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Betaxolol Pregnancy and Breastfeeding Warnings

Betaxolol is also known as: Kerlone

Betaxolol Pregnancy Warnings

Data from two studies in which pregnant women treated for hypertension with betaxolol are available. In two studies of 28 and 22 pregnant women treated for hypertension with betaxolol 10 to 40 mg per day, the mean umbilical cord to maternal plasma betaxolol concentration ratio was 0.93 and 0.91, respectively, within a few hours after dosing. This ratio indicates nearly free transfer of betaxolol across the placenta. The 22 women from one study gave birth to 23 live infants with mean Apgar scores of 8.3 and 9.1 at one and five minutes, respectively. Fetal heart rates were significantly decreased in five infants (four during birth), but the acceleration-deceleration range was not affected. All three instances of fetal distress were explicable by obstetrical causes, and were not thought to be due to betaxolol. At 9 months, all infants were normal and healthy.

Betaxolol has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity, but increased postimplantation loss, reduced litter size and weight, and an increased incidence of skeletal and visceral abnormalities as well as incomplete testicular descent were noted in rats given 6 to 600 times the maximum recommended human dose (on a per kg basis). There are no controlled data during human pregnancy. Betaxolol should only be given during pregnancy when benefit outweighs risk.

Betaxolol Breastfeeding Warnings

Betaxolol is excreted into human milk in sufficient amounts to have pharmacologic effects in the infant. For this reason, the manufacturer recommends caution be used when administering betaxolol to nursing women.

Milk betaxolol concentrations were measured and compared to maternal plasma concentrations in three women. Milk concentrations ranged from 4.2 to 48 ng/mL 27 to 97 hours after the last dose of betaxolol. The milk to maternal plasma concentration ratio ranged from 2.0 to 3.5 at 27 to 51 hours post-dose. In one case, the milk to plasma ratio was as high as 11.6 at 97 hours post-dose. Some experts recommend that breast-feeding during beta-blocker therapy should be undertaken only when the infant is closely monitored for adverse effects, such as bradycardia, hypotension, respiratory distress, or hypoglycemia.

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