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Related Experiment Videos

[Toxicologic study on the antihypertensive agent urapidil].

J König, E D Meier-Dörzenbach, H G Menge

    Arzneimittel-Forschung
    |January 1, 1977
    PubMed
    Summary
    This summary is machine-generated.

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    Urapidil (Ebrantil) demonstrated sedation in rodents at high doses, with no adverse effects observed in rats at doses 42 times the human therapeutic level. Reproductive studies confirmed urapidil is not teratogenic.

    Area of Science:

    • Pharmacology
    • Toxicology
    • Preclinical Research

    Context:

    • Urapidil, an antihypertensive agent, requires comprehensive safety evaluation.
    • Understanding the toxicological profile of urapidil is crucial for its clinical application.

    Purpose:

    • To assess the acute and chronic toxicity of urapidil in animal models.
    • To investigate the reproductive and developmental effects of urapidil.

    Summary:

    • Acute toxicity studies in rats and mice revealed sedation, tremor, and convulsions at lethal doses of urapidil.
    • Subchronic and chronic oral administration studies in rats and dogs indicated that decreased body weight gain and sedation were key toxicity indicators.
    • The no-effect dose in rats was 42 times the human therapeutic dose, and in dogs, it ranged from 8 to 21 times the average therapeutic dose.

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  • Reproductive studies in mice, rats, and rabbits showed no teratogenic effects, and the development and reproductive capacity of the F1 generation remained unaffected, although species-specific estrus cycle inhibition was noted in rats.

    • Impact:

    • This study provides a comprehensive toxicological and reproductive safety profile for urapidil.
    • Findings support the established therapeutic use of urapidil by demonstrating a wide safety margin in preclinical models.
    • The data is essential for regulatory submissions and clinical risk-benefit assessments of urapidil.