The Basics
What is Sotalol?
Used to treat irregular heartbeats.
Brand names for Sotalol
Betapace
How Sotalol is classified
Antihypertensive Agents, Adrenergic Beta-Antagonists, Antiarrhythmics
Sotalol During Pregnancy
Sotalol 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 Sotalol while pregnant
There are no adequate and well-controlled studies in pregnant women. Sotalol has been shown to cross the placenta, and is found in amniotic fluid. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on surface area). Animal reproductive studies are not always predictive of human response. Reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the MRHD (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. In rabbits, a dose of sotalol 6 times the MRHD produced a slight increase in fetal death as well as maternal toxicity. This effect did not occur at sotalol dose 3 times the MRHD. In rats a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD, produced no increase in early resorptions.
Taking Sotalol While Breastfeeding
What are recommendations for lactation if you're taking Sotalol?
Because of its extensive excretion into breastmilk, its renal excretion and minimal safety data in breastfed infants, other beta-adrenergic blocking drugs are preferred to sotalol, especially while nursing a newborn or preterm infant. Some authors recommend using sotalol during breastfeeding only while monitoring the infant closely for signs of beta-blockade.[1] Infants over 2 months of age have more mature kidney function and are less likely to be affected by sotalol in milk.
Maternal / infant drug levels
Because of its extensive excretion into breastmilk, its renal excretion and minimal safety data in breastfed infants, other beta-adrenergic blocking drugs are preferred to sotalol, especially while nursing a newborn or preterm infant. Some authors recommend using sotalol during breastfeeding only while monitoring the infant closely for signs of beta-blockade.[1] Infants over 2 months of age have more mature kidney function and are less likely to be affected by sotalol in milk.
Possible effects of Sotalol on milk supply
Relevant published information on the effects of beta-blockade or sotalol 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 Sotalol
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. Hackett LP, Wojnar-Horton RE, Dusci LJ et al. Excretion of sotalol in breast milk. Br J Clin Pharmacol. 1990;29:277-8. Letter. PMID: 2306424
2. Riant P, Urien S, Albengres E. High plasma protein binding as a parameter in the selection of betablockers for lactating women. Biochem Pharmacol. 1986;35:4579-81. PMID: 2878668
3. Atkinson HC, Begg EJ, Darlow BA. Drugs in human milk: clinical pharmacokinetic considerations. Clin Pharmacokinet. 1988;14:217-40. PMID: 3292101
4. O’Hare MF, Murnaghan GA, Russell CJ et al. Sotalol as a hypotensive agent in pregnancy. Br J Obstet Gynaecol. 1980;87:814-20. PMID: 7426541
5. Wagner X, Jouglard J, Moulin M et al. Coadministration of flecainide acetate and sotalol during pregnancy: lack of teratogenic effects, passage across the placenta, and excretion in human breast milk. Am Heart J. 1990;119:700-2. PMID: 1689933
6. 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.
7. 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
8. Schimmel MS, Eidelman AI, Wilschanski MA et al. Toxic effects of atenolol consumed during breast feeding. J Pediatr. 1989;114:476-8. PMID: 2921694
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.
