Glipizide Pregnancy and Breastfeeding Warnings

Glipizide is also known as: GlipiZIDE XL, Glucotrol, Glucotrol XL

Glipizide Pregnancy Warnings

-Glipizide was found to be mildly fetotoxic in rat reproductive studies. No teratogenic effects were found in rat or rabbit studies. -Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. -There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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.

UK: Use is contraindicated. US: Benefit should outweigh risk. AU: The manufacturer makes no recommendation regarding use during pregnancy. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Use of insulin is recommended during pregnancy to maintain blood glucose levels as normal as possible. -Sulfonylureas are not suitable for the treatment of diabetes mellitus during pregnancy as significant metabolic changes occur during this period, which make control difficult.

Glipizide Breastfeeding Warnings

UK: Use is contraindicated. AU, US: 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: Unknown Excreted into animal milk: Data not available Comments: If the drug is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Although it is unknown whether this drug is excreted in human milk, some sulfonylureas are known to be excreted in human milk; therefore the potential for hypoglycemia in nursing infants may exist.

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