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Dose-dependent uricosuric effect of ambroxol

B Oosterhuis1, G Storm, P J Cornelissen

  • 1Pharma Bio-Research International B. V., Zuidlaren, The Netherlands.

European Journal of Clinical Pharmacology
|January 1, 1993
PubMed
Summary
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High doses of ambroxol significantly reduce plasma uric acid levels in a dose-dependent manner. This expectorant demonstrates a uricosuric effect, increasing uric acid clearance without impacting creatinine levels.

Area of Science:

  • Pharmacology
  • Nephrology
  • Internal Medicine

Background:

  • Ambroxol is recognized for its expectorant properties, promoting bronchial secretion.
  • Prior research indicated that elevated ambroxol doses might lower plasma uric acid concentrations.

Purpose of the Study:

  • To validate the uricosuric effect of ambroxol.
  • To establish the dose-response relationship for this effect.
  • To elucidate the mechanism of action behind ambroxol's impact on uric acid levels.

Main Methods:

  • A placebo-controlled, double-blind study involving 48 healthy males.
  • Random allocation to receive placebo or ambroxol (125 mg, 250 mg, or 500 mg) twice daily for five days.
  • Collection of blood and urine samples to measure uric acid, creatinine, xanthine, and ambroxol levels.

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Main Results:

  • Ambroxol demonstrated a significant, dose-dependent reduction in plasma uric acid at 250 mg and 500 mg doses (approximately 20% and 30% decrease, respectively).
  • Uric acid clearance increased dose-dependently, while creatinine clearance remained unaffected.
  • No significant changes in plasma hypoxanthine levels or adverse events were observed.

Conclusions:

  • Oral administration of higher ambroxol doses (250-500 mg twice daily) exhibits a uricosuric effect.
  • Ambroxol is well-tolerated at these therapeutic doses.
  • The study confirms ambroxol's potential role in managing conditions related to uric acid levels.