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Propranolol steady-state pharmacokinetics are unaltered by omeprazole
1Discipline of Clinical Pharmacology, Faculty of Medicine, Royal Newcastle Hospital, Australia.
European Journal of Clinical Pharmacology
|January 1, 1987
Summary
Omeprazole does not significantly alter the pharmacokinetics or clinical effects of propranolol when co-administered. This study found no significant changes in propranolol levels or its therapeutic action in normal subjects.
Area of Science:
- Pharmacology
- Clinical Pharmacy
Background:
- Propranolol is a beta-blocker used for various cardiovascular conditions.
- Omeprazole is a proton pump inhibitor commonly prescribed for acid-related gastrointestinal disorders.
- Potential drug interactions between propranolol and omeprazole require investigation due to their widespread use.
Purpose of the Study:
- To evaluate the effect of omeprazole on the pharmacokinetics of propranolol.
- To assess the impact of omeprazole on the clinical efficacy of propranolol.
Main Methods:
- A randomized, double-blind, cross-over study was conducted.
- Eight healthy subjects received propranolol (80 mg twice daily) with either omeprazole (20 mg daily) or placebo for two 8-day periods.
- Propranolol kinetics and clinical effects (via exercise tests) were measured on day 8 of each treatment period.
Main Results:
- Omeprazole did not significantly increase the area under the propranolol concentration/time curve (787.6 vs 802.5 ng·ml⁻¹·h).
- Maximum and minimum steady-state propranolol concentrations remained unaffected by concomitant omeprazole.
- Clinical effects of propranolol, assessed by exercise tests, were not enhanced by omeprazole.
Conclusions:
- Omeprazole, at typical therapeutic doses for peptic ulcer disease, does not significantly alter propranolol pharmacokinetics.
- Co-administration of omeprazole is unlikely to affect the clinical action of propranolol.
- This suggests a low risk of pharmacokinetic or pharmacodynamic interaction between these two medications.