Treatment of bipolar disorder with lithium therapy during pregnancy is a medical challenge. Bipolar disorder is more prevalent in\r\nwomen and its onset is often concurrent with peak reproductive age. Treatment typically involves administration of the element\r\nlithium, which has been classified as a class D drug (legal to use during pregnancy, but may cause birth defects) and is one of only\r\nthirty known teratogenic drugs. There is no clear recommendation in the literature on the maximum acceptable dosage regimen for\r\npregnant, bipolar women.We recommend a maximum dosage regimen based on a physiologically based pharmacokinetic (PBPK)\r\nmodel. The model simulates the concentration of lithium in the organs and tissues of a pregnant woman and her fetus. First, we\r\nmodeled time-dependent lithium concentration profiles resulting from lithium therapy known to have caused birth defects. Next,\r\nwe identified maximum and average fetal lithium concentrations during treatment. Then, we developed a lithium therapy regimen\r\nto maximize the concentration of lithium in the mother�s brain, while maintaining the fetal concentration low enough to reduce\r\nthe risk of birth defects. This maximum dosage regimen suggested by the model was 400 mg lithium three times per day.
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