PENBUTOLOL
Drugs in Pregnancy and Lactation.
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Name: PENBUTOLOL
Class: Sympatholytic (Antihypertensive)
Risk Factor: CM*
Fetal Risk Summary
Penbutolol is a nonselective b1, b2-adrenergic blocking agent used in the treatment of hypertension. No teratogenic effects were noted in mice, rats, and rabbits treated with doses up to 250 times the maximum recommended human dose (MRHD) (1,2). A slight increase in fetal and newborn mortality was observed in rabbits given 156 times the MRHD (2). In rats dosed at 200 times the MRHD, decreased pup body weight and survival were observed (2). In mice, the drug produced no behavioral changes in the exposed offspring (1).
No reports describing the use of penbutolol in human pregnancy have been located. If used near delivery, the newborn infant should be closely observed for 24–48 hours for signs and symptoms of b-blockade. Long-term effects of in utero exposure to b-blockers have not been studied but warrant evaluation.
Some b-blockers may cause intrauterine growth retardation and reduced placental weight (e.g., see Atenolol and Propranolol). Treatment beginning early in the 2nd trimester results in the greatest weight reductions. This toxicity has not been consistently demonstrated in other agents within this class, but the relatively few pharmacologic differences among the drugs suggests that the reduction in fetal and placental weights probably occurs with all at some point. The lack of toxicity documentation may reflect the number and type of patients studied, the duration of therapy, or the dosage used, rather then a true difference among b-blockers. Although growth retardation is a serious concern, the benefits of maternal therapy with b-blockers may, in some cases, outweigh the risks to the fetus and must be judged on a case-by-case basis.
[*Risk Factor D if used in 2nd or 3rd trimesters.]
Breast Feeding Summary
No reports describing the use of penbutolol during human lactation or measuring the amount, if any, of the drug in breast milk have been located. If penbutolol is used during nursing, the infant should be closely monitored for hypotension, bradycardia, and other signs or symptoms of b-blockade. Long-term effects of exposure to b-blockers from milk have not been studied but warrant evaluation.
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References
- Sugisaki T, Takagi S, Seshimo M, Hayashi S, Miyamoto M. Reproductive studies of penbutolol sulfate given orally to mice. Oyo Yakuri 1981;22:289–305. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD: Johns Hopkins University Press, 1989:487.
- Product information. Levatol. Schwarz Pharma, 1997.
