquinolones. It is the backbone of salvage therapy for VAP (Ventilator-Associated Pneumonia) and Sepsis caused by superbugs.
- Inhalation Therapy: It can be nebulized to treat lung infections in Cystic Fibrosis patients, delivering high local concentrations with reduced systemic toxicity.
Product Composition & Strength
We supply this product as a Sterile Lyophilized Powder for Injection in glass vials. Strength is measured in International Units (IU).
| Strength (IU) | Approximate Mass (mg) | Colistin Base Activity (CBA) |
|---|---|---|
| 1 MIU (1 Million IU) | ~80 mg CMS | ~34 mg CBA |
| 2 MIU | ~160 mg CMS | ~68 mg CBA |
| 3 MIU | ~240 mg CMS | ~100 mg CBA |
| 4.5 MIU | ~360 mg CMS | ~150 mg CBA |
| Excipients | None (Pure Powder) | – |
*Pack Sizes: Tray of 1 Vial, 10 Vials, or Box of 1/10 Vials.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.19 (Medicaments containing other antibiotics) |
| Dosage Form | Lyophilized Powder (Reconstitute immediately before use) |
| Packaging | Type I Glass Vial (Sterile) with Flip-off Seal |
| Storage | Store below 25°C. Protect from Light. Reconstituted solution must be used immediately (hydrolyses rapidly). |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Prodrug Stabilization: Colistimethate is chemically unstable and can prematurely hydrolyze into toxic Colistin if exposed to moisture. We use advanced lyophilization cycles to ensure near-zero moisture content, preventing nephrotoxicity from developing in the vial during storage.
- Endotoxin Control: Given its use in critically ill patients (sepsis), our manufacturing process ensures endotoxin levels are well below pharmacopeial limits to prevent pyrogenic reactions.
Therapeutic Indications (Human Use)
Indicated for the treatment of life-threatening infections caused by MDR Gram-negative bacteria:
- Ventilator-Associated Pneumonia (VAP): Caused by Acinetobacter baumannii or Pseudomonas aeruginosa.
- Complicated UTIs: Caused by Carbapenem-Resistant Klebsiella pneumoniae.
- Cystic Fibrosis: Inhalation therapy for chronic Pseudomonas lung infection.
- Bacteremia / Sepsis: As salvage therapy when all other antibiotics fail.
Dosage & Administration
Recommended Dosage (Strictly as per Critical Care Specialist):
- Route: Intravenous (IV) Infusion or Inhalation (Nebulization).
- Loading Dose (Critical): 9 MIU IV once (to reach therapeutic levels rapidly).
- Maintenance Dose (Normal Renal Function): 4.5 MIU every 12 hours (Total 9 MIU/day).
- Renal Impairment: Dose adjustment is MANDATORY. (e.g., 2.25 MIU every 12h or 24h depending on CrCl).
- Inhalation (CF): 1-2 MIU twice daily via nebulizer.
- Reconstitution: Dissolve gently (do not shake vigorously to avoid foaming) in Normal Saline or WFI.
Safety Warnings (CRITICAL):
- Nephrotoxicity (Kidney Damage): Occurs in 30-50% of patients. Active Colistin is directly toxic to renal tubules. Monitor Creatinine daily. Stop other nephrotoxic drugs (Aminoglycosides, NSAIDs).
- Neurotoxicity: Can cause dizziness, facial paresthesia (tingling), slurred speech, and neuromuscular blockade (respiratory paralysis). Monitor for apnea.
- Bronchospasm: Inhalation can cause chest tightness. Pre-treat with bronchodilators if needed.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
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