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Sotalol Pregnancy and Breastfeeding Warnings

Sotalol is also known as: Betapace, Betapace AF, Sorine, Sotalol Hydrochloride AF, Sotylize

Medically reviewed on December 11, 2017

Sotalol Pregnancy Warnings

Benefit should outweigh risk.

AU TGA pregnancy category: C
US FDA pregnancy category: B

Comments:
-This drug should be used during late pregnancy only if the potential benefit outweighs the potential risk to the fetus.
-Beta-blockers may cause decreased placental perfusion (resulting in fetal death and premature birth), fetal and neonatal bradycardia, and hypoglycemia. This drug should be discontinued 2 to 3 days before the expected delivery date, if possible, to avoid increased uterine contractility and effects of beta blockade in the neonate.

-Animal studies have failed to reveal evidence of teratogenicity, but have revealed a slight increase in fetal death likely to be due to maternal toxicity at 16 times the maximum recommended human dose (on a mg/kg basis), and increased fetal absorptions at 100 times the maximum recommended human dose (on a mg/kg basis). There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Sotalol Breastfeeding Warnings

A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Other beta-adrenergic blocking drugs are preferred to this drug, especially while nursing a newborn or preterm infant, because of its extensive excretion into breastmilk, its renal excretion, and minimal safety data in breastfed infants.
-Adverse effects in the infant are possible.

See references

References for pregnancy information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Betapace (sotalol)." Berlex, Richmond, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Betapace (sotalol)." Berlex, Richmond, CA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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