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Esmolol Pregnancy and Breastfeeding Warnings

Esmolol is also known as: Brevibloc

Esmolol Pregnancy Warnings

Two cases regarding the use of esmolol during human pregnancy have been reported. In each case fetal bradycardia became a problem after esmolol administration. In the first case, esmolol 500 mcg/kg boluses, then an esmolol infusion at 50 mcg/kg/minute were given to a 29-year-old woman at 38 weeks' gestation to control supraventricular tachycardia secondary to thyrotoxicosis. The fetal heart rate decreased from 150 to 175 beats per minute to 70 to 80 beats per minute within 20 minutes after esmolol was started. An emergency cesarean section was successfully performed. The neonatal heart rate rose from 60 to 140 beats per minute after oxygen was administered. The infant recovered completely; no structural defects were observed. In another case, esmolol intravenous boluses, then 200 mcg/kg/min were administered to a 31-year-old woman at gestation week 22 to control blood pressure before surgical correction of a subarachnoid hemorrhage. The fetal heart rate decreased from 139 to 144 beats per minute to 131 to 137 beats per minute. No other adverse effects on the fetus were observed. After a successful recovery, the patient delivered a healthy 2,880 gram infant at 37 weeks' gestation. No abnormalities in the neonate were observed. Data from sheep have revealed a mean fetal to maternal serum esmolol concentration ratio of only 0.08, indicating that the fetus is exposed to only an extremely small amount of drug. The hemodynamic consequences of esmolol, however, may be detrimental to uterine blood flow. This may result in fetal hypoxemia.

Esmolol has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity or embryotoxicity, although increased fetal resorptions were observed in rabbits after 2,500 mcg per kg per min (5 times the maximum recommended human dose on a per kg basis) was administered for 30 minutes daily. There are no controlled data in human pregnancy. Esmolol should only be given during pregnancy when benefit outweighs risk.

Esmolol Breastfeeding Warnings

There are no data on the excretion of esmolol into human milk. The manufacturer recommends caution be used when administering esmolol to nursing women.

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