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Alendronate / cholecalciferol Pregnancy and Breastfeeding Warnings

Alendronate / cholecalciferol is also known as: Fosamax Plus D

Alendronate / cholecalciferol Pregnancy Warnings

Alendronate-cholecalciferol has been assigned to pregnancy category C by the FDA. Animal studies in rats have revealed evidence of incomplete fetal ossification, protracted parturition, and maternal toxicity at alendronate doses 1 to 9 times the 10 mg human dose (based on mg/m2). No similar effects were noted in rabbits treated at doses 50 times the human 10 mg dose (based on mg/m2). There are no controlled data in human pregnancy. Alendronate-cholecalciferol is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Alendronate / cholecalciferol Breastfeeding Warnings

Though absorption of alendronate by a breastfed infant is unlikely, an alternate drug may be preferred since no information exists on its use during breastfeeding.

Cholecalciferol and some of its active metabolites pass into breast milk. There are no data on the excretion of alendronate into human milk. The manufacturer recommends that caution be used when administering alendronate-cholecalciferol breast-feeding women.

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