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Single- and multiple-dose metronidazole kinetics.

J C Jensen, R Gugler

    Clinical Pharmacology and Therapeutics
    |October 1, 1983
    PubMed
    Summary
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    Metronidazole exhibits complete oral bioavailability and consistent pharmacokinetics across single and multiple doses. Its elimination is primarily through metabolism into 2-hydroxy-metronidazole and 1-acetic acid metronidazole.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacy
    • Drug Metabolism

    Background:

    • Metronidazole is a widely used antibiotic and antiprotozoal agent.
    • Understanding its pharmacokinetic profile is crucial for optimizing therapeutic efficacy and minimizing adverse effects.

    Purpose of the Study:

    • To characterize the pharmacokinetics of metronidazole and its major metabolites following single oral, single intravenous, and multiple oral doses.
    • To assess the oral bioavailability and steady-state concentrations of metronidazole.

    Main Methods:

    • Sensitive High-Performance Liquid Chromatography (HPLC) assay was employed for quantification.
    • Pharmacokinetic parameters including volume of distribution (Vd beta), plasma half-life (t1/2), and total body clearance (ClTBC) were determined.
    • Urinary excretion of metronidazole and its metabolites was analyzed.

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    Main Results:

    • Following intravenous administration, mean Vd beta was 1.05 L/kg, mean plasma t1/2 was 8.3 hr, and ClTBC was 1.31 ml/min/kg.
    • Oral bioavailability of metronidazole was complete (98.9%), with peak plasma concentrations of 6.9 µg/ml reached at 2.3 hr after a single 400 mg dose.
    • Metabolism to 2-hydroxy-metronidazole and 1-acetic acid metronidazole accounted for over 90% of total clearance, with urinary excretion of unchanged metronidazole below 10%.

    Conclusions:

    • Metronidazole demonstrates consistent pharmacokinetic behavior after single and multiple oral doses, with an elimination half-life of 8.3 hr.
    • The drug achieves complete systemic oral bioavailability and predictable steady-state concentrations.
    • Metabolism to 2-hydroxy-metronidazole and 1-acetic acid metronidazole represents the primary elimination pathway.