Glipizide and metformin Pregnancy Warnings
Glipizide has been shown to be mildly fetotoxic in rat reproductive studies at dose levels from 5 to 50 mg/kg. This fetotoxicity appears to be a perinatal effect and believed to be directly related to the hypoglycemic action of the drug. No teratogenicity was observed. Metformin was not teratogenic in rats or rabbits at doses up to 600 mg/kg. Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Sulfonylureas are generally not suitable for the treatment of diabetes during pregnancy as significant metabolic changes occur during this time make control of blood sugar difficult. Neonates born to mothers receiving sulfonylureas at the time of delivery have experienced prolonged severe hypoglycemia, especially with use of agents that have prolonged half-lives. There are no adequate and well-controlled studies in pregnant women.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: C
Comments:
-Insulin is recommended during pregnancy to maintain blood glucose levels as normal as possible.
-If this drug is used during pregnancy, it should be discontinued at least 1 month before the expected delivery date.
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Glipizide and metformin Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes (glipizide); Yes (metformin)
Comments: If diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
Both glipizide and metformin are found in low levels in human milk. Metformin drug levels are expected to be 0.5% of their mother's weight-adjusted dosage and are expected to be relatively constant. In 1 large study in mothers receiving metformin, no adverse effects were observed in their breastfed infants; there were low detectable serum levels in some infants. Limited data is available with use of glipizide.
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