Last update July 30, 2022

Sotalol

Limited compatibility

Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.

Sotalol is a noncardioselective beta-blocker used to treat life-threatening ventricular arrhythmias and to maintain sinus rhythm in atrial fibrillation or flutter. Oral or intravenous administration.

It is excreted in breast milk in an amount that could be significant due to reaching a relative dose > 20%. (Wagner 1990, Hackett 1990, O'Hare 1980)

No problems have been observed in infants whose mothers have taken it. (Ho 1999, Hackett 1990)

Some authors consider it a medication moderately acceptable with important reservations during breastfeeding (Malachias 2016, Tan 2001). American Academy of Pediatrics: medication usually compatible with breastfeeding. (AAP 2001)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (Hale, LactMed), especially during the neonatal period and in the event of prematurity.

Alternatives

  • Metoprolol (Safe substance and/or breastfeeding is the best option.)
  • Propranolol (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Sotalol in other languages or writings:

Tradenames

Main tradenames from several countries containing Sotalol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 309 daltons
Protein Binding 0 %
VD 1.6 - 2.4 l/Kg
pKa 10.07 -
Tmax 2.5 - 4 hours
17.5 ± 0.97 hours
M/P ratio 5.4 - 8.8 -
Theoretical Dose 0.6 - 3 mg/Kg/d
Relative Dose 20 - 90 %
Ped.Relat.Dose 60 - 100 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Malachias MV, Figueiredo CE, Sass N, Antonello IC, Torloni MR, Bortolotto MRF L. 7th Brazilian Guideline of Arterial Hypertension: Chapter 9 - Arterial Hypertension in pregnancy Arq Bras Cardiol. 2016 Abstract Full text (link to original source)
  4. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  5. Tan HL, Lie KI. Treatment of tachyarrhythmias during pregnancy and lactation. Eur Heart J. 2001 Abstract Full text (link to original source) Full text (in our servers)
  6. Ho T, Moretti M, Shaeffer I, Ito S, Koren G. Maternal β-Blocker Usage and Breast Feeding in the Neonate. Pediatr Res. 1999;45:67. Poster 385. Full text (link to original source) Full text (in our servers)
  7. Wagner X, Jouglard J, Moulin M, Miller AM, Petitjean J, Pisapia A. 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 Abstract
  8. Hackett LP, Wojnar-Horton RE, Dusci LJ, Ilett KF, Roberts MJ. Excretion of sotalol in breast milk. Br J Clin Pharmacol. 1990 Feb;29(2):277-8. No abstract available. Abstract Full text (link to original source)
  9. O'Hare MF, Murnaghan GA, Russell CJ, Leahey WJ, Varma MP, McDevitt DG. Sotalol as a hypotensive agent in pregnancy. Br J Obstet Gynaecol. 1980 Sep;87(9):814-20. Abstract

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