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Related Experiment Videos

Fluvoxamine affects sildenafil kinetics and dynamics.

Christiane Hesse1, Heike Siedler, Jürgen Burhenne

  • 1Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.

Journal of Clinical Psychopharmacology
|November 12, 2005
PubMed
Summary
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Fluvoxamine, an antidepressant, moderately increases sildenafil exposure and vascular effects in men. This interaction suggests a potential need for a lower starting dose of sildenafil when used with fluvoxamine.

Area of Science:

  • Pharmacology
  • Drug Interactions
  • Clinical Pharmacology

Background:

  • Sildenafil, an oral treatment for erectile dysfunction, is primarily metabolized by cytochrome P450 3A4.
  • Fluvoxamine, an antidepressant, is a known inhibitor of cytochrome P450 3A4.

Purpose of the Study:

  • To evaluate the impact of steady-state fluvoxamine on the pharmacokinetics and pharmacodynamics of sildenafil.
  • To assess the safety and tolerability of co-administering fluvoxamine and sildenafil.

Main Methods:

  • A randomized, double-blind, placebo-controlled, crossover study involving 12 healthy male participants.
  • Participants received oral fluvoxamine or placebo for 10 days, followed by a single 50 mg dose of sildenafil on day 11.
  • Sildenafil plasma concentrations were measured using liquid chromatography/mass spectrometry, and its effect on sodium nitroprusside-induced venodilation was assessed.

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Main Results:

  • Fluvoxamine significantly increased sildenafil exposure (area under the curve) by 40% and its half-life by 19%.
  • Sodium nitroprusside-induced venodilation was augmented by 59% during fluvoxamine co-administration compared to placebo.
  • Sildenafil was well tolerated when taken with fluvoxamine.

Conclusions:

  • Fluvoxamine causes mild pharmacokinetic changes in sildenafil, leading to enhanced vascular effects.
  • While the interaction may not be clinically significant, a reduced starting dose of sildenafil (25 mg) is advisable for patients taking fluvoxamine concurrently.