Carivalan Use In Pregnancy & Lactation

Women of child-bearing potential: Women of child-bearing potential should use appropriate contraceptive measures during treatment.
Pregnancy: Based on existing data with the individual components, the use of Carvedilol + Ivabradine (Carivalan) is contra-indicated during pregnancy.
There are insufficient data on the use of carvedilol in pregnant women. Experimental animal studies have shown reproductive toxicity. The potential risk use in humans is unknown. Beta-blockers reduce placental perfusion which may result in intrauterine fetal death and immature and premature deliveries. In addition, adverse effects (especially hypoglycemia and bradycardia, hypotension, respiratory depression and hypothermia) may occur in the fetus and neonate. There may be an increased risk of cardiac and pulmonary complications in the neonate during the postnatal period. There are no or limited amount of data from the use of ivabradine in pregnant women.
Animal studies with ivabradine have shown reproductive toxicity. These studies have shown embryotoxic and teratogenic effects. The potential risk for humans is unknown.
Breast-feeding: Carvedilol + Ivabradine (Carivalan) is contra-indicated during breast-feeding.
Animal studies have shown that carvedilol or its metabolites are excreted in the breast milk.
It is not known whether carvedilol is excreted in the human breast milk. Animal studies indicate that ivabradine is excreted in milk. Women that need treatment with ivabradine should stop breast-feeding and choose for another way of feeding their child.