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Influence of Omeprazole on Bioavailability of Bismuth following Administration of a Triple Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline

From Axcan Pharma, Inc., Mont-Saint-Hilaire, Canada (Dr. Spénard); Department of Pharmacology, Faculty of Medicine, Université de Montréal, Canada (Dr. Spénard); and Algorithme Pharma, Inc., Montréal, Canada (Dr. Aumais, Ms. Massicotte, Mr. Tremblay, Dr. Lefebvre).

The objective of this study was to determine the impact of omeprazole on bismuth (Bi) bioavailability when given in a three-in-one capsule containing bismuth biskalcitrate, metronidazole, and tetracycline. Thirty-four healthy volunteers were randomly assigned to receive three capsules (each containing bismuth biskalcitrate 140 mg + metronidazole 125 mg + tetracycline 125 mg) qid alone x 6 days or the same treatment + omeprazole (OM) 20 mg bid. Blood was drawn at intervals for 24 hours after the last dose. After the last dose, mean (CV) C_min for plasma bismuth was 2882 pg/mL (36%) and 1195 pg/mL (23%) (p< 0.001), with and without OM, respectively. Mean (CV) C_max was 25,493 pg/mL (69%) and 8061 pg/mL (28%) (p < 0.001) with and without OM, respectively. AUC_0-24 increased by 2.9 in presence of OM (p < 0.001). Adverse events in both groups were usually mild and of a gastrointestinal nature, and all had resolved by the end of the trial. This study confirms an interaction between Bi biskalcitrate and OM. Risk of Bi toxicity, seen after long-term use of Bi compounds, is minimal here because plasma levels of Bi remained well below the toxic levels of 50 µg/L, and the treatment period with this triple capsule + OM is only 10 days, a substantially lower number of days compared to that which might produce Bi toxicity.

Key Words: Omeprazole • bismuth biskalcitrate • bioavailability • drug combinations

Address for reprints: Dr. Jean Spénard, Axcan Pharma, Inc., 597 boul Laurier, Mont-Saint-Hilaire Qc, Canada J3H 6C4.

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