Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation
Pregnancy:
It is recommended that Neobloc should not be administered during pregnancy or lactation unless it is considered that the benefit outweighs the possible risk to the foetus/infant. Should therapy with metoprolol be employed, special attention should be paid to the foetus, neonate and breast fed infant for any undesirable effects such as slowing of the heart rate.

Metoprolol has, however, been used in pregnancy associated hypertension under close supervision after 20 weeks gestation. Although the drug crosses the placental barrier and is present in cord blood no evidence of foetal abnormalities have been reported. However, there is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. Beta blockers reduce placental perfusion and may cause foetal death and premature birth. Intrauterine growth retardation has been observed after long- time treatment of pregnant women with mild to moderate hypertension. Beta blockers have been reported to cause bradycardia in the foetus and the newborn child, there are also reports of hypoglycaemia and hypotension in newborn children.

Animal experiments have shown neither teratogenic potential nor other adverse events on the embryo and/or foetus relevant to the safety assessment of the product.

Treatment with metoprolol should be discontinued 48-72 hours before the calculated birth date. If this is not possible, the newborn child should be monitored for 24-48 hours postpartum for signs and symptoms of beta blockade (e.g. cardiac and pulmonary complications).

Breast-feeding:The concentration of metoprolol in breast milk is approximately three times higher than the one in the mother's plasma. The risk of adverse effects in the breastfeeding baby would appear to be low after administration of therapeutic doses of the medicinal product (except in individuals with poor metabolic capacity). Cases of neonatal hypoglycaemia and bradycardia have been described with beta-blockers with low plasma protein binding. Metoprolol is excreted in human milk. Even though the metoprolol concentration in milk is very low, breast-feeding should be discontinued during treatment with metoprolol. In case of treatment during breast-feeding, infants should be monitored carefully for symptoms of beta blockade.