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Related Experiment Videos

Etintidine-theophylline interaction study in humans.

S M Huang1, H S Weintraub, T B Marriott

  • 1Research Laboratories, Ortho Pharmaceutical Corporation, Raritan, NJ 08869.

Biopharmaceutics & Drug Disposition
|November 1, 1987
PubMed
Summary
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Etintidine HCl, a histamine H2-blocker, significantly reduced theophylline clearance and prolonged its half-life in healthy volunteers. This drug interaction may affect theophylline dosing in patients using etintidine.

Area of Science:

  • Pharmacology
  • Drug Metabolism
  • Clinical Pharmacology

Background:

  • Histamine H2-receptor antagonists are widely used for acid suppression.
  • Theophylline, a bronchodilator, has a narrow therapeutic index and is subject to drug interactions.
  • Etintidine HCl is a potent H2-blocker whose potential interactions require investigation.

Purpose of the Study:

  • To investigate the effect of clinical doses of etintidine HCl on the pharmacokinetic disposition of theophylline in healthy male volunteers.
  • To compare theophylline pharmacokinetics when co-administered with etintidine versus placebo.

Main Methods:

  • A double-blind, two-way crossover study involving 10 male volunteers.
  • Subjects received etintidine HCl (400 mg) or placebo twice daily for 4 days.

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  • An oral theophylline dose was administered on Day 4, with plasma levels monitored for 24 hours.
  • Plasma theophylline concentrations were analyzed using High-Performance Liquid Chromatography (HPLC).

    • Main Results:

    • Theophylline absorption (Cmax, Tmax) was not significantly affected by etintidine.
    • Etintidine HCl significantly reduced the oral clearance of theophylline (p = 0.000006).
    • Etintidine HCl significantly prolonged the elimination half-life of theophylline (16.8 hours vs 6.0 hours).

    Conclusions:

    • Etintidine HCl significantly alters the disposition of theophylline in humans.
    • Etintidine HCl prolongs the elimination of theophylline, similar to cimetidine.
    • This interaction necessitates careful consideration of theophylline dosage in patients concurrently treated with etintidine HCl.