Tolerance and pharmacokinetics of propacetamol, a paracetamol formulation for intravenous use

Authors:
  • AHA. van Hecken
    A. van Hecken
  • PSPj de Schepper
    Pj de Schepper
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Abstract
Summary— In 12 healthy volunteers, paracetamol pharmacokinetics were compared following administration of 1 g propacetamol HCl given intravenously over a 15‐min period and 500 mg paracetamol given orally. Mean ± SD total AUC (μg/ml·h) following the iv formulation was significantly (P < 0.01) greater than following oral paracetamol (25.53 ± 4.27 vs 21.04 ± 4.49) corresponding to a mean oral bioavailability of paracetamol of 82.2 ± 9.4%. Between 1 and 2 h after administration, paracetamol plasma concentrations became very similar following both formulations. In another study, 2 g propacetamol HCl was given both as a 15‐min infusion and as a 2‐min bolus injection to six healthy volunteers. Contrary to mild to moderate local discomfort experienced during the 2‐min bolus injection, the 15‐min infusion was well tolerated without any complaints reported.