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Betaxolol ophthalmic Pregnancy and Breastfeeding Warnings

Betaxolol ophthalmic is also known as: Betoptic, Betoptic S

Betaxolol ophthalmic Pregnancy Warnings

Betaxolol ophthalmic 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. There are no controlled data in human pregnancy. Betaxolol ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

Data from two studies in which pregnant women treated for hypertension with oral 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 ophthalmic Breastfeeding Warnings

There are no data on the excretion of betaxolol ophthalmic into human milk. Betaxolol has been reported to be excreted into human milk after oral administration. Other systemic beta-blockers and topical timolol maleate are excreted in milk. In general, most experts recommend monitoring of nursing infants for signs and symptoms of beta-blockade, such as bradycardia and hypoglycemia. The manufacturer recommends caution when administering betaxolol ophthalmic 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 oral 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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