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Glipizide Pregnancy and Breastfeeding Warnings

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

Glipizide Pregnancy Warnings

In rat reproductive studies, mild fetotoxic effects were observed at dose levels from 5 to 50 mg/kg. This is a perinatal effect and believed to be directly related to the hypoglycemic action of the drug. No teratogenic effects were found in rats and rabbits. Neonates born to mothers receiving a sulfonylurea at the time of delivery have experienced prolonged severe hypoglycemia, especially with use of agents that have prolonged half-lives. Recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Sulfonylureas may not be suitable for the treatment of diabetes during pregnancy as significant metabolic changes occurring during this time make control of blood sugar difficult. 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.

AU and UK: Use is contraindicated
US: Use during pregnancy only if the benefit justifies the risk to the fetus.

AU TGA pregnancy category: C
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.

See references

Glipizide 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

Comments: If diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

There is limited data which suggests low levels of this drug are present in breast milk. Due to the limited data available and the potential for hypoglycemia in the nursing infant, the manufacturer suggests women who are not able to manage their blood sugar on diet alone consider insulin therapy while breastfeeding.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Glucotrol (glipizide)." Pfizer US Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Glucotrol (glipizide)." Pfizer US Pharmaceuticals, New York, NY.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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