Abstract
Low misoprostol dose (μg range), extremely low plasma levels (pg range) of misoprostol acid, and the necessity of using a complex, time consuming, and labor intensive RIA method of analysis make it technically difficult to study the pharmacokinetic profile of misoprostol in man. The clinical relevance of the misoprostol pharmacokinetic data should be interpreted with care in view of the combined local and systemic effects of the drug. The studies presented in the present review indicate: • Extensive metabolism of misoprostal occurs during and/or prior to gastrointestinal absorption. • Several metabolites are formed and no unchanged drug is detected in the plasma or urine. • The biologically active metabolite in the plasma is misoprostal acid (SC-30695), a de-esterified derivative of misoprostal. • Absorption of misoprostal and/or misoprostal acid is extremely rapid resulting in peak plasma levels of misoprostol acid in less than 15 minutes. Absorption probably occurs in the stomach. • The elimination half-life of misoprostal acid is short (less than 30 minutes). • No accumulation of misoprostal acid occurs in plasma following a 400 μg q12h dosing regimen of misoprostal.
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