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Safety and pharmacokinetics: colloidal bismuth subcitrate
1Dept. of Pharmacy, University of California, San Francisco 94143-0446.
Scandinavian Journal of Gastroenterology. Supplement
|January 1, 1991
Summary
Oral bismuth subcitrate shows low bioavailability (0.16–0.28%) and clearance (50–95 ml/min). Bismuth toxicity is unlikely at steady-state concentrations of 50–100 ng/ml, even with transient peaks.
Area of Science:
- Pharmacokinetics
- Toxicology
- Drug Metabolism
Background:
- Colloidal bismuth subcitrate is used orally.
- Bismuth pharmacokinetics and toxicity require further elucidation.
Purpose of the Study:
- To analyze bismuth's pharmacokinetic profile after oral administration.
- To evaluate proposed safety and alarm levels for bismuth toxicity.
Main Methods:
- Analysis of blood and urine excretion data.
- Application of a three-compartment pharmacokinetic model.
- Review of existing literature on bismuth toxicity.
Main Results:
- Bismuth bioavailability ranges from 0.16–0.28%, with clearance between 50–95 ml/min.
- An intermediate half-life of 5–11 days dominates clearance and elimination.
- Proposed safety levels for bismuth toxicity (50 ng/ml) and alarm levels (100 ng/ml) may be overly cautious.
Conclusions:
- Bismuth neurotoxicity is unlikely at steady-state concentrations of 50–100 ng/ml.
- Transient high peak concentrations after oral dosing do not appear to be related to toxicity.
- Pharmacokinetic principles suggest minimal impact of peak concentrations on steady-state levels.