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Pharmacokinetics of roxithromycin (RU 965)
1Section of Clinical Pharmacology, Hoechst-Roussel Pharmaceuticals Inc., Somerville, New Jersey 08876.
Journal of Clinical Pharmacology
|February 1, 1988
Summary
This study evaluated roxithromycin (RU 965), a macrolide antibiotic, finding it rapidly absorbed with a 12-hour half-life. Roxithromycin is safe and well-tolerated, with minimal impact from age or milk consumption.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Metabolism
Background:
- Roxithromycin (RU 965) is a novel macrolide antibiotic.
- Understanding its pharmacokinetic profile is crucial for effective therapeutic use.
Purpose of the Study:
- To evaluate the pharmacokinetics of roxithromycin following oral administration.
- To assess the influence of dose, age, and food on roxithromycin's absorption, distribution, metabolism, and excretion.
Main Methods:
- Five studies were conducted involving oral administration of 150-mg and 300-mg film-coated roxithromycin tablets.
- Plasma levels, half-life, urinary excretion, and bioavailability were measured.
- Pharmacokinetic parameters were analyzed in relation to dose, age, and co-administration with milk.
Main Results:
- Roxithromycin is rapidly absorbed, reaching peak plasma levels within two hours.
- Steady-state plasma concentrations are achieved within four days.
- The elimination half-life is approximately 12 hours, with about 10% of the dose excreted in urine.
- Absorption rates are unaffected by age, though elimination and renal clearance decrease in the elderly, without clinical significance.
- Bioavailability is not significantly impacted by milk intake.
Conclusions:
- Roxithromycin exhibits predictable pharmacokinetics with rapid absorption and a favorable half-life.
- The drug is safe and well-tolerated across the studied doses and conditions.
- Age and milk consumption do not significantly alter roxithromycin's clinical efficacy or safety profile.