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Midazolam should be avoided in patients receiving the systemic antimycotics ketoconazole or itraconazole
Abstract
Interaction between ketoconazole, itraconazole, and midazolam was investigated in a double-blind, randomized crossover study of three phases at intervals of 4 weeks. Nine volunteers were given either 400 mg ketoconazole, 200 mg itraconazole, or matched placebo orally once daily for 4 days. On day 4, the subjects ingested 7.5 mg midazolam. Plasma samples were collected and psychomotor performance was measured. Both ketoconazole and itraconazole increased the area under the midazolam concentration-time curve from 10 to 15 times (p < 0.001) and mean peak concentrations three to four times (p < 0.001) compared with the placebo phase. In psychomotor tests (e.g., the Digit Symbol Substitution Test), the interaction was statistically significant (p < 0.05) until at least 6 hours after drug administration. Inhibition of the cytochrome P450IIIA by ketoconazole and itraconazole may explain the observed pharmacokinetic interaction. Prescription of midazolam for patients receiving ketoconazole and itraconazole should be avoided.
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Cited by
Dresser, G. K., Spence, J. D., & Bailey, D. G. (2000) · Clinical Pharmacokinetics · doi:10.2165/00003088-200038010-00003 · Cited by 908
Stevens, D. A., Moss, R. B., Kurup, V. P., Knutsen, A. P., Greenberger, P., Judson, M. A., Denning, D. W., Crameri, R., Brody, A. S., Light, M., et al. (2003) · Clinical Infectious Diseases · doi:10.1086/376525 · Cited by 790
Effects of the Antifungal Agents on Oxidative Drug Metabolism: Clinical Relevance
Venkatakrishnan, K., von Moltke, L. L., & Greenblatt, D. J. (2000) · Clinical Pharmacokinetics · doi:10.2165/00003088-200038020-00002 · Cited by 508
Groll, A. H., Piscitelli, S. C., & Walsh, T. J. (1998) · Advances in pharmacology · doi:10.1016/s1054-3589(08)60129-5 · Cited by 377
(1997) · PubMed · Cited by 271
Metadata
- Authors
- Olkkola, K. T., Backman, J. T., & Neuvonen, P. J.
- Venue
- Clinical Pharmacology and Therapeutics
- Publisher
- Wiley
- Published
- 1994-05
- Volume
- 55
- Issue
- 5
- Pages
- 481-485
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2054040800
- Cited by
- 409
- References
- 0
- FWCI
- 19.73
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Midazolam should be avoided in patients receiving the systemic antimycotics ketoconazole or itraconazole. https://app.cochat.ai/papers/10.1038/clpt.1994.60
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- Olkkola, K. T., Backman, J. T., & Neuvonen, P. J. (1994). Midazolam should be avoided in patients receiving the systemic antimycotics ketoconazole or itraconazole. Clinical Pharmacology and Therapeutics. https://doi.org/10.1038/clpt.1994.60
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