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Multiple-dose acetaminophen pharmacokinetics.

C G Sahajwalla¹, J W Ayres

¹College of Pharmacy, Oregon State University, Corvallis 97331-3507.

Journal of Pharmaceutical Sciences

|September 1, 1991

Summary

Acetaminophen (Tylenol) demonstrates linear pharmacokinetics at doses up to 18 mg/kg, meaning its absorption and elimination are predictable. Higher doses may show nonlinear behavior in some individuals.

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Area of Science:

Pharmacology
Clinical Pharmacy
Drug Metabolism

Background:

Acetaminophen (Tylenol) is a widely used analgesic and antipyretic.
Understanding its pharmacokinetic profile is crucial for safe and effective dosing.

Purpose of the Study:

To investigate the pharmacokinetic linearity of acetaminophen in healthy volunteers.
To determine if acetaminophen exhibits dose-dependent pharmacokinetics at various therapeutic doses.

Main Methods:

Four doses of acetaminophen (325-1000 mg) were administered to eight healthy volunteers.
Saliva concentrations were measured over time to determine pharmacokinetic parameters.
Noncompartmental analysis was used to compare parameters like AUC and half-life.

Main Results:

Acetaminophen showed linear pharmacokinetics for doses up to 18 mg/kg.
Dose-corrected AUC, half-life (t1/2), and mean residence time (MRT) were consistent across doses and administration times.
Nonlinear pharmacokinetic behavior was suggested in one subject at doses exceeding 18 mg/kg.

Conclusions:

Acetaminophen exhibits linear pharmacokinetics at doses of 18 mg/kg or less.
This linearity supports predictable dosing within this range.
Potential for nonlinear behavior at higher doses warrants further investigation.

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