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Thursday, March 26, 2015

Breastfeeding recommendations for Daflon

Manufacturers recommendations:
  • In the absence of data concerning the diffusion into breast milk,breastfeeding is not recommended during treatment
Factors to Consider during Dosing: 
  • Expression into breastmilk (in rats):
    • passage into breast milk was assessed as 1% of the dose administered to the mother
  • Volume of distribution is 60L. 
    • the higher volume distribution means the lesser tendency to stay in the blood and will distribute to other body fluid
  • Half life: 26-43hours
    • Thus it takes about 1-2 days to achieve 50% of drug level in blood. 
    • Some recommendations is to wait about 7-10 days (6-7 half life) before starting to breastfeed.
  • Monitoring parameter
    • based on pregnancy information in rat/mice, no teratogenicity was seen. 
    • Thus no information of factors to monitor
References:
  1. daflon 500mg.  http://www.mims.com/Malaysia/drug/info/Daflon%20500%20mg/?type=full
  2. Safety and security of Daflon 500 mg in venous insufficiency and in hemorrhoidal disease. http://www.ncbi.nlm.nih.gov/pubmed/8203791
  3. Diosvein. http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0325-04-Tab-C-vol257.pdf
  4. Daflon 500. http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0358-02-Submission-for-Diosmin-vol280.pdf

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