Chemical formula: C₁₉H₂₄N₂O₃ Molecular mass: 328.406 g/mol PubChem compound: 3869
On the basis of experience during human pregnancy, it is unexpected that labetalol increases the risk of birth defects. Animal studies have not demonstrated reproductive toxicity. However, toxicity has been demonstrated in embryo-foetal development. Labetalol crosses the placenta barrier and because of the pharmacological activity of alpha- and beta- adreneceptor blockade, side effects in the foetus and neonate should be borne in mind (bradycardia, hypotension, respiratory depression, hypoglycemia, hypothermia). Close observation up to 24 to 48 hours after birth is required.
Response to supportive measures (e.g. intravenous fluids and glucose) is usually prompt but with severe preeclampsia, particularly after prolonged intravenous labetalol, recovery may be slower. This may be related to diminished liver metabolism in premature babies.
Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. Intra-uterine and neonatal deaths have been reported with labetalol but other drugs (e.g. vasodilators, respiratory depressants) and the effects of preeclampsia, intra-uterine growth retardation and prematurity were implicated.
Such clinical experience warns against unduly prolonging high dose labetalol and delaying delivery and against co-administration of hydralazine.
Labetalol should only be used during the pregnancy if the potential benefit for the mother outweighs the potential risk for the foetus.
Labetalol is excreted in breast milk in small amounts (approximately 0.004-0.07% of the dose administered to the mother). Breast-feeding is therefore not recommended. No side-effects have been reported. Monitoring is needed if labetalol is used in lactating mothers.
There is no information available on the effect labetalol has on the fertility.
There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.
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