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DRUG INTERACTIONS

Influence of Goldenseal Root on the Pharmacokinetics of Indinavir

Ranjeev S. Sandhu, PharmD, Randy P. Prescilla, MD, Thomas M. Simonelli, PharmD and David J. Edwards, PharmD

From the Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan (Dr. Sandhu, Dr. Simonelli, Dr. Edwards); Division of Clinical Pharmacology, Department of Pediatrics, School of Medicine, Wayne State University, Detroit, Michigan (Dr. Prescilla, Dr. Edwards); and Division of Endocrinology, Department of Pediatrics, School of Medicine, Wayne State University, Detroit, Michigan (Dr. Prescilla).

Goldenseal root was identified as the most potent inhibitor of CYP3A4 in a study that tested 21 popular herbal products for in vitro inhibitory activity. The purpose of this investigation was to examine the influence of goldenseal root on the disposition of the CYP3A4 substrate indinavir in humans. Using a crossover study design, the pharmacokinetics of indinavir were characterized in 10 healthy volunteers before and after 14 days of treatment with goldenseal root (1140 mg twice daily). Indinavir was given as a single 800-mg oral dose, and blood samples were collected for 8 hours following the dose. No statistically significant differences in peak concentration (11.6 vs. 11.9 mg/L) or oral clearance (26.8 vs. 23.9 mg•h/L) were observed following treatment with goldenseal root. Half-life and time to reach peak concentration were also unchanged by goldenseal. These results suggest that patients being treated with indinavir can safely take goldenseal root and that interactions with other drugs metabolized by CYP3A4 in the liver are unlikely.

Key Words: Goldenseal root • indinavir • herbal medicine • drug interactions

Address for reprints: David J. Edwards, PharmD, Professor, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy & Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI 48201.




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Comment: Community Identification of Natural Health Product Drug Interactions
Ann. Pharmacother., December 1, 2007; 41(12): 2073 - 2073.
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