An Observational Study on the Pharmacokinetics of Oseltamivir in Lactating Influenza Patients

Clin Pharmacol Ther. 2023 Nov 17. doi: 10.1002/cpt.3107. Online ahead of print.ABSTRACTInfluenza infection may lead to serious complications in the postpartum period, therefore, oseltamivir treatment in these patients and their breastfed infants is of great importance. However, the pharmacokinetics of oseltamivir in postpartum lactating women with acute influenza infection, and the consequent infant exposure to oseltamivir are still unknown, and these data would help in assessing risk and the need for dose adjustment in breastfed infants. Six lactating women with influenza-like symptoms, at a standard dose of 75 mg oral oseltamivir twice daily for 5 days, were recruited in this phase 4 clinical study during the 2011/2012 H1N1 pandemic seasons. Breast milk/colostrum and venous blood samples were taken at multiple time points, maternal urine samples were obtained from total output within the 12-hour observational period following the 7th dose of oseltamivir. Oseltamivir phosphate (OP) reached a maximum 69.5±29.4 ng/mL concentration in breast milk, higher than that found in the plasma, and showed elimination within approximately 8 hours. Oseltamivir carboxylate (active metabolite of OP) showed a lower, nearly steady state concentration in breast milk during the observational period (Cmax =38.4±12.9 ng/mL). Based on estimated daily milk consumption of exclusively breastfed infants, their calculated daily exposure is less than 0.1% of the infant dose of oseltamivir for treatment...
Source: Clinical Pharmacology and Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research