<p><strong>Pregnancy</strong>: Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of Pentosan Polysulfate Sodium when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from Pentosan Polysulfate Sodium. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.<br />
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<strong>Nursing Mothers</strong>: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pentosan Polysulfate Sodium is administered to a nursing woman.</p>