XYLISTIN 2MIU

XYLISTIN 2 MIU is a sterile, lyophilized powder containing colistimethate sodium, a polymyxin-class antibiotic. Each vial provides 2 million international units (MIU) for intravenous (IV) or intramuscular (IM) administration. It is specifically formulated for treating severe infections caused by multidrug-resistant (MDR) Gram-negative bacteria.

Composition

• Active ingredient: Colistimethate sodium equivalent to 2 MIU colistin base activity per vial

• Excipients: Sodium hydroxide for pH adjustment

Mechanism of Action

1. Binds to lipopolysaccharides in outer bacterial membrane

2. Disrupts membrane integrity through detergent-like action

3. Causes leakage of intracellular components leading to cell death

4. Exhibits concentration-dependent bactericidal activity

Dosage and Administration

Adult Dosage:

• Loading dose: 4-6 MIU (2-3 vials) divided into 2 doses

• Maintenance: 2 MIU every 12 hours IV/IM

• Maximum: 6 MIU/day in divided doses

Renal Impairment Adjustment:

• CrCl 30-50 mL/min: 1 MIU every 12 hours

• CrCl 10-30 mL/min: 1 MIU every 24 hours

• CrCl <10 mL/min: 0.5 MIU every 24 hours

Administration:

• IV: Reconstitute with 2 mL sterile water, then dilute in 50 mL NS

• Infuse over 30-60 minutes

• IM: Deep injection (may be painful)

Indications

• Ventilator-associated pneumonia (VAP)

• Bloodstream infections/sepsis

• Complicated urinary tract infections

• Wound infections

• Meningitis (off-label intrathecal use)

Storage Conditions

• Unreconstituted: 2-8°C (refrigerate)

• Reconstituted solution:

  • Stable for 24 hours at 2-8°C

  • Use immediately if stored at room temperature

• Do not freeze

Recommendations

1. Monitor renal function (SCr, BUN) every 2-3 days

2. Assess neurological status regularly

3. Avoid concurrent nephrotoxic drugs

4. Consider therapeutic drug monitoring

5. Use ideal body weight for dosing in obese patients

Important Notes

Contraindications:

• Hypersensitivity to polymyxins

• Myasthenia gravis

Warnings:

• Nephrotoxicity (up to 50% incidence)

• Neurotoxicity (paresthesia, neuromuscular blockade)

• Apnea (with rapid IV infusion)

• Superinfections possible

Side Effects: Common (≥1%):

• Acute kidney injury

• Neuropathy

• Diarrhea

• Injection site pain

Serious:

• Anaphylaxis

• Seizures

• Respiratory paralysis

Drug Interactions:

• Enhanced nephrotoxicity with aminoglycosides

• Neuromuscular blockade with anesthetics

• Increased neurotoxicity with corticosteroids

Pregnancy Category: C

• Use only if potential benefit justifies risk

Presentation:

• Single-dose vial containing 2 MIU

• Pack of 1 vial per box

Note:

• Reserve for confirmed MDR Gram-negative infections

• Consider combination therapy for CRE infections

• Dosage adjustments mandatory in renal impairment

• Not for intrathecal use unless specifically indicated