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European Journal of Clinical Pharmacology

, Volume 54, Issue 4, pp 367–373 | Cite as

Pharmacokinetics of tamsulosin in subjects with normal and varying degrees of impaired renal function: an open-label single-dose and multiple-dose study

  • M. Wolzt
  • V. Fabrizii
  • G. T. Dorner
  • G. Zanaschka
  • P. Leufkens
  • W. J. J. Krauwinkel
  • H.-G. Eichler
PHARMACOKINETICS AND DISPOSITION

Abstract

Objective: This study was performed to estimate whether the pharmacokinetics and safety of tamsulosin, an α1A-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia (BPH), are influenced by impaired renal function.

Methods: In an open-label study design, the plasma concentration profile of 0.4 mg tamsulosin p.o. was studied in age-matched groups of male subjects with normal (n = 10), moderately impaired (n = 10), and severely impaired (n = 8) renal function after single-dose administration and in steady state, i.e. after 21 days of multiple-dose administration.

Results: The AUC of total, but not of unbound, tamsulosin was correlated to creatinine clearance and α1-acid glycoprotein plasma levels, and was found to be significantly higher in both groups of subjects with impaired renal function than in controls after single- and multiple-dose administration. However, the pharmacokinetics of total and unbound tamsulosin were comparable for both trial periods.

Conclusions: Impaired renal function increases total tamsulosin plasma concentration by approximately 100% after single-dose administration and in steady state. Since active unbound drug levels are not affected, no dose modification is required in symptomatic BPH patients with renal impairment.

Key words Tamsulosin Benign prostatic hyperplasia 

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Copyright information

© Springer-Verlag Berlin Heidelberg 1998

Authors and Affiliations

  • M. Wolzt
    • 1
  • V. Fabrizii
    • 1
  • G. T. Dorner
    • 1
  • G. Zanaschka
    • 1
  • P. Leufkens
    • 2
  • W. J. J. Krauwinkel
    • 2
  • H.-G. Eichler
    • 1
  1. 1.Klinische Pharmakologie, Allgemeines Krankenhaus Wien, Währinger Gürtel 18-20, A-1090 Wien, Austria Tel.: +43 1 40400 2980; Fax: +43 1 40400 2998AT
  2. 2.Yamanouchi Europe, Leiderdorp, The NetherlandsNL

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