Pentosan polysulfate sodium Pregnancy and Breastfeeding Warnings
Pentosan polysulfate sodium is also known as: Elmiron
Pentosan polysulfate sodium Pregnancy Warnings
Pentosan polysulfate sodium was studied in eight cases of medical abortion. A single 50 mg dose of pentosan polysulfate sodium was administered intravenously during mid trimester of pregnancy. Blood samples were obtained at 30 minutes from the mother and the fetus and hematologic values were compared with normal controls obtained under the same conditions. The mothers displayed a prolonged APTT, decreased factor Xa production and decreased factor V levels. Conversely, the fetuses displayed no hematologic laboratory abnormalities.
Pentosan polysulfate sodium has been assigned to pregnancy category B by the FDA. Animal studies have not revealed evidence of fetotoxicity. There are no controlled data in human pregnancy. Pentosan polysulfate sodium is only recommended for use during pregnancy when benefit outweighs risk.
Pentosan polysulfate sodium Breastfeeding Warnings
There are no data on the excretion of pentosan polysulfate sodium into breast milk. The manufacturer recommends that caution be used when administering pentosan polysulfate sodium to nursing women.
References for pregnancy information
- Forestier F, Fischer AM, Daffos F, Beguin S, Diner H "Absence of transplacental passage of pentosan polysulfate during mid trimester of pregnancy." Thromb Haemost 56 (1986): 247-9
References for breastfeeding information
- "Product Information. Elmiron (pentosan polysulfate sodium)." Baker Norton Pharmaceuticals, Miami, FL.
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