What is the recommended dilution for acetyl cysteine (N-acetylcysteine) injection?

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Acetylcysteine Injection Dilution

For intravenous administration of acetylcysteine, dilute the 20% inhalational solution to a 2.6% concentration by adding 150 mL of 20% N-acetylcysteine to 1 liter of 5% dextrose in water (D5W), filtered through a 22-micron filter. 1

Standard Dilution Protocol

The recommended dilution creates a final concentration of approximately 30 grams of N-acetylcysteine in 1 liter of D5W, which is stable for up to 60 hours at room temperature. 2, 1

Preparation Steps

  • Use the 20% inhalational N-acetylcysteine solution (200 mg/mL) as the source product 1
  • Add 150 mL of the 20% solution through a 22-micron filter into 1 liter of D5W 1
  • This creates a 2.6% solution (approximately 30 g/L) suitable for intravenous administration 2, 1
  • The solution remains chemically stable for at least 60 hours at ambient conditions (25°C, 65% relative humidity) 1

Dosing Regimen Using This Dilution

The standard three-bag FDA-approved regimen can be simplified using a single-bag preparation:

  • Loading dose: 150 mg/kg administered over 1 hour 2
  • Maintenance infusion: 14 mg/kg/hour for 20 hours 2
  • Total treatment duration is typically 21 hours, though may be extended based on clinical parameters 2

Alternative FDA-Approved Regimen

For reference, the traditional three-bag FDA regimen uses different dilutions 3:

  • Bag 1: Loading dose of 150 mg/kg in 200 mL D5W over 60 minutes
  • Bag 2: 50 mg/kg in 500 mL D5W over 4 hours
  • Bag 3: 100 mg/kg in 1000 mL D5W over 16 hours

Stability and Safety Considerations

The diluted solution meets USP standards for stability, sterility, and pyrogen-free status when properly prepared:

  • Chemical stability is maintained with <10% decomposition for 60 hours at room temperature 1
  • At 72 hours, degradation reaches 10-15%, exceeding acceptable limits 1
  • Solutions remain free from bacterial growth for at least 72 hours 1
  • Endotoxin/pyrogen testing is negative when prepared under sterile technique 1

Critical Preparation Pitfalls to Avoid

  • Do not use solutions older than 60 hours - degradation exceeds acceptable limits after this timepoint 1
  • Always use a 22-micron filter during preparation to ensure sterility 1
  • Maintain sterile technique throughout preparation to prevent contamination 4
  • Do not dilute in normal saline - D5W is the appropriate diluent 2, 1

Dosing Adjustments for Massive Overdose

For patients with acetaminophen concentrations above the "300-line" on the Rumack-Matthew nomogram, consider increasing the maintenance infusion rate:

  • Standard maintenance: 14 mg/kg/hour 2
  • For massive overdoses (>300-line): stepwise increases in dosing may be necessary 5
  • Patients above the 300-line develop hepatotoxicity at higher rates and may benefit from dose escalation 5

Monitoring During Administration

Key parameters to monitor include:

  • Hepatic transaminases (AST/ALT) - hepatotoxicity defined as AST >1000 units/L 6, 2
  • Serum acetaminophen concentrations 6
  • Infusion-related adverse reactions occur in approximately 6% of patients but rarely require discontinuation 6
  • Mean duration of therapy is 25.6 hours, with mean length of stay 2.99 days 2

Common Administration Errors

The simplified single-bag protocol reduces but does not eliminate medication errors 2:

  • Loading dose rate errors are most common (11 rate-related errors per study) 2
  • Dose-related errors occur less frequently (8 per study) 2
  • Therapy interruptions >60 minutes are rare (occurred in only 3/70 patients) 2

Clinical Efficacy

All patients with hepatotoxicity (AST >1000 units/L) due to acute acetaminophen toxicity had complete resolution and successful discharge when treated with this protocol. 2

  • The simplified regimen is effective and well-tolerated 2
  • Intravenous administration offers advantages over oral including shorter hospital stay, patient convenience, and avoidance of reduced bioavailability from charcoal or vomiting 6
  • Meta-analysis shows similar outcomes between IV and oral routes when treatment is initiated within 24 hours 6

References

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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