Asenza Plus Use In Pregnancy & Lactation

Pregnancy: Limited data with Pioglitazone/Glimepiride Tablets or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are clinical considerations related to fetal and neonatal adverse reactions and drug discontinuation if glimepiride is used during pregnancy. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, Pioglitazone/Glimepiride Tablets should be discontinued at least two weeks before expected delivery.
Lactation: There is no information regarding the presence of pioglitazone or glimepiride in human milk, the effects on the breastfed infant, or the effects on milk production. Pioglitazone and glimepiride are present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Pioglitazone/Glimepiride Tablets and any potential adverse effects on the breastfed infant from Pioglitazone/Glimepiride Tablets or from the underlying maternal condition.