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Ardeparin Pregnancy and Breastfeeding Warnings

Ardeparin is also known as: Normiflo

Ardeparin Pregnancy Warnings

Animal studies using subcutaneous doses 3 times (rats) to 10 times (rabbits) the recommended human dosage did not result in impaired fertility or fetal harm. However, doses of ardeparin 7 times (rats) to 11 times (rabbits) the recommended human dosage resulted in scoliosis, interventricular septal defects, stenosis of the aortic arch and pulmonary trunk, and fused sternebrae.

Ardeparin has been assigned to pregnancy category C by the FDA. Animals studies using subcutaneous dosing did not result in impaired fertility or fetal harm. However, intravenously administered doses in pregnant animals revealed evidence of teratogenic effects. There are no controlled data in human pregnancy. Ardeparin should only be used during pregnancy when the benefit outweighs the risk.

Ardeparin Breastfeeding Warnings

There are no data on the excretion of ardeparin into human milk. The manufacturer recommends that caution be used when administering ardeparin to nursing women.

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