The Basics

What is Acebutolol?

Used to treat high blood pressure and to treat an irregular heartbeat.

Brand names for Acebutolol

Sectral

How Acebutolol is classified

Antihypertensive Agents, Adrenergic Beta-Antagonists, Antiarrhythmics

Acebutolol During Pregnancy

Acebutolol pregnancy category

Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Acebutolol while pregnant

Reproduction studies have been performed with Sectral in rats (up to 630 mg/kg/day) and rabbits (up to 135 mg/kg/day). These doses are equivalent to approximately 31.5 and 6.8 times the maximum recommended therapeutic dose in a 60-kg human, respectively. The compound was not teratogenic in either species. In the rabbit, however, doses of 135 mg/kg/day caused slight fetal growth retardation; this effect was considered to be a result of maternal toxicity, as evidenced by reduced food intake, a lowered rate of body weight gain, and mortality. Studies have also been performed in these species with diacetolol (at doses of up to 450 mg/kg/day in rabbits and up to 1800 mg/kg/day in rats). Other than a significant elevation in postimplantation loss with 450 mg/kg/day diacetolol, a level at which food consumption and body weight gain were reduced in rabbit dams and a nonstatistically significant increase in incidence of bilateral cataract in rat fetuses from dams treated with 1800 mg/kg/day diacetolol, there was no evidence of harm to the fetus. There are no adequate and well-controlled trials in pregnant women. Because animal teratology studies are not always predictive of the human response, Sectral should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nonteratogenic Effects Studies in humans have shown that both acebutolol and diacetolol cross the placenta. Neonates of mothers who have received acebutolol during pregnancy have reduced birth weight, decreased blood pressure, and decreased heart rate. In the newborn the elimination half-life of acebutolol was 6 to 14 hours, while the half-life of diacetolol was 24 to 30 hours for the first 24 hours after birth, followed by a half-life of 12 to 16 hours. Adequate facilities for monitoring these infants at birth should be available.

Taking Acebutolol While Breastfeeding

What are recommendations for lactation if you're taking Acebutolol?

Because of the relatively extensive excretion of acebutolol and its active metabolite diacetolol into breastmilk and their extensive renal excretion, other agents may be preferred, especially while nursing a newborn or preterm infant.[1][2][3]

Maternal / infant drug levels

Because of the relatively extensive excretion of acebutolol and its active metabolite diacetolol into breastmilk and their extensive renal excretion, other agents may be preferred, especially while nursing a newborn or preterm infant.[1][2][3]

Possible effects of Acebutolol on milk supply

Relevant published information on the effects of beta-blockade or acebutolol during normal lactation was not found as of the revision date. A study in 6 patients with hyperprolactinemia and galactorrhea found no changes in serum prolactin levels following beta-adrenergic blockade with propranolol.[9]

Possible alternatives to Acebutolol

Propranolol, Labetalol, Metoprolol.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Boutroy MJ, Bianchetti G, Dubruc C et al. To nurse when receiving acebutolol: is it dangerous for the neonate? Eur J Clin Pharmacol. 1986;30:737-9. PMID: 3770068
2. Chow T, Galvin J, McGovern B. Antiarrhythmic drug therapy in pregnancy and lactation. Am J Cardiol. 1998;82:58I-62I. PMID: 9737655
3. Hale TW. Medications in breastfeeding mothers of preterm infants. Pediatr Ann. 2003;32:337-47. PMID: 12774709
4. Riant P, Urien S, Albengres E et al. High plasma protein binding as a parameter in the selection of betablockers for lactating women. Biochem Pharmacol. 1986;35:4579-81. PMID: 2878668
5. Bianchetti G, Boutroy MJ, Dubruc C et al. Placental transfer and pharmacokinetics of acebutolol and N-acetyl acebutolol in the newborn. Br J Pharmacol. 1981;72:135p-6p. DOI: doi:10.1111/j.1476-5381.1981.tb09112.x
6. Bianchetti G, Dubruc C, Vert P et al. Placental transfer and pharmacokinetics of acebutolol in newborn infants. Clin Pharmacol Ther. 1981;29:233-4. Abstract. DOI: doi:10.1038/clpt.1981.37
7. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk. Clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988;14:217-40. PMID: 3292101
8. Ho TK, Moretti ME, Schaeffer JK et al. Maternal beta-blocker usage and breast feeding in the neonate. Pediatr Res. 1999;45:67A. Abstract 385.
9. Board JA, Fierro RJ, Wasserman AJ et al. Effects of alpha- and beta-adrenergic blocking agents on serum prolactin levels in women with hyperprolactinemia and galactorrhea. Am J Obstet Gynecol. 1977;127:285-7. PMID: 556882

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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