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Penbutolol Pregnancy and Breastfeeding Warnings

Penbutolol is also known as: Levatol

Penbutolol Pregnancy Warnings

There are no reports of the use of penbutolol during pregnancy. As with other beta-blockers, it is recommended that newborns of mothers who were exposed to penbutolol near term or delivery be monitored for signs or symptoms of beta-blockade (bradycardia, hypotension, hypoglycemia) for at least 48 hours.

Penbutolol has been assigned to pregnancy category C by the FDA. Animal studies have revealed fetotoxicity only after extraordinary doses. No teratogenic effects were observed after rats and rabbits were given doses equivalent to 250 times the maximum recommended human dose, but a slight increase in intrauterine and 24-hour postpartum fetal death and decreased pup body weight and survival were observed after rats were given doses equivalent to 155 times the maximum recommended human dose. Fetotoxicity was not observed when lesser doses were given. There are no controlled data in human pregnancy. Penbutolol should only be given during pregnancy when benefit outweighs risk.

Penbutolol Breastfeeding Warnings

There are no data on the excretion of penbutolol into human milk. As with other beta-blockers, it is recommended that nursing infants whose mothers were exposed to penbutolol near term or delivery or who are taking penbutolol be monitored for signs or symptoms of beta-blockade (bradycardia, hypotension, hypoglycemia).

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