XYLISTIN 1 MIU is a sterile, lyophilized powder for intravenous (IV) or intramuscular (IM) administration, containing colistimethate sodium (1 million international units [MIU] per vial). It belongs to the polymyxin class of antibiotics and is specifically used for severe infections caused by multidrug-resistant (MDR) Gram-negative bacteria, including Pseudomonas aeruginosa, Acinetobacter baumannii, and carbapenem-resistant Enterobacteriaceae (CRE).
Composition
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Active Ingredient:
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Colistimethate sodium (equivalent to 1 MIU colistin base activity per vial).
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Excipients:
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Sodium hydroxide (for pH adjustment).
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Mechanism of Action
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Bactericidal effect by binding to the lipopolysaccharide (LPS) in the outer membrane of Gram-negative bacteria.
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Disrupts cell membrane integrity, causing leakage of cellular contents and bacterial death.
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Effective against MDR strains, including:
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Carbapenem-resistant Enterobacteriaceae (CRE)
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ESBL-producing E. coli and Klebsiella
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Pan-resistant Pseudomonas and Acinetobacter
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Dosage & Administration
Standard Adult Dose (IV/IM):
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Loading Dose: 4.5–6 MIU (divided into 2 doses 12 hours apart).
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Maintenance Dose: 1.5–2 MIU every 12 hours (adjusted for renal function).
Pediatric Dose:
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2.5–5 MIU/kg/day in 2–4 divided doses (max 9 MIU/day).
Renal Dose Adjustment:
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CrCl 30–50 mL/min: 1 MIU every 12 hours.
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CrCl 10–30 mL/min: 0.5–1 MIU every 24 hours.
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CrCl <10 mL/min or dialysis: 0.5 MIU every 48 hours (post-dialysis).
Administration Guidelines:
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IV: Reconstitute with 1 mL sterile water, then dilute in 50 mL NS/D5W; infuse over 30–60 minutes.
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IM:Â Deep injection (may require lidocaine for pain).
Uses (Indications)
✔ Hospital-acquired pneumonia (HAP/VAP)
✔ Bloodstream infections (sepsis)
✔ Complicated urinary tract infections (cUTIs)
✔ Wound infections and burn sepsis
✔ Meningitis (intrathecal use in some cases)
Storage
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Unreconstituted powder: Store at 2–8°C (refrigerated); protect from light.
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Reconstituted solution:
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Stable for 24 hours at 2–8°C (discard unused portions).
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Do not freeze or shake vigorously.
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Recommendations
✔ Monitor renal function (SCr, BUN) before and during therapy.
✔ Assess for neurotoxicity (tingling, dizziness, seizures).
✔ Avoid concurrent nephrotoxic drugs (e.g., vancomycin, NSAIDs).
✔ Not effective against Gram-positive or anaerobic bacteria.
Important Note
Contraindications:
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Hypersensitivity to colistin or polymyxins.
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Myasthenia gravis (risk of neuromuscular blockade).
Side Effects:
⚠ Nephrotoxicity (↑ SCr, acute kidney injury).
⚠ Neurotoxicity (paresthesia, ataxia, seizures).
⚠ Hypersensitivity reactions (rash, anaphylaxis).
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Injection site pain (IM route).
Drug Interactions:
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Aminoglycosides/vancomycin: ↑ Nephrotoxicity.
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Neuromuscular blockers: ↑ Respiratory depression.
Pregnancy & Lactation:
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Category CÂ (use only if benefits outweigh risks).
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Breastfeeding: Avoid (unknown excretion in milk).
Presentation
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Single-dose vial (1 MIU powder for reconstitution).
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