Paracetamol 100 mL Formulation and Mannitol Content
Yes, intravenous paracetamol 100 mL formulations contain mannitol as an excipient, specifically 3.91 g of mannitol per 100 mL vial. 1
Formulation Details
The standard IV paracetamol preparation contains:
This formulation is used for intravenous administration in clinical settings, including perioperative pain management and acute pain control.
Clinical Relevance of Mannitol Content
The mannitol content in IV paracetamol is generally well-tolerated and does not produce clinically significant osmotic effects at standard dosing. 1
Hemodynamic Safety
- A randomized controlled trial in patients with chronic liver disease undergoing liver transplantation demonstrated that IV paracetamol (containing 3.91 g mannitol per 100 mL) produced no significant hemodynamic changes compared to placebo 1
- No differences were observed in blood pressure or other hemodynamic parameters 30 minutes post-infusion 1
- This is particularly reassuring given that patients with chronic liver disease are highly susceptible to hemodynamic derangements due to their low systemic vascular resistance 1
Dosing Considerations
- Maximum single dose for adults: 1000 mg (1 g) 2
- Maximum daily dose: 4000 mg (4 g) in 24 hours 2
- For chronic use, consider limiting to 3000 mg or less per day to reduce hepatotoxicity risk 3
Important Caveats
The mannitol in IV paracetamol formulations should not be confused with therapeutic mannitol used for intracranial pressure management. The 3.91 g of mannitol per 100 mL vial serves as a pharmaceutical excipient and does not provide clinically meaningful osmotic diuresis or ICP reduction 1. Therapeutic mannitol for elevated ICP is administered at much higher doses (0.25-1 g/kg) 4 and should be discontinued when serum osmolality exceeds 320 mOsm/L 5.