PHARMACOKINETICS OF AMOXICILLIN DURING PREGNANCY AND POSTPARTUM

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pregnant women are considered an "orphan" population for drug development. Even for drugs commonly administered to pregnant women, such as amoxicillin, there is very limited information available on the pharmacokinetics (PK) of the drug during pregnancy as compared to postpartum. During the recent anthrax scare in Washington DC, there were many individuals exposed or potentially exposed to anthrax spores who received antibiotic prophylaxis. Some of these individuals were pregnant. Because of the lack of information on the PK of amoxicillin during pregnancy and the expected increased elimination of drugs (such as amoxicillin) eliminated by the kidneys during pregnancy, physicians can only guess at the appropriate dose to use. The purpose of this study is to evaluate the pharmacokinetics of amoxicillin during pregnancy and postpartum. We will give healthy pregnant women a single oral dose of amoxicillin (500 mg) during the second (18-22 weeks gestation) and third (30-34 weeks gestation) trimesters of pregnancy and 3 months postpartum. Blood and urine samples will be collected throughout the study days. Healthy pregnant women prior to 18 weeks gestation will be recruited for this study.