RiteMED Glibenclamide Use In Pregnancy & Lactation

Use 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.)
Achieving normoglycemia is significant to pregnant women. If the patient is pregnant, treatment with glibenclamide or other oral hypoglycemic agents should be replaced by insulin, with the supervision of a physician.
Glibenclamide may enter fetal circulation which may cause neonatal hypoglycemia. Embryotoxicity and birth defects were seen after giving glibenclamide to animals.
Use in lactating mothers: Sulfonylureas, in general, are known to be excreted in breast milk. However, one study showed that glibenclamide was not found in breast milk.
Five women were given a daily dosage of 5 mg of glibenclamide starting on the first post partum day. No drug was detected in the breast milk of the mothers and hypoglycemia was not observed in the nursing infants.
Therefore, it is best to use glibenclamide with caution in lactating mothers.