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Related Experiment Videos

Pharmacokinetic interaction between ritonavir and clarithromycin

D Ouellet1, A Hsu, G R Granneman

  • 1Abbott Laboratories, Abbott Park, Ill, USA.

Clinical Pharmacology and Therapeutics
|November 3, 1998
PubMed
Summary

Ritonavir significantly increases clarithromycin levels, prolonging its half-life. However, no dose adjustments are needed for either drug in patients with normal renal function.

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Area of Science:

  • Pharmacology
  • Drug Interactions
  • Clinical Pharmacokinetics

Background:

  • Ritonavir (HIV protease inhibitor) and clarithromycin (antibiotic for Mycobacterium avium complex) are often co-administered.
  • Both drugs are metabolized by and inhibit cytochrome P450 enzymes, suggesting potential drug interactions.

Purpose of the Study:

  • To evaluate the pharmacokinetic effects of combining ritonavir and clarithromycin.
  • To assess potential drug interactions between these two medications.

Main Methods:

  • An open-label, randomized, 3-period crossover study involving 22 healthy volunteers.
  • Administration of ritonavir alone, clarithromycin alone, and the combination.
  • Pharmacokinetic analysis of drug concentrations and metabolite formation.

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Main Results:

  • Ritonavir significantly inhibited clarithromycin metabolism, increasing its AUC by 77% and half-life to 14 hours.
  • Clarithromycin significantly increased ritonavir AUC by 12.5% and peak concentration by 15.3%.
  • Formation of the clarithromycin metabolite 14-(R)-hydroxyclarithromycin was nearly completely inhibited by ritonavir.

Conclusions:

  • No ritonavir dose adjustment is required when co-administered with clarithromycin.
  • No clarithromycin dose adjustment is recommended for patients with normal renal function.
  • The pharmacokinetic interaction is manageable without dose modification in this population.