Abstract
Objective: The study-aim was to determine if administration of the prodrugs bisacodyl (Bisa) and sodium picosulfate (SPS) leads to excretion of their common active metabolite, BHPM in breast milk.
Methods: Two groups of 8 healthy lactating women who stopped breast feeding, received multiple doses of Bisa or SPS. Plasma, urine, and breast milk were collected and concentrations of free and total BHPM were determined using validated LCMS methods.
Results: BHPM remained below limits of detection in breast milk following single and multiple-dose administration of Bisa and SPS. First BHPM plasma concentrations were observed after a lag-time of about 3 to 4 hr and 4 to 5 hr following Bisa and SPS administration, respectively. Cmax was attained approximately 5 hr after dosing of Bisa and 9 hr after dosing of SPS. BHPM did not accumulate after multiple administrations of Bisa and only slightly accumulated following multiple doses of SPS. About 12% and 13% of Bisa and SPS was excreted as BHPM into urine at steady state.
Conclusion: BHPM, the active moiety of Bisa and SPS was not excreted into human breast milk. Hence, use of Bisa or SPS to treat constipation of breast feeding women is considered well tolerated with regard to exposing infants to BHPM via breast milk.
