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Pregnancy: There are no adequate and well-controlled studies in pregnant women with FORDICA 500 XR. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day.
Nursing Mothers: Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If FORDICA 500 XR is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
