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Loratadine: multiple-dose pharmacokinetics.

E Radwanski1, J Hilbert, S Symchowicz

  • 1Department of Drug Metabolism and Pharmacokinetics, Schering Corporation, Bloomfield, NJ 07003.

Journal of Clinical Pharmacology
|July 1, 1987
PubMed
Summary
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This study shows that loratadine (L) and its active metabolite descarboethoxyloratadine (DCL) accumulate minimally with daily dosing. Steady-state pharmacokinetics confirm predictable drug levels for this long-acting antihistamine.

Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Drug Metabolism

Background:

  • Loratadine (L) is a novel, long-acting antihistamine without central nervous system (CNS) activity.
  • Understanding the steady-state pharmacokinetics of L is crucial for establishing effective and safe dosing regimens.

Purpose of the Study:

  • To investigate the steady-state pharmacokinetics of loratadine (L) and its active metabolite, descarboethoxyloratadine (DCL).
  • To evaluate drug accumulation following multiple once-daily doses of loratadine.

Main Methods:

  • 12 healthy male volunteers received 40 mg loratadine (L) capsules every 24 hours for 10 days.
  • Plasma concentrations of L and DCL were measured using radioimmunoassay (RIA) and high-performance liquid chromatography (HPLC), respectively.
  • Pharmacokinetic parameters were determined by fitting concentration-time data to a biexponential equation.

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Main Results:

  • Steady-state peak plasma concentrations (Cmax) for L and DCL were achieved rapidly.
  • Area under the curve (AUC tau) values at steady state were determined for both L and DCL.
  • Accumulation indexes (Ra) for L and DCL were low (1.4 and 1.9, respectively) after the fifth dose, indicating minimal accumulation.

Conclusions:

  • Loratadine (L) and its active metabolite (DCL) exhibit minimal accumulation with a once-daily dosage regimen.
  • The steady-state pharmacokinetic profile of loratadine is predictable and consistent with single-dose administration.
  • These findings support the safety and efficacy of loratadine for long-term use as an antihistamine.