XYLISTIN 4.5 MIU is a sterile, lyophilized powder for intravenous (IV) or intramuscular (IM) injection, containing Colistimethate Sodium, a polymyxin antibiotic. It is used for the treatment of severe multidrug-resistant Gram-negative infections, particularly those caused by Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae.
Composition
-
Active Ingredient:
-
Colistimethate Sodium (equivalent to 4.5 million international units [MIU] per vial).
-
-
Excipients:
-
Sodium hydroxide (for pH adjustment).
-
Mechanism of Action
-
Bactericidal action by binding to lipopolysaccharides (LPS) in the outer membrane of Gram-negative bacteria.
-
Disrupts cell membrane integrity, leading to cell lysis.
-
Effective against multi-drug resistant (MDR) Gram-negative bacteria, including:
-
Pseudomonas aeruginosa
-
Acinetobacter baumannii
-
Carbapenem-resistant Enterobacteriaceae (CRE)
-
Dosage & Administration
Adult Dose (IV/IM):
-
Loading Dose: 9 MIU (divided into 2 doses 12 hours apart).
-
Maintenance Dose: 4.5 MIU every 12 hours (adjust based on renal function).
Pediatric Dose:
-
2.5–5 MIU/kg/day in 2–4 divided doses (max 9 MIU/day).
Renal Dose Adjustment:
-
CrCl 30–50 mL/min: 3 MIU every 12 hours.
-
CrCl 10–30 mL/min: 2.25 MIU every 12 hours.
-
CrCl <10 mL/min or dialysis: 1.5 MIU every 24 hours (administer after dialysis).
Administration:
-
IV: Dilute in 50–100 mL NS/D5W, infuse over 30–60 minutes.
-
IM: Deep intramuscular injection (painful, use lidocaine if needed).
Uses (Indications)
✔ Severe pneumonia (HAP/VAP) caused by MDR Gram-negative bacteria.
✔ Bloodstream infections (sepsis) due to CRE or Pseudomonas.
✔ Complicated urinary tract infections (cUTIs).
✔ Wound infections & burn sepsis.
✔ Meningitis (intrathecal administration in some cases).
Storage
-
Unreconstituted powder: Store at 2–8°C (refrigerated).
-
Reconstituted solution:
-
Stable for 24 hours at 2–8°C (discard unused portions).
-
Do not freeze.
-
Recommendations
✔ Monitor renal function (SCr, BUN) before and during therapy.
✔ Check for neurotoxicity (tingling, dizziness, seizures).
✔ Avoid concurrent use with nephrotoxic drugs (vancomycin, aminoglycosides).
✔ Not effective against Gram-positive bacteria or anaerobes.
Important Note
Contraindications:
-
Hypersensitivity to colistin or polymyxins.
-
Myasthenia gravis (risk of neuromuscular blockade).
Side Effects:
⚠ Nephrotoxicity (acute kidney injury – monitor SCr).
⚠ Neurotoxicity (paresthesia, seizures, dizziness).
⚠ Hypersensitivity reactions (rash, anaphylaxis).
-
Injection site pain (IM route).
Drug Interactions:
-
Aminoglycosides, vancomycin, NSAIDs ↑ nephrotoxicity risk.
-
Neuromuscular blockers ↑ respiratory depression risk.
Pregnancy & Lactation:
-
Category C (use only if benefits outweigh risks).
-
Breastfeeding: Safety unknown (avoid if possible).
Presentation
-
Single-dose vial (4.5 MIU powder for reconstitution).
Reviews
There are no reviews yet.